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Robert J. (don’t call me “Bobby”) Blaskiewicz’s #Epic Skeptic “Word-Salad” #Fail – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

Are you there ?
Okay, we might as well get started if were going to do this
Alright, so ummm I guess we can start with uhhh bit of a conversation
Uhhh
You’ve been on the Burzynski Hashtag for a long time – what’s you’re motivation ?
Okay
So what information have Skeptics posted that they uhhh that they missed that demonstrates that Burzynski’s uhhh treatments are effective ?
What, what have we missed ?
Well okay, uh one of the issues that Skeptics have with Burzynski is that in order to, let’s say, elevate uh the profile of his drug, in order to make sure that everybody who needs it can get, is to complete a phase 3 uh trial uh he started uh I believe was it just the one, right ?
Uhmmm, and that’s gone nowhere
In fact, it was withdrawn this I think within the last week
It doesn’t look like its going to happen, and this is, you know, for all the the phase 1 and phase 2 trials, those are very preliminary trials
Uhmmm, the phase 3 is is will be the gold standard, and also the bare minimum that that the larger medical community will accept uhhh as evidence, so it’s like you’ve lowered the bar for for evidence in a way that that you know oncologists don’t
The the
Right
So, do you think that there is a uh uh conspiracy to keep Burzynski from publishing ?
Right
Right
So, uhmmm, as far as I understand it The Lancet, uhhh the the question of The Lancet publication ehhh is par for the course, that most people are, when they get a speedy rejection from a uh uh, uh journal, are actually uh grateful, because that means there allowed to go ahead and submit their material to another journal more quickly and get it out there
Uhm, but the reaction that we saw on the side of the Burzynski camp was that, see, they’ll never publish us
Uhm, which is, eg, taken as far as I can tell as evidence of a conspiracy or that his name is is poison uh I mean, I think it is, but uhmmm, that wasn’t indicated in the in the rejection letter in order to uh claim that it is is to go beyond the evidence which again we’re not really willing to do
So, uhmmm what is the the ration the the something that I think a lot of of a lot of The Skeptics have been curious about when it comes to your your your blog and your behavior on-line uhhh is that that that, that the format of your blog does not make sense to us, we don’t understand exactly what you’re trying to do with it
Could you kind of clarify that for us because it’s uhhh long and it’s it’s intense and there’s a lot of emotion behind it but we don’t understand exactly, what it’s supposed to mean
Alright, ah have you read The Other Burzynski Patient Group ?
So, ahmmm what is your response say to the story of Amelia Saunders ?
Okay, what part of, what did I get wrong ?
Uh was that Amelia and Luna ?
Luna was the other one, correct
Oh, I, you’re talking, oh this is one of the very 1st ones that we did on the, on the site
Uhmmm, oh, her name is, her name escapes me at the moment
Um, but she wasn’t there for for very long but uh her condition deteriorated very rapidly
Uhmmm, and one of the questions that we had, we raised, is is, you know, you you don’t need to reach full dosage ’cause the the full dosage for these ANP seem to be pretty high, at least the sodium load that that that patients are asked to to carry, or required to carry if they they go on it
And we wondered if the sodium load was ah to great for someone who has a brain tumor, I mean uh, you know uh sodium load will increase your blood pressure, and these people have extra things in their brains that probably won’t react well to swelling, right, and and wont react well to pressure, so we were wondering, if in fact you don’t have to reach the full dosage in order to have uh severe side effects
Ummm, you know maybe you haven’t reached a therapeutic dose level, but that doesn’t mean that it didn’t have an effect on her
And you can clearly tell, that, you know in the videos, well at least the videos before the family took it down, that she was lethargic and a little bit out of it, she uh the the difference in her conscious state was no noticeable for anyone to see
Ummm, to, you know where she had been up and about to in her bed kind of slurring and and, and and and, in fact just disoriented, just looked like someone had taken the piss out of her
I mean, ummm, so that’s, that one, ummm, you know the critique that, reaching therapeutic levels and having a biological effect on someone are are clearly different things in her case
Uhmmm, now I never went on you know on to say ummm that uh she had uh reached therapeutic levels
Uhmmm, I I think as far as I went was that she went, she paid her $30,000 dollars and then she died
Uhmmm, and and and what part of that’s not true
Okay, so, um, going back to Amelia, um, some of the the most um I think the most serious charges is that we see a uh repeatedly in his uh uh stories of his patients, um those are all cited, those are all backed uh by, you know, um at least as good as anything the Burzynski Patient Group has ever done
Uhmmm, something that we see over and over are patients reporting over and over that signs of getting worse are signs if getting better
Um, in particular a, uh report that’s very common from from patients is that the center of their solid tumors are breaking up
One of the problems that we we we see is that that is more frequently a sign of ischemic necrosis that the tumor has outgrown its blood supply and that it’s dying on the inside
And when you see something like a 5th of the patients who we’ve been able to to document, reporting this excitedly, we get extremely concerned about what’s happening
Uhmmm, what part of that is not absolutely terrifying to you
Well, the the yeah I’ve never seen anyone say that the purpose of the antineoplastons is to cause uhhh, you know, to restrict the blood flow to the tumor and and and uh cause it to die that way, which is certainly one therapeutic approach that’s been, that’s been floated and research has been done on uh and might even be promising and uh what he’s saying is that cancer is caused by a lack of antineoplastons in the system and that basically what he is doing is antineoplaston uh uh supplement therapy uh rath, what’s the word I’m looking for, uhm uh, replacement therapy
Uh and there isn’t a doctor on the planet, uh not a medical specialist on the planet, who, I, who has identified at at as a contributing factor as a contributor to cancer or antineo or lack of antineoplastons
So
Why isn’t he, you know, you understand that these doctors, ummm like nothing is true or false because a doctor says it is true or false
Uhmmm it’s it’s it but when the entire medical community uhhh who are des are desperately are are every bit as tired of seeing patients die uhmmm and seeing patients suffer or as anyone else’s families are you you imagine what an oncologist sees in that office over the course of of a year and there’s going to be unimaginable suffering
I’m sure that they’re tired of that
And that they would, you know, that if there was the slightest hint that antineoplaston deficiency was a cause of cancer that it would make it into the literature, with or without Burzynski
Uhhh ummm, why should we trust him when he has uh the sole uh the only person who had identified antineoplastons as a contributor to cancer when he is the sole manufacturer of the of the therapy uh when he is the uh sole prescriber of the therapy and when he is, where the sole distributor of the therapy from his pharmacy
He’s read everything
I think
Can you go ahead and send me that link that that I saw in the chat that you had uh posted a couple of times in the chat
Could you send me that link, to that publication
I can give you a minute to to go find it if that’s
That would be good
Uhmmm
Well, yeah that’s a, that’s you know one of the major problems that this this cancer has is the location is such a pain to get to
Uhm, and often when we are talking about these cancers, the thing that gets me over and over and over, and this is something that I’ve learned from from working uh with others on the Burzynski Patient Group is what’s it like to be a cancer patient, only by proxy, man I couldn’t imagine really going through this myself, and, you know I’d hate to see my family go through this
That these people are at what could be described as a low point, they’re um uhhh, you get a diagnosis of uh brainstem glioma the prognosis is very bad
Uhmmm, there are only a few cases of people recovering from that, I mean they’re there uhm uhhh but, you know that it’s an, it’s an extremely grim prognosis
Uhhh and I worry that when they’re in that desperate state and especially let’s talk about the children, you have these kids who are uh you know 2 and 3 and have had this, you know uh awful diagnosis and the parents are willing to do literally anything to keep their kids alive
What protections are in place for patients as far as that these kids are and and their parents are protected
Who had the better results ?
Okay
Hmmm, yeah, the, Guy Chapman has just um uh tossed in a a, a comment
I guess uh that there are a lot of people who wanna talk to you (laughter)
Uh, Guy Chapman has just jumped in and said it looks like you forgot the phase 3 trial is withdrawn and none of the phase 2 trials were published
Uhmmm, this, this is not a minor thing for for for Skeptics
This, this is exactly what will convince us to get on board the Burzynski train is the publication of these trials
But even the preliminary trials, one has been finished, and none has been published in its entirety for over 15 years
When you consider that this is a, as you just pointed out, this is a a cancer, the, especially the brainstem gliomas
That these cancers uh the cases resolved fairly quickly, we know what the outcome are fairly quickly
Ummm, do you have any sense of when these trials are going to be published ?
From Laura ?
Right
When you, when you think about a major, sorry, go ahead
Yeah, right, uh
Antineoplastons has a better rate ?
Right
Right, one of the things that that there there are 2 points to be made here
Uhm, the 1st one is that major pharmaceutical companies that are getting this accelerated approval have a track record of producing results which Burzynski does not have
Secondly, when it comes to ummm the rates of antineoplastons, how can we possibly say without a single published trial he, that he has an improved rate over Temodar or anything like that, and that’s exactly what would show to us whether or not his rate is better, the the types of publications that he’s done, that look really good on paper, ummm, to the to the, the common persons eye are these case series where he goes through and picks out people who have happened to have survived
But what that doesn’t tell us is whether or not the antineoplaston had anything to do with it
What you need to do is go and separate the background noise, the random weird rare but very real survive, unexpected survivals that occur, and separate those, uhhh, from any effect of antineoplaston, he’s never done that
But if you think about that, I mean that if it does have a a an improvement rate above uh other treatments
That still has an improvement rate, you know, that, that would give another option to people, ummm, even if in the aggregate their rates aren’t better
It might work on some individuals tumors rather than on, you know, you you it it is it taken as a, as a lump but extend life by uh quality of life for 3 months or something um in some cases but, you know, it it still has an effect, a real effect, and deserves to be out there
That’s a long time when someone is dying
Well, one of
One of the problems that that doctors have in in this country when it comes to doing ummm antineoplastons studies to verify any any effect that uh Burzynski has uhhh I i think back to the one where people say well that the FDA sabotaged his trials, and
Well, if if you think about it though, um, the, the proposed action as I understand it of the antineoplaston is that it’s a deacetylase inhibitor, which slightly unspools DNA, that allows uh, which would allow uh proteins to get into a pair of damaged DNA
And we have drugs that do that which carry a much lower sodium load
Uh, um, it, that would have a therapeutic effect on and that the risks outweigh the possible benefits of using this one particular drug
Um, I’ve seen any number of people looking at um, if you look at the Luna ah Pettiguine uh uh story on The Other Burzynski Patient Group um you see that the doctor is absolutely horrified by the insane sodium load that that Burzynski’s patients are carrying
Um in in some ways that that sodium load is uh leading people to constantly drinking up to I’ve seen 12 liters of water a day
That’s not necessary for other deactsylace inhibitors
Um the, why would you prefer that to to another drug if it did essentially the same thing, that didnt have this massive side effect ?
thats not necessary for other deactsylace inhibitors
Well that sss I believe that that’s proposed by the researchers, the design trial, you know they they sign off on it but that is is, is up to uh Burzynski uh my uh David James @StortSkeptic on the
ah he has asked everything that Burzynski does looks sort of like the behaviors of pseudo-science
So what we’re saying uhhh he does uh uhhh Burzynski like for instance like I said he has vertically integrated, ah, he controls all parts from identification to the creation of the drug uh to the diagnosing uh well he doesn’t do the diagnosing but he does um um prescribe and distribute, he does all that vertically, which is actually something that snake oil salesmen do
Another thing that that’s a red flag in Skeptic circles is that his one compound seems to be a sort of panacea for all sorts of different types of, of of cancers, um where we know that cancer has a a varied uh, uh, ideology and and the uh panaceas are are are to be and a variety of different types of causes um, in fact in any one tumor you would, you could say that these, these tumors are are completely uh heterogenous
The idea that there’s gonna be one knockout, it seems rather unrealistic
Um, additionally he charges immense amounts of money for this drug, um, even though the components cost pennies
Um, on top of that, um, there’s something that he asks for a a huge payment up front
That’s something that’s been warned against for generations of uh by anti-quack um uh crusaders if if they’re asking for everything up front, then be afraid
Ummm, another thing is that uh the kind of cult that’s sprung up around Burzynski, uh, one that is immune to uh criticism, reason, and pits people who are doing standard cancer research, as enemies, um, creating a black and white version of the world where there are good people and there are bad people
There are people who are fighting the disease, and then there are people who are really helping the disease
I mean, if you look at the, the new web-site by the Burzynski patients fighting back group, they say support the cure not the cancer
That’s a manikin world-view of black and white
Um, these are all huge red flags, that you’re dealing with a quack
Um, why hasn’t Burzynski done anything to change that ?
Right
Well, there, this is important
This is really important though
Wha, when she’s talking about, that’s Luna Pettiguine’s mother, is is talking about the costs there
Uhmmm, you, when someone is not insured in in this country,
Ahm, the, the the base cost that that’s calculated is, is the hospital only expects to get a fraction, a tiny fraction of that back from the insurance companies, and that’s why the costs are so inflated
Um, usually, when a patient is self-pay there is a self-pay price which is a more reasonable price
Additionally, all of those therapies, have demonstrated efficacy, and if Burzynski were to demonstrate his efficacy, $30,000 dollars to start on a life-saving treatment for a child would be a steal, and he would earn every nickel of it
Um, so, those arguments hold very little weight with us
He has a a an enormous house that’s valued in the tens of millions of dollars, he could do that if if the other, the other thing he could do, and this, we would love to see him do this, wousa, would be apply to Federal grant
That, that would be amazing, if he could get a grant to study this stuff
But, you know, um, I I don’t think he’d be able to get one, I don’t think he’s shown uh that he can carry off a uh a research program responsibly
Uhmmm
Well
Oh he, have you noticed the the, the thing on his web-site where if you make a donation to the clinic it goes directly to him ?
Right
You know, you know
Ummm, o-kay
Uh, I want to turn this over to the people who are watching
Um, I want to give them a a chance to address you as well
Uhmmm, hi everyone
Uhmmm, so, um, let’s, let’s wait for for that to roll in, and I do wait to go back to the, the the, the and let’s be very specific about this, the the things that you see on The Other Burzynski Patent Group, a patient reporting that um uh getting worse is getting better
How do you explain that ?
Well that’s just a known side-effect, your going to know that going in, but we actually have people say
Are there, why why why not, these people, see this is the thing though
The reason that site was started was because the people that don’t make it don’t have a voice
And when you, when you whittle away, when you only look at the at the, the positive outcomes, which is exactly in Burzynski’s favor to only look at the positive outcomes, and to have no sense of how other people’s diseases progressed, right, you’re gonna get a skewed and inaccurate version of the efficacy of this particular drug
Now lets lets lets go back and not talk about Laura, lets talk about these patients who report symptoms of getting worse, as if they were signs of getting better
Some people say that oh it’s a healing crisis or it’s progression of the disease
Or other people say it’s breaking up in the middle, hurrah
No, it’s actually a tumor that’s growing
That record there, that’s being left by patients, whose stories are every bit as important as the as the stories of the patients who have lived, are painting a completely different picture
How do you explain that ?
Are they feeding these people their stories ?
Are they feeding these people their stories
Okay I’m going to go back, I want to point something else out to you
Um, I have to, I don’t remember the exact patient so I have to go back to my web-site to take a look at it
Um
Because we are, because we’re on a Google+ stream that that’s a lot of data it takes awhile to bring up my, my site
Let me
Uhmmm
Well, that seems to give him an instant out, no matter what happens
That turns his claims into something that’s unfalsifiable
If I could give you an example of what unfalsifiable is
Um, and I’ll I’ll draw an uh, uh, case, uh hypothetical case of um uh proposed by Carl Sagan as the invisible dragon in your garage
If you say you have have a dragon in your garage, um, you know, you should be able to go over and verify that there’s a dragon in the garage
So let’s say we go over to Carl Sagan’s garage and, you know
Well, I don’t see anything
Well it’s an invisible dragon
Well okay, well then, let’s uh spray paint it
Well, it’s incorporeal
Well, uh, let’s measure for the heat of the breath
Well it’s heatless flame that it breathes
And, you know, okay, well then we’ll put flour down on the ground to see that it’s it it’s standing there
And, oh no it’s ah it’s floating
Well, you know, at some point, when you can’t falsify something
When you cannot, even in principle, prove something false, it’s indistinguishable from something that’s not there
And that kind of out, that oh well the tumor can keep on growing
Th (laugh) that that that’s an invisible dragon, as far as I can tell
A every time that I and and and and , and David points this out, that um, you you know your not going to speculate about the the FDA but then at every turn your invoking the FDA as being obstructionist
I, I just find that to be contradictory and and self-defeating
Um, let me see
Well, that’s not necessarily true
I mean uh when it when it comes to the case um I’ve i’ve talked to oncologists about this
And when it comes to uh for instance in in this case it sounds like it was a pediatric patient who was dying, ummm, who had died, ummm, the,
the 1st inclination is to ascribe the death to, um, to the tumor, which actually, would be to Burzynski’s benefit if there were other cases, I’m not saying there were, but if there were other cases where this type of complication arose, and it was ascribed to the tumor they might well not do it, uh, do an autopsy
Um, it’s ah as you could imagine it could be very difficult for the families to do that especially when they have ooh ah, a possibility of what, you know, led to the ultimate demise, that didn’t involve them ultimately somehow being responsible for it, right ?
So, it it it doesn’t seem to me that necessarily an autopsy would be um a a done deal
Um, let me see
No we don’t and it would be irresponsible to completely speculate on on, on, the outcome of that uh, uh, uh, individual patient, I am still scrolling through looking for this story that I wanted to talk about
Uh, and, I guess I’ll
It should be in Amelia’s I I, I packed Amelia’s story with all the stories, um, that I could find um in what we’d written up already
Um
Hold on a sec
She is a cute kid though
Um, alright
Now, our favorite oncologist (laugh), as you keep putting it, um, uh, with with the Amelia story, um, uh, was able to correctly determine that the Saunders family, had a, did not understand the significance of this cyst that had opened up in, uh, that had opened up in the center of the tumor, in fact they were ecstatic
They were delighted
Um, the family, of Haley, um, S, also
Uh, the the family of Haley S., also, had the same reading given to them
Um, the same diagnosis uh same prognosis was to, was given to Justin B in 2006
A similar cyst in Lesley S’s story uh ah, was in 2006
Um, and that kept her on uh treatment for a a another month so that could be another $7,000 some odd dollars
We same thing in the, in the case of, uh, Samantha T in 2005
We see it again as far back as 1994, in Cody G’s story
And then lastly and and the worst uh thing that we’ve seen, the patients report that Burzynski himself told Chase uh Sammut
The exact same thing
Um, and that was a
Have you read Chase’s story
It would stick with you, because that case is grotesque
The parents, uh, there was even a uh, uh, a fight over whether or not the parents should be allowed to continue treating this kid
He was basically lying, uh, in a uh uh brain dead uh for all intents and purposes, uh, in a in a coma uh without possibility of reversal, in his parents living room for months
Um, eh, all the while, he’s still on the, uh, well I don’t actually, I can’t say that, I don’t exactly know if he was on the treatment the whole time
Um, but, we do have this pattern, that is there, of people believing, that this particular pattern is, uh, progress, a a is not progression of disease but is is inducement to to stay on, um, eh, and this has been going on for decades
Eh, eh just based on what we’ve been able to find that patients have been reporting this for decades
At some point, you would think that a doctor would realize that perhaps what these patients are walking away with is inaccurate
Why hasn’t that changed ?
E wel that that that that’s not it
This is this is like the 2nd day of oncology class, that that’s what the tumor looks like
People are reporting that the tumor is no longer growing, um, or that the growing has slowed after they’ve started
Well, okay
There, there is an explanation for that, and why you can’t take that as necessarily being evidence of efficacy
Ah, the tumor grows exponentially while the resources are available to it, but then it reaches a point where it’s a self-limited growth, so it, the time between uh doublings in size decreases logarithmically
Um, so this is, this is like basic tumor physiology that we’re talking about, and his patients don’t leave his office, knowing these facts, for decades
This doesn’t have anything to do with the, do with the drug
This this
But, but when it’s, this treatment is working or this is not evidence that the treatment is working
That’s pretty basic
I mean we’re not, we’re not talking about deactsylace inhibitors or anything like that were you’d really need to know something about
This is, whether or not, you’re getting the outcome that you want
This is the whole reason for going
And it has nothing to do with the with the with the drugs
Which is, which is like which we just pointed out was a was an invisible dragon
you’re you’re you’re assuming
You’re you’re you’re assuming that
You’re assuming that
Um, I’m not assuming that
Ultimately it would, but whether or not it it it had a genuine therapeutic effect is a different matter all together
Um, this, what would, what would convince you that you’re wrong
So you’re saying because the Orphan Drug Designation and the face that there’s a phase 3, therefor it works ?
So what you’re saying is there’s nothing that would convince you now, that it doesn’t work
O-kay
Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work
it’s it’s it’s up to Burzynski
It’s up to Burzynski to show that his drug does work
And it’s always been his burden of proof
He’s the one that’s been claiming this miracle cancer cure, forever
Um, I don’t know if you’ve read Jaffe’s book
There seems to have been a lot going on there you really should look at it because it’s it’s it’s kind of revealing
Um, that that that it seems that there was a lot of political pressure applied to the FDA which may have been, uh, uh, have influenced the way in which these these trials were approved
I I would say that it is a genuine con uh uh bit of confusion on the parts of Skeptics
We don’t know why the phase 3 trial was approved
I don’t know that we’ve seen even the phase 1 trials, we don’t know why he’s getting a phase 3
And there’s a real story in that, we think
Um, that we’d love to see, however we can’t see, however we can’t see it because of proti protri proprietary uh protections that the FDA is giving to Burzynski, right ?
They’re not sharing his trial designs because they are his trial designs, right?
That the makeup of his drug that he’s distributing are his, uh design, and his intellectual property
So the FDA is protecting him, uh from outside scrutiny
While you may imagine that that, that that the FDA is is somehow antagonistic toward him
They’ve given him every opportunity, over 60 opportunities to prove himself worth uh their confidence and hasn’t
Um, but I definitely recommend that you look at Jaffe’s book and you will see, I think, um that um it’s called um, uh Galileo’s
You know what it’s called, okay, yeah
Um, definitely look at that
Um, you, you will see, the ways in which, the way that we got to this point, isn’t necessarily having anything to do with the efficacy of the drug
That comes across very clearly
Um, you, you mentioned it yourself, he he’s done well to listen to Jaffe’s advice, right ?
So, there there’s a lot to that
Um, uh, but yeah, let me go back to the Twitter feed
Um
Well it sounds to me like they’re they’re not um, the the the you know, they’ve put the clinical hold on now because they now have evidence that somebody may have died because of the treatment
Um, I don’t know what the state of that is right now
Um, uh, oh my gosh, um, let me see
Someone has just sent me a, a ah a link to, are you following the Hashtag, as this is going on
Okay
I’m doing, I’m doing the 2 things at once and it’s um, ok ok well it’s well ok I can’t I can’t go in and read that right now
Um, I would, ok let me tell you exactly what it will take, for me to come around and promote Burzynski
Um, for me, he needs to get a publication in a uh, yeah, uh uh uh publication in a peer-reviewed journal, a respected peer-reviewed journal, not like the the Journal of Medical Hypothesis or things we just made up
Um, something, you know, a a good, respectable journal that oncologists would read, that research oncologists would read
I would need an completely independent group to replicate his findings, and then I’d be all for it
I would say that right now, the business model that the Burzynski Clinic seems to depend on, as best as I can tell from an outsider, that, um, uh, that it depends on people paying money up front
It doesn’t depend on him developing and taking away a viable drug, that he can market to the entire world
His business model as best I can tell, is to keep it in house
That seems, if it works, if his drug genuinely works, and he hasn’t sent it along to mass approval, where he gets, for a couple of years at least, you know, exclusive rights to produce and sell this stuff, for one of the most intractable diseases, uh that man eh can can can, you know, can get, um, that suggests to me that there’s something else going on here
Now, someone has just sent a a note, uh that he has failed 3 different Institutional Review Board audits; this is Guy Chapman, uh no other institution has a 3 for 3 fail, according to to Guy iye he knows no other one
Um, that 45% of phase 3 clinical trials fail due to deficient phase 2 design
Um, he has an approved phase 3, but phase 2 was deficient so phase 3 fails
Do you think that that could possibly have anything to do with why we’re not seeing the phase 3 advance
He’s claimed
He’s claimed
That’s a different thing altogether
And in fact
Well, you understand why they do that, because in order to, it’s
No, they do do this with other drugs, well, it depends on the type
Some drugs it’s ethical to give something completely questionable, what they want to make sure that they at least get the standard care, you know which includes radiation
Um, and radiation does seem to extend life, reduce the size of some tumors some times
Um, do you concede, that in order to have a phase 3, you do not need to have a successful phase 2 ?
When 45% of phase 3 fail because they have a deficient phase 2 design, do you concede that ?
Well, ok
It doesn’t matter where
It doesn’t matter where it comes from uh, um
So-kay, um that would be shooting the messenger as opposed to dealing with the question, but
the idea, the best, well, the best, well in that case the best response is “I don’t know”
There’s something that that we don’t know, you’re coming, honestly we didn’t know what to expect when we talked to you
We, were looking at the design, of your web-site and wondering whether or not we would be able to get a a coherent sentence out of you, because the web-site is disorganized, uh
Um, at at at at least it’s the organization is not apparent to the readers
Um, and um according to
No, that is tied together
But let me, we know that that the the, the central concern is Burzynski
Ah, the source of this ah of of those #’s that I just gave you, Chapman has just updated me and he says um that it is, and I’ll go back to the, the ADR research . com issues in clinical research, so it’s the question, Bay Clinical uh Research and Clinical Development, a white paper called “Why do so many pase 3 clinical trials fail ?
Uh, it’s prepared by Anastassios Retzios, Ph.D
Is Anastassios Retzios reliable ?
There is a correct here
Exactly
That’s the right answer
You don’t know
You don’t know
You need to look into it
Alright ?
Before you dismiss it you have to look into it
Everytime somebody throws uh uh something to me, I have to look into it
That’s just, it’s my responsibility as a reader
Um
What, what stuff would you like
What stuff would you like me to do ?
I generally, I don’t read your blog
Uh um, alright
Okay, I’ll look at that, and I will respond to it once I’ve taken a look at that, okay ?
Um, and I’ll respond on your web-site
Um, seems only fair
Um, one question I’d wondered, what is the Didymus Judas Thomas reference to
Oh, so this is the Doubting Thomas
This is the Doubting Thomas
Okay, so this is the one, you show me the, you put your your, the, your hand inside the wound
You know, Jesus says, basically, ok, bring it on, check me out, right ?
Okay
Alright
That that, I didn’t, I didn’t realize that he was also, that that was the same guy
So, it’s it’s the Doubting Thomas
Um, what we would say, um, is that if Burzynski is the savior that he claims to be, that he should, open up his trials, he should open up his uh research uh protocols um and just say, “Look, bring it on”
Check out these wounds
But he’s never done that
Instead he he he wants us to just take the words of of of of his apostles
I don’t necessarily trust his apostles
I don’t think that they’re unbiased
I wanna see the data
I wanna see the the wounds in his hands and the the mark on his side
Oh, hey when when we talk about The Other Burzynski Patient Group, I don’t make any pretensions to make that my site proves anything
I I I really don’t
It’s not my job to prove anything
It’s Burzynski’s job
It is a researchers job to prove these things
But we just pointed out, we just pointed out, that the FDA, often approves, phase 3 trials, based on flawed phase 2 clinical trials
That is therefor a real possibility in this case
Yes you would
T t and what I would honestly expect and hope, is that you would be honest about this, to yourself, and and and that’s the thing we don’t, we often don’t realize that we’re not being honest with ourself
I try to fight against it, constantly
But, um, uh but the way that you’d earlier phrased your uh your response to “could you possibly be proved wrong ?”, . . really did exclude other possibilities of of of of yourself being wrong
So if the FDA
Well I’m not talking about the Guy Chapman
What you off, when I asked you, yourself, you know, what would prove you wrong, you said that the FDA hasn’t approved a phase 3
Well, ok
Let’s let’s back, let’s back up
What would the FDA, what happens if the FDA occasionally op op opposes, approves uh phase 3 trials, based on bad phase 2 trials
Would that be, would that cause any doubt in your mind ?
About the efficacy of ANP
Yeah, hello, yeah, you’re back
Yeah Google+ is a little wonky sometimes
But, would, does, if you were to learn, that sometimes phase 3 trials, uh, are approved, and failed, based on flawed phase 2, would, would that make you reconsider your position of the phase 3 being evidence that it works
Uh um could you send me that link, the, the, um . me see
I’m just looking at other things that are coming in on the Hashtag right now
Um, so the ANP is Orphan Drug status but is it Orphan Drug for glioma ?
Is it sodium phenylbutyrate or is it the the versions of the drug, the AS10 stuff or A1 or whatever it’s called ?
Okay, that’s what has Orphan Drug status
Alright, I’ll look into that
I hope somebody is writing all this down out there, so that we can go back and look at these claims later, right ?
So, oh, um
Do you have any questions for me ?
I’ve spent a lot of times asking questions of you
Mhmm
Guy Chapman, throws up the the, the comment, permission to investigate is not evidence of anything other than evidence of a valid protocol, not a uh, evidence of efficacy, in and of itself
That’s another comment
Um, alright then, this is your chance t, there are lots of people have lots of questions about me out there
Uh, about what my motivations are and such
I might as well put that out on the table just so it’s on the record, is that I am taking exactly no money from anyone for this, and have gotten nothin’ but grief from a lot of people, even people who, even people who support me have given me grief for this
Um, just so that you know, um, there have been, some of the things that have happened, oh, this is an important point too
Um, that when we have criticized this, uh, a # of us, especially Gorski, uh myself, uh Rhys Morgan, uh, um, and and uh Popehat, the the lawyer, blog, uh, um, who else was on there, um, oh, the Merritts, uh, t, uh Wayne Merritt, and his family, people have been critical of of of Burzynski have faced retaliation for opposing him ah and intimidation, and including, um, I had my uh a couple weeks before Christmas my, my, the Chancellor of my University was contacted via e-mail, and uh Eric Merola said that I had been um, uh, been spreading mis truths about Burzynski, that I had been a be, on my my show um had said things that were demonstratively untrue, and he also said that the drug was FDA approved, which it, you know, that’s not right
But um, he said that he was gonna do, talk about me in his new movie, in, uh, relat, in millions of homes, um, and he wanted to get a statement from the University
The University of course ignored him, and immediately let me know that I was going to get smeared
Um, I consulted my lawyer and uh uh, you know, the best course of action was figured out, and um uh a Gorski has had his accreditation board contacted, he’s had his bosses contacted, Rhys Morgan received threats of liable suits from somebody who had been hired, by the clinic, to clean up his on-line reputation if he didn’t take down his on-line review of Burzynski, uh, had his a picture of his house sent to him, clearly the message being, “We know where you live kid,” uh, Wayne Merritt; a pancreatic cancer patient, this is something that, that people generally, do not recover from, like generally, die from, received phone calls at home, from, this individual, threatening him with lawsuits; he doesn’t have a law degree so he’s misrepresenting himself
Um, but all of this, was done, to critics
Do you think that is deserved ?
Do you think that that is right ?
Mhmm
Well to be fair
It it it doesn’t strike me as necessarily a “Free Speech” issue, you know
Was it down-voted ?
No
Mhmm
Mhmm
Well we do have for for for for one thing, um, I guess to understand is that we are uh motivated by um uh a respect, this is the one thing that that all Skeptics I think um are uh respect critical thinking, um, and um respect scientific uh a we we’re mostly scientific enthusiasts, there’s some Skeptics who are not um, uh, you know oh u space nerds, or whatever who are um just sc scholars and the humanities but for the most part we all respect scientific consensus and we respect scientific method and have an enthusiasm for living in the real world, this is something that like all of us us are about
And to that end, sometimes that influence is how we run, is how we decide to run our personal web-sites
Um, uh, that whether or not we want our, to give a platform to people who disagree with us, um, you know, uh, when we do, uh . . it it is our sandbox, you know, right ?
This, this, we’re allowed to to let whoever we want into our sandbox if we, you know, uh if we want
Did he, did he leave them up ?
Did he leave them up ?
Right, um, do you think that he is required to answer you
Right
Mhmm
Um so a a question uh why were why do you have so many Twitter and Wikipedia sock-puppets
Wikipedia
You left Wikipedia
Mhmm
Um a
Uh We have uh a response from David James, everyone uh gave you a fair shout
You were a spammer plain and simple
You couldn’t, you couldn’t
work out your questions
Twitter does not
Twitter does not block people for for arguing
Only for spamming and policy violations
Mhmm
Okay
Um, let me see
Each new account was blocked for additional violations of policies
Um, this is a uh uh referring to the Wikipedia rules too
Um, so
Um, Wikipedia, do you know why um they’ve locked the Burzynski page ?
Did you notice the part where he threatened, did you notice the part where he threatened to expose Wikipedia
We have to, well, they they uh are looking that it’s not one-sided information they want to show
Like they discuss, there is controversy about this guy
Yeah, Jaffe’s on there
Jaffe’s on there
uh well you could add that if you hadn’t gotten blocked
Okay
Um, so, who are you
She’s gotten threats
So we don’t know who you are
Like, she has suffered at the hands of some really mess, and she’s also, you have to realize she’s in the U.K, where libel laws are very lax at this point
That’s changing, ah, but uh, the the legitimate criticism, there is a big case last, me maybe 2 years ago of Simon Singh, talking about an alternative therapy, and, um, he was just saying that there’s no evidence for it but it’s promoted by um chiropractors, or something, or something like that
And he got slapped with a libel suit that cost him several years of his life and a lot of money
Um, so, there are several reasons why someone in the U.K. might uh be uh reticent to use their real name um, uh, and legitimate reasons
Um, in the U.S., I’m not sure that there is
I’ve been using my real name for a long time now
Um, you know, Gorski blogs under his real name, and is critical of uh, uh, also, let’s face it, everyone know, knows who “Orac” is
Um, how do we know that you don’t work for the clinic ?
Mhm
Well see, one of the the problems is, Ju, I don’t know if you were around for the BurzynskiSaves thing
Did you ever see that account ?
Mhmm
Right
Oh no, I mean you have a right to do that but but I I’ve found that posting under a pseudonym diminishes my credibility
Um, so, . . the quote was uh um, uh, “Happily promotes bogus therapies,” was Simon Singh’s quote that got him sued
Um, but Josephine Jones does it to, quote “protect her family”
Um
So there’s that
Um, are you afraid for you’re family ?
Um, you don’t see that there would be anything to gain from, from going on-record ?
Um I I haven’t, I’ve never, honestly, I’ve never seen a Skeptic actually go after a person individually
Um, you know, uh, you, unless they were doing colossal harm to people
Um, to to focus on an, uh, let’s say, call someone’s work for um, yeah
Cite one example, of a Skeptic making shit for a Burzynski shill or anyone else in real life
That’s a quote
That’s, that’s something coming in from, from Guy
Like had anyone ever contacted Sheila Herron, or has anyone to to um, go after her job, or go after um, you know, my brother has gotten stuff from people
He didn’t tell me because he didn’t want to upset me, but my brother gets things from Burzynski supporters that are violent and threatening
I get letters telling me that I suck cancer’s dick
Um, I I’ve all sorts of things um, and I just, I’ve never seen that, that intrusion into real life on the part of uh, um, uh, Skeptics
I’ve never seen them doing that type of of of stuff
I’ve never seen them threatening bogus lawsuits
Um, and I I I wonder there, if there is some sort of, what do you think accounts for that, that difference?
Mhmm
Mhmm
I’ve I’ve I’ve shown up on, you know, as you, as you might, I imagine you moni, you monitor the Hashtag, right ?
Okay
Um, which is, which is your right
Um, uh, but every so often I jump in and say, you know, this movie has some flaws in it
You know, that’s something I say rather frequently
Um, and I invite people, if they’re interested, to take a look at a couple of links
I don’t, I, you’ll notice that I no longer force people to like, “Well how do you explain this ?,” because that doesn’t seem to be very persuasive, or work at all
Ah, only people who are open minded to having their mind changed, those are the only ones I want to talk to
So I give them a choice
Kind of like Morpheus in The Matrix really
Um, b, that was a joke for me
Um, um anyway
Um, but, it it I, honestly, I would encourage you to go on-record, um, but I have, less than nothing invested in that, so, um
Uh, what’s next for you
Well what happens
Well what happens if he doesn’t understand what you’re saying ?
I mean one of the
I mean seriously
Well, one of the problems I think that a lot of Skeptics have had, in in back channel discussions about this is that we don’t understand exactly what you’re saying
We certainly don’t understand why you’re so attached to him if you’ve never had any uh, you know, close dealing with uh, uh, with Burzynski
We don’t really understand that
Actually, especially when you consider, that all the information that we’ve put forward, that we’ve backed up with statements from uh, you know, uh, it, it, the statements that we have from from patients saying that you know, we’ve we’ve, we were told that, no that’s not exactly, they put it usually that but that that we believe that getting worse is getting better
Like how could someone continue to defend someone, when we pile up all of these different, you know, sources, saying the same thing ?
It it is, it is beyond us and we wonder if there’s absolutely anything that we could say that would convince you otherwise
But, I mean, but that means
Everything on The Other Other Burzynski Patient Group is referenced
It goes
There’s very little on
thehoustoncancerquack
There’s very little on
thehoustoncancerquack in the 1st place
Eh, right
The they both go to the same place
Uh un but, you know, we, the thing that that totally befuddles us, and is just endlessly frustrating, is like how many more examples, of patients believing that getting worse is getting better, and it’s not us saying it, it’s the patients saying it
And how many more of those patients do we need to to give you before you will like reconsider that perhaps you might be wrong ?
I don’t, the thing is though that, that that’s a inver, shifting the burden of proof off of Burzynski
Burzynski has to prove them wrong, has to prove him right
The FDA is not there to say this doesn’t work
The evidence would be
The evidence
The evidence would be phase 2 trials
And ev the evidence would be a completed and published phase 3 trial
That’s not forthcoming
The phase 3
You don’t know that he’s trying
He’d start completing these trials
And he would, he would be soliciting um, uh, lots of um, uh, you know, you know he’d be putting out papers constantly um and if the the British Medical Journal example’s anything uh representative of how Burzynski works, he’d immediately tell everyone that his he’s being . . blackballed by the, by the journal, even when it’s just a courtesy that he gets a a rejection
So, I mean, honestly, um, saying “Well, when the F, FDA tells you that it doesn’t work, the FDA’s never gonna say that because that’s not their job
So, given that what would, how many more patients do we have to show you before you consider that you may be wrong ?
That’s not an option, because they’re never gonna do it
They relinquish, a lot of authority, over to Burzynski, and his Institutional Review Board, which, I would mention, has failed 3 reviews in a row
Right ?
It is Burzynski’s job to be convincing
It is not our uh, uh, it it it he hasn’t produced in decades
In decades
In hundreds and hundreds of patients, who’ve payed to be on this
Hell, we’d we’d we’d like a prelim, well when you’re talking about something that is so difficult as brainstem glioma, that type of thing gets, really does in the publishing stream get fast-tracked there
they test it
Yeah, and they they they want uh, that was evidence of fast-tracking is what, that rejection was uh e was very quickly
Um, so, uh, uh again, the FDA is not the arbiter of this
It’s ultimately Burzynski
So, how long will it be before Burzynski doesn’t publish, that you decide that uh perhaps he’s he’s, doesn’t have the goods ?
You’ve been speculating about what the FDA’s motivation are like crazy
Why not speculate about Burzynski a little bit
Well actually I’m not even asking you to speculate about Burzynski, I’m only asking you to tell me, how long would it take, uh how, for him to go unpublished like this, um, for this long, before you would doubt it ?
What ?
But these but but but that doesn’t have any bearing on
That doesn’t
Oh I’m not asking you how long, how long, would it take you for you to start doubting whether or not he has the goods ?
How long would it take ?
It’s a it’s a it’s a question that should be answered by a number uh uh months ?
Years ?
How long ?
It’s been 15 years already
I could push it back to 36 years
He hasn’t shown that it works for 36 years
I can do that
I was being nice
Perhaps based on bad phase 2
He withdrew
He withdrew the the phase 3 clinical trial
I that before recruiting,
although I’ve seen lots of people say they were on a phase 3 clinical trial
I wonder how that happened
Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?
He’s changed things
That The Lancet is a top-tier journal like New England Journal of Medicine
It’s basically be, besieged by uh 100′s of people submitting their, their, their reports
Um, it’s just, you know, let’s say he, someone has such a thin publishing record as Burzynski does, do you think that it’s likely that he will ever get in a top-tier journal ?
What about the the Public Library of Science ?
It’s not the only journal there
What about BMC Cancer ?
There’s lots of places that he can go
Um, and he doesn’t seem to to have evailed himself of that, as far as I can tell
And I would know because he’d get rejected, or he’d be crowing, you know
Either way, he’s gonna tell us what happens
He told us what happened with The Lancet, you know
I don’t have any evidence that suggests to me that he’s even trying
So let’s go back to this
How long will it take ?
How long will it take before you, the Japanese study’s interesting too because we should be able to find that in the Japanese science databases, and we can find, we can’t find it at all
We can’t find it anywhere
And, and those are in English, so it’s not a language problem
We can’t find that anywhere
We’ve asked
We asked Rick Schiff, for, for that study
And, and it hasn’t come to us
He is now I believe on the Board of Directors, over there
He should have access to this
We can’t get it
How how long will it take before you recognize that, nothing is forthcoming ?
How long would that take ?
Well, I mean, were talking about a blog here
We’re talking about life
No, we’re talking about a blogger’s feelings in that case
In in this case we’ren talking about, 1,000′s of patients, over the course of of of generations, you know
This is important stuff
This is not eh eh equating what’s happening to to patients with what’s happening to you is is completely off-kilter as far as I can tell
It’s nothing
It’s nothing like you not getting to say something on my web-site
You know
This is they they have thrown in with Burzynski, and they’ve trusted him, and he’s produced nothing
Nothing of substance
Nothing thas that has made all of that um, uh, n nothing th th th that uh his peers would take seriously
The other thing that that that strikes me now is that, you know, you you you you keep saying that, well Eric is going to to share things with you
Does it ever concern you eh uh eh occur to you that Eric might not be reliable ?
He then, and then he
And then he he, you know, the the the the dialogue that sprung up around that was, well see, he’s never going to get to get published
Well you’re just setting yourself up for wish fulfillment
You want him to be, persecuted, so you are ecstatic when he doesn’t get to publish, which is unfortunate for all the cancer patients, who really thought that one day, all the studies were going to be published
Where has Eric been wrong ?
It’s it’s it’s it’s a form letter
You know
They’re just saying, “No thanks”
“Thanks, but no thanks” is what they were saying, in the most generic way possible
Like I said, they’re besieged by researchers trying to publish
So, so, possibly
So possibly what you are saying is that they in fact have read it, and after having read it they’ve rejected it
Is that what you’re saying ?
Because that’s what peer-review is
Do you know it was the same editor, that it came from the same desk ?
You can’t make that assumption that that the form letter will be the same form letter every time
I mean you just can’t
I mean in in some ways we have a lot of non-information that you’re filling in, with what you expect, as as opposed to what’s actually really there, and I I I just think you’re putting too much uh stock in one uh, uh, in in in in this uh the publication kerfuffle
Um
Well, not necessarily
I’ve been in any # of professional groups where the organization is just not optimal, and publications certainly th there are all sorts of pressures from all sorts of different places
I I have no problems whatsoever with seeing that this might not be completely uh um uh streamlining uniform processes as possible
The fact that it’s not uniform, doesn’t have anything to do with Burzynski not publishing, not producing good data
Not just going to a, you know, god, even if, even if, let’s put it this way, even if he went to a pay to play type publication where you have to pay in order to get your manuscript accepted; and he has the money to do this, it wouldn’t take that much, and he were to put out a good protocol, and he were to show us his data, and he would make his, his his stuff accessible to us, then we could validate it, then we could look at it and say, “Yeah, this is good,” or “No, this is the problem, you have to go back and you have to fix this”
Right ?
So we really, every time we talk about the letter that he got, yeah that doesn’t have much to do with anything, really
We wanna see the frickin’ data
And if he had a cure for some cancers that otherwise don’t have reliable treatments, he has an obligation to get that out there anyway he can
And if if peer-review doesn’t, you know, play a, if peer-review can’t do it, you know, isn’t fast enough for him, then he should take it to the web, and he should send copies out to every pediatric, uh, you know, oncologist that there is
That’s the way to do it
Oh I, I I I certainly don’t think that he would put a lot of stock in it, but I, I, I know Dave Gorski enough, he wants this to work
He has patients who are dying, you know
And if if if let’s say that that Burzynski could get ah his gene-targeted therapy to work on breast cancer patients in in a reliable way, that would be, such a help to these people, that that Gorski’s trying to help
And, it it it doesn’t make sense, I mean, there, some of the best um, one of the the most important developments in medical history, was the development of of just washing your hands uh uh before uh uh going in and delivering a baby
Right ?
The guy who did it, was a colossal jerk, but it still worked and it’s the standard now
Right ?
Um, yea, it doesn’t matter now whether or not Burz, whether or not Gorski agrees with how Burzynski publishes
It’s the, it’s the data itself
If if Burzynski is is, is confident in his data, he will put it out there
Right ?
One way or the other
But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies
I mean, he has a
He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research
People who know what they’re talking about
To give him money to carry out his research
Right ?
Well what about all the other physicians, um, going back long before the Burzynski thing broke on-line
Of all these patients, with whom they have long-established relationships, and then doctors essentially after years, of treating these patients, basically saying, “I can’t work with you anymore if you go to Burzynski”
What about that ?
Di, are all of these doctors just as biased ?
Did he get burned at some point ?
We don’t know
Yeah, well, you wouldn’t expect Eric Merola to say that he got, that a doctor got burned
Would you ?
But he, he doesn’t have, he hasn’t given us his data
He’s given, he’s given, he’s given case studies
He’s done
Okay
Except for a ph, completed phase 3 clinical trial
Yeah
One of the things, one of the things that I’ve noticed going through these um, well, well there there is that
Uh, Guy Chapman, “It’s a blog, not a peer-reviewed publication”
Um, almost no treatment goes out without trials
Massive amounts of data are required
Um, so, it it is kind of, slightly disingenuous to hold uh Gorski to the same . . standard that you would, it on his blog
I think that professionally he would make, he he he would follow-up on these things, but u what I’ve noticed when you you mention these other people who are working with with Burzynski as co-investigators, the co- investigators don’t seem to have access to these, to these records
Um, you know, when they have to, when a patient has to, and often you have someone like a pediatrician, uh, signing on um uh to eh eh to work with with, uh and arrange care for patients when they’re out of state, away from Burzynski
Um, it’s it’s it’s often not an oncologist
It’s accurate to say that B Burzynski is not a board s uh certified oncologist
It’s accurate to say that no trial has been completed and fully published
Um, yeah it’s um, it it it if, all of the arguing on behalf of Burzynski doesn’t give him a single phase 3
It doesn’t give him um a uh uh of of a completed and and published phase 2
Uh, in in in that sense, you know, uh all the the the, you know, kind of back-peddling and and and trying to defend him is is going to, not going to help his case at all
You are, honestly as far as I can tell you are doing the um, you know, you’re you’re ah throwing up uh, uh, uh, you’re giving me another uh invisible dragon in the garage, um
What is the issue were not talking about
Yeah, but they
But they have track records that support the idea that you should trust them
Okay, so
What you’re telling me is that you trust the FDA to to be able to tell you when he’s not doing, good science, but also that you don’t trust the FDA
Do you see an inherent conflict there ?
Well, when I, whenever I would ask about, like, why would these trials aren’t happening uh and, you know, you say well the the FDA’s arranged it
The FDA’s in control
They sign off on these things
But they’re they’re they’re they’re at the same that they’re, they’re trustworthy they’re also not trustworthy depending on what you need for the particular argument at the time
You’re suggesting that they’re untrustworthy
I I would say that the the FDA has given Burzynski every opportunity for decades
Every opportunity
When he didn’t have r r really, he got special treatment as far as I can tell
Uh, the, I’m rather stunned every morning I wake up and don’t see in the paper, that that place has has been closed down
I, I really am
Uh, so, you know, that one doesn’t really fly with me either
Um
Do you know that the FDA pulled out of the prosecution ?
Did you know that the FDA pulled out of the prosecution um of his criminal case, because they were backing a researcher ?
Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
Right
And and, they declined to provide information that the prosecution needed
That’s important
That that that’s really important
That he has been given the benefit of the doubt, and he has come up wanting, for decades now
The, no, claims works
He claims works
One of the things I think
One of the things that I think is happening here
One of the things I think is happening here, is that lots of people have worked with Burzynski and then have stopped working with B Burzynski
Uh, you know, uh lots of uh uh uh these partnerships do not seem to work out in the end
I often wonder, if the uh, the way that these things are, are are playing out, because it’s s so reliable that they’re, that these partnerships are going to fail, I I wonder if th they are designed in such a way, that for instance, um a, uh, a a partner would be uncomfortable working
with him
Or um or that the specifications for what it takes to enter one of these trials is so high, that nobody will ever enter the trials
I mean, I wonder if they are, what, especially, like why hasn’t Burzynski left the country ?
That’s what I want to know
Exactly
If he was so, if he was s so persecuted and really cares about getting his treatment out to the world, why wouldn’t he ?
They’re, they’re lots of things going on here
David James has pointed this out, that a lot of questions I’m asking are not going answered
“I still don’t know how long it would take before you would have any doubts about Burzynski”
“I still have no idea, how often we can see patients reporting that signs of getting worse are getting better, before you would change your mind”
I’ve made it very clear that he just needs to have a completed study published and replicated before I support his right to go out and charge people what he’s charging for these, for these drugs, and I’m I’m just not seeing that here with you, and I I wonder what could come from, and don’t worry I will go to your site and I will comment on on on what you’ve run
Um, but, you know, I I I I it’s hard for Skeptics to imagine, what could be gained from engaging with you, if there seems to be no conceivable way, that we can, one, get a straight answer for, how many patients will have to report that getting worse is getting better before you starting doubting your opinion, or, uh, how many uh, uh, how many years does this have to go on before you decide that, “No, we probably just can’t produce the goods”
One of the interesting things about Doubting Thomas that I think you should definitely consider for yourself, is that at some point, when faced with the real opportunity to prove or disprove his assertions, he doubted himself
And that’s important
And that’s where you’re falling short in the analogy
I’ve laid out exactly what it would take for me to turn on a fucking dime
I have, I have made it abundantly clear what I need
Gorski has made it abundantly clear
Everybody else, Guy, and David, and Josephine Jones, uh, the Morgans, all of them have made it abundantly clear, what it would take to change our minds, and you’ve never done that
And even in this, this was an opportunity to do that
To come up with a basis for understanding, where it’s like, you know what, If we can show this, you know, if we can show a this guy, that, that, there, that his standards are not being met, then, you know, we could possibly have some sort of ongoing dialogue after this
Why wasn’t that study
Why wasn’t that , that that that, still . . again, it it doesn’t seem really to to approach the the the, main question here
You know, um . . what are the standards that you have that it isn’t, what are your standards to show that it isn’t efficacious ?
Why was the Mayo
Why was the Mayo study delayed ?
Well you said you had so many years before you finish it and go in
Why, why did it take so long ?
I have something for you, okay ?
Send me that
Could you send me that study the way that it was published because um, just just send me the final study, um, to my e-mail address
Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between
Why did it take so long for it, for it to come out
Right
Um, but it it would, perhaps, answer the question; because you’re using it as an example on the basis of which to dismiss criticism, whether or not, uh, it is the standard, and therefor you’re allowed to accept that Burzynski hasn’t published until 2016, or, um, it’s an anomaly, which is also a possibility, that most stuff comes out more quickly
I I, yeah, the other thing that David James points out is, you know, why 2016 when he’s had 36 years already ?
Treating people
You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
So, if you’re unsure about this stuff, if you’re unsure about the the time to publication, why are you defending it so hard, other than saying, “I don’t know, I really need to”
Uh about the
The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
I’ve backed-up everything that
Every time that I’ve tried
and then other people
Way back
It is about
It is about as efficacious
Yeah, I’ve, and and I based that on a a a that type of thing
You, you, you can read that how you want, right ?
There
He does have the accent though
Right ?
No
Alright ?
No, but listen, like, it it it’s not, it, we we don’t understand why you defend himself so hard, when there is such a paucity of of of information out there
Um
Even if it’s true or false you, honestly though
Even if it’s true or false, in in that particular instance, you know, eh let’s just say that you’re right
Gorski gets that point completely wrong
It has no bearing on whether or not, ANP works
That’s a Red Herring
You’re just focusing on this, on this little niggly stuff, where the real question, is does it work ?
Are patients getting better at a better rate then not
or otherwise ?
We’re were talking about whether or not there’s evidence to suggest it works
The FDA, see that’s the thing
You, the FDA are are, you know, you invest them with, we’re just, we’re just circling around again
Uh um, alright
Well, this has gone on for rather a, longer than I thought it would
Um, I, uh, wanna thank you for coming on here
I wasn’t sure that you would actually do it
Um, I’m glad that you did
I’m glad that we talked
Um, I will look at your web-site, and we will, uh, we, uh, you, oh make sure that I I go to your blog and and I talk there
Um
Please do
And I will look at those
Maybe not in the next few days; I’ve got a lot going on but
Alright
Um
I don’t think he is
I don’t think he’s afraid
I just think he’s got a lot going on
He is act, a full-time surgical oncologist and researcher
He does have insane am, he has to pick and choose his battles
And if, if if he saw that we were going to ultimately be circling around our same arguments again and again; kind of like we’ve done here, um, he uh, you, he doesn’t have time for that, I don’t think
Alright
I I would ask that you to to go back over The The Other Burzynski Patient Group and take their stories seriously, because they deserve at least the same amount of consideration that the survivors do
That’s my
That’s my kids, okay
Well, Thanks for much for talking
I greatly appreciate it
Alright
Take it easy

Thank you to the Didymus Judas Thomas Hipocritical Oath blog visitors

Thank you to the over 8,000 blog visitors

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Burzynski referenced by other Cancer researchers

Phase II trial of tipifarnib and radiation in children with newly diagnosed diffuse intrinsic pontine gliomas
http://neuro-oncology.oxfordjournals.org/content/13/3/298.full
University of California—San Francisco

Children’s Hospital Boston, Massachusetts

St Jude Children’s Research Hospital, Memphis, Tennessee

Seattle Children’s Hospital, Seattle, Washington

Children’s Hospital of Philadelphia, Pennsylvania

Children’s Hospital of Pittsburgh, Pennsylvania

Children’s National Medical Center, Washington, DC

Cincinnati Children’s Hospital Medical Center, Ohio

Neuro Oncol (2011) 13 (3): 298-306
doi: 10.1093/neuonc/noq202

5.723 Impact Factor

25. ↵ Burzynski SR
Treatments for astrocytic tumors in children: current and emerging strategies
Paediatr Drugs. 2006;8:167-178
http://link.springer.com/article/10.2165%2F00148581-200608030-00003
Pediatric Drugs
May 2006, Volume 8, Issue 3, pp 167-178

Burzynski (The SEC filings)

NET LOSS / NET (LOSS) / Net loss / Net (loss) / net loss / net losses / losses
8/31/2010 – $2,580,000 – 6 months ended
8/31/2010 – $(2,579,873) – 6 Months Ended
8/31/2010 – $1,205,000 – 3 months ended
8/31/2010 – $(1,204,550) – 3 Months Ended
5/31/2010 – $(1,375,323)
5/31/2010 – $1,375,000 – 3
months ended
2/28/2010 – $4,831,000 – year ended
2/28/2010 – $4,831,000 – fiscal year ended
2/28/2010 – $(4,830,610)
11/30/2009 – $(3,522,434)
11/30/2009 – $3,522,000 – 9 months ended
11/30/2009 – $1,209,000 – 3 months ended
11/30/2009 – $(1,208,930)
8/31/2009 – $2,314,000 – 6 months ended
8/31/2009 – $(2,313,502) – 6 Months Ended
8/31/2009 – $(1,194,255)
8/31/2009 – $(1,194,225) – 3 Months Ended
8/31/2009 – $1,194,000 – 3 months ended
5/31/2009 – $(1,119,277)
5/31/2009 – $1,119,000 – 3 months ended
2/28/2009 – $5,128,000 – year ended
2/28/2009 – $5,128,000 – fiscal year ended
2/28/2009 – $(5,127,729)
11/30/2008 – $3,915,000 – 9 months ended
11/30/2008 – $(3,914,731)
11/30/2008 – $(1,342,257)
11/30/2008 – $1,342,000 – 3 months ended
8/31/2008 – $(2,572,474)
8/31/2008 – $2,572,000 – 6 months ended
8/31/2008 – $(1,290,341)
8/31/2008 – $1,290,000 – 3 months ended
5/31/2008 – $(1,282,133)
5/31/2008 – $1,282,000 – 3 months ended
5/31/2007 – $(1,061,069)
5/31/2007 – $1,061,000 – 3 months ended
5/31/2006 – $(1,157,424)
5/31/2006 – $1,157,000 – 3 months ended
11/30/2005 – $(3,530,147)
11/30/2005 – $3,530,000 – 9 months ended
11/30/2005 – $1,039,000 – 3 months ended
11/30/2004 – $(3,666,261)
11/30/2004 – $3,666,000 – 9 months ended
11/30/2004 – $1,161,000 – 3 months ended
11/30/2002 – $3,201,000 – 9 months ended
11/30/2002 – $1,109,000 – 3 months ended
8/31/2002 – $2,093,000 – 6 months ended
8/31/2002 – $1,015,000 – 3 months ended
5/31/2002 – $(1,077,469)
5/31/2002 – $1,077,000 – 3 months ended
11/30/2001 – $3,952,000 – 9 months ended
11/30/2001 – $1,220,000 – 3 months ended
8/31/2001 – $2,733,000 – 6 months ended
8/31/2001 – $1,318,000 – 3 months ended
5/31/2001 – $1,415,000 – 3 months ended
5/31/2001 – $(1,414,934)
5/31/2000 – $(1,084,280)
5/31/2000 – $1,084,000 – 3 months ended
5/31/1999 – $(1,297,474)
5/31/1999 – $1,297,000 – 3 months ended
2/28/1997 – $541,825 – year ending
2/29/1996 – $50,499 – year ending

Operating loss before other income
2/28/2010 – (4,830,610) – Year Ended
2/28/2009 – (5,127,018) – Year Ended

8/31/2010 – $1,255,692 – Company had net operating loss carryforwards available to offset future income which may be carried forward and will expire if not used between 2012 and 2031 in varying amounts
5/31/2010 – $1,212,249 – net operating loss carryforwards available to offset future income which may be carried forward and will expire if not used between 2012 and 2031 in varying amounts
2/28/2010 – $1,188,847 – net operating loss carryforwards available to offset future income
8/31/2009 – $1,327,454 – net operating loss carryforwards available to offset future income which may be carried forward in varying amounts until 2030
5/31/2009 – $1,250,714 – net operating loss carryforwards available to offset future income which may be carried forward in varying amounts until 2030

Research and development costs
8/31/2010 – $2,421,000 – 6 months ended
Research and development
8/31/2010 – $2,420,725 – 6 Months Ended
Research and development
8/31/2010 – $1,122,339 – 3 Months Ended
Research and development costs
8/31/2010 – $1,122,000 – 3 months ended
8/31/2010 – $7,000 – other research and development costs
Research and development
5/31/2010 – $1,298,386
Research and development costs
5/31/2010 – $1,298,000 – 3 months ended
5/31/2010 – $6,000 – increase in other research and development costs
2/28/2010 – $4,480,000 – Total research and development costs for fiscal years ended
Research and development
2/28/2010 – $4,480,497
Research and development costs
2/28/2010 – $4,480,000 – fiscal year ended
2/28/2010 – $7,000 – decrease in other research and development costs
Research and development
11/30/2009 – $3,214,199 – 9 Months Ended
Research and development costs
11/30/2009 – $3,214,000 – 9 months ended
Research and development
11/30/2009 – $1,146,393 – 9 Months Ended
11/30/2009 – $1,146,000 – 3 months ended
11/30/2009 – $4,000 – other research and development costs
11/30/2009 – $3,000 – other research and development costs
Research and development costs
8/31/2009 – $2,068,000 – 6 months ended
Research and development
8/31/2009 – $2,067,807 – 6 Months Ended
Research and development costs
8/31/2009 – $1,076,000 – 3 months ended
Research and development
8/31/2009 – $1,075,784 – 3 Months Ended
8/31/2009 – $2,000 – other research and development costs
8/31/2009 – $1,000 – other research and development costs
Research and development
5/31/2009 – $992,023
Research and development costs
5/31/2009 – $992,000 – 3 months ended
5/31/2009 – $1,000 – other research and development costs
2/28/2009 – $4,894,255
2/28/2009 – $4,894,000 – fiscal year ended
2/28/2009 – $4,894,000 – Total research and development costs fiscal years ended
Research and development costs
11/30/2008 – $3,755,000 – 9 months ended
11/30/2008 – $3,754,621 – 9 Months Ended
11/30/2008 – $1,288,000 – 3 months ended
11/30/2008 – $1,287,762 – 9 Months Ended
Research and development costs
8/31/2008 – $2,467,000 – 6 months ended
Research and development
8/31/2008 – $2,466,859
Research and development
8/31/2008 – $1,254,049 – 3 Months Ended
Research and development costs
8/31/2008 – $1,254,000 – 3 months ended
Research and development costs
5/31/2008 – $1,213,000 – 3 months ended
Research and development
5/31/2008 – $1,212,810
5/31/2007 – $1,017,452
Research and development costs
5/31/2007 – $1,017,000 – 3 months ended
5/31/2007 – $2,000 – other research and development costs
Research and development costs
5/31/2006 – $1,101,112
5/31/2006 – $1,101,000 – 3 months ended
Research and development costs
11/30/2005 – $3,397,000 – 9 months ended
11/30/2005 – $1,059,000 – 3 months ended
11/30/2005 – $14,000 – other research and development costs
11/30/2005 – $7,000 – other research and development costs
Research and development costs
11/30/2004 – $3,469,000 – 9 months ended
11/30/2004 – $1,085,000 – 3 months ended
Research and development costs
11/30/2002 – $3,028,000 – 9 months ended
Research and development costs
11/30/2002 – $1,067,000 – 3 months ended
11/30/2002 – $6,000 – increase in other research and development costs
8/31/2002 – $1,961,000 – 6 months ended
8/31/2002 – $945,000 – 3 months ended
8/31/2002 – $4,000 – decrease in other research and development costs
8/31/2002 – $4,000 – which were partially offset by increase in other research and development costs
Research and development
5/31/2002 – $1,015,479
Research and development costs
5/31/2002 – $1,015,000 – 3 months ended
5/31/2002 – $10,000 – which were partially offset by increase in other research and development costs
5/31/2002 – $8,000 – increase in other research and development costs
Research and development costs
11/30/2001 – $3,695,000 – 9 months ended
Research and development costs
11/30/2001 – $1,165,000 – 3 months ended
8/31/2001 – $2,530,000 – 6 months ended
8/31/2001 – $1,234,000 – 3 months ended
Research and development
5/31/2001 – $1,296,310
5/31/2001 – $1,296,000 – 3 months ended
Research and development costs
5/31/2001 – $253,000 increase was due to increases in personnel cost
5/31/2001 – 24% increase was due to increases in personnel cost
5/31/2001 – $181,000 – increase
Research and development
5/31/2001 – $6,000 – increase
other research and development costs
5/31/2000 – $1,043,260
5/31/2000 – $1,043,000 – 3 months ended
5/31/2000 – $9,000 – 3 MONTHS ENDED – partially offset by increase in other research and development costs
other research and development costs
5/31/1999 – $1,247,320
5/31/1999 – $1,247,000 – 3 months ended
Total research and development expense
1997 – $993,947
1997 – $993,947 – for year ending
8/31/1997 – $364,000 – 6 months ended
Total research and development expense
1996 -$461,094
1996 – $461,094 – for year ending

net operating loss carryforwards expire as follows:
Year ending
2/28/
or
2/29/
2029 – Company minimum tax credit 2/28/2010
2028 – $722
2027 – $31,219
2026 – $47,083
2025 – $13,732
2024 – $59,706
2023 – $75,450
2022 – $19,315
2021 – $24,117
2020 – $49,976
2018 – $50,786
2017 – $511,871
2016 – $11,818
2013 – $261,184

1998 research and development plan calls for $700,000 development costs

Burzynski Clinical Trials (The SEC filings)

11/25/1997 – Filing Date
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
FORM 10-SB

Company’s IND applications have been approved by FDA and Company’s conducting FDA-approved clinical trials

at present time all Burzynski’s patients are enrolled in FDA approved clinical trials or have FDA approval under special exceptions

medical chemical compounds composed of growth-inhibiting peptides, amino acid derivatives and organic acids which are known under trade name “Antineoplastons

Company’s currently conducting Phase II clinical trials of Antineoplastons

Burzynski has developed 6 formulations of natural Antineoplastons and 6 synthetic formulations of Antineoplastons

All Phase II clinical trials currently sponsored by Company involve use of 4 formulations of synthetic Antineoplastons known as A10 and AS2-1 in capsules and injections

Company currently conducting laboratory research involving new generation of Antineoplastons A10 and AS2-1

anticancer activity of compounds has been documented in preclinical studies employing methods of cell culture, pharmacology, cell biology, molecular oncology, experimental therapeutics and animal models of cancer

At level of clinical studies, Company believes that anticancer activity of Antineoplastons is supported by preliminary results from ongoing FDA authorized Phase II clinical trials

cellular mechanism underlying anticancer effects of Antineoplastons continues to be investigated in Company’s own basic preclinical research program and independent laboratories around the world

review of work suggests several mechanisms may underlie antineoplastic activity of Antineoplastons

it has been found, in cell culture experiments, that Antineoplastons induce pathologically undifferentiated cancer cells to assume more normal state of differentiation

Cell culture experiments have shown Antineoplaston components can kill some cancer cells by activating cell’s intrinsic “suicide” program

data collected in cell culture experiments may or may not indicate mechanism of action of Antineoplastons in humans

At more molecular or sub-cellular level, cell culture experiments have shown Antineoplastons can block biochemical pathways involving oncogenes required to produce abnormal cell growth

cell culture experiments have shown Antineoplastons can increase expression of anticancer tumor suppressor genes

experiments conducted using human cancer cells, they may or may not indicate mechanism of Antineoplaston action in humans

In addition to original family of Antineoplaston compounds (the “Parental Generation”), Company continues development of 2nd generation of Antineoplastons

In cell culture experiments 2nd generation Antineoplastons developed by Company, have been shown to be at least a thousand times more potent then Parental Generation

Company developing 3rd generation structurally altered Antineoplaston Company believes will exhibit markedly improved anticancer activity in human cancer cell lines resistant to Parental Generation

increases of antineoplastic activity in cell culture experiments may or may not translate into increased efficacy in humans

Company involved in ongoing studies examining pharmacokinetics (absorption, distribution, metabolism, and excretion) and pharmacodynamics (dose-response) of Antineoplastons in patients with neoplastic disease

Company primarily engaged in research and development of drugs currently being tested for use in treatment of cancer, and provides chemical consulting services

All clinical trials are conducted in Houston

One of clinical trials is for treatment of breast cancer using Antineoplaston A10 capsules in combination with FDA-approved drug Methotrexate

All other clinical trials are for treatment of wide variety of cancers using only combination of Antineoplastons A10 and AS2-1

In most trials intravenous formulations of Antineoplastons are used

In few other trials, oral formulations of Antineoplastons are used

All Company’s clinical trials, except study with Antineoplaston A10 and Methotrexate involve use of Historic Controls

Where tumor size is used as Milestone

clinical trial Protocol describes

“complete response” is complete disappearance of all tumors with no reoccurrence of tumors for at least 4 weeks

“partial response” is at least 50% reduction in size of total tumor size, with such reduction lasting at least 4 weeks

A “response” is either complete or partial response

“Stable disease” is less than 50% reduction in size but no more than 50% increase in size of tumor mass, lasting for at least 12 weeks

“Progressive disease” is more than 50% increase in total tumor mass or occurrence of new tumors

protocols of Company’s clinical trials are a 2-stage design, wherein 20 patients are initially to be accrued

After specified time period, if 0 responses by patients after 1st 20 patients, trial will be discontinued and drug declared to have less than desired activity

If at least one response, trial will be continued until 40 patients accrued

If study continues, following conclusions according to protocols based on 40 patients can be made:

If 3 or fewer responses, there’s less than desired activity

If there are 4 or more responses, there is sufficient evidence to conclude that Antineoplaston regimen used shows beneficial activity

There are no clinical trials being conducted that involve “double blind” studies and all but one clinical trial involve no randomization into multiple treatment groups

one randomized trial is of A10 capsules plus Methotrexate, a proven chemotherapy agent, in treatment of breast cancer

In trial, persons are randomized into one of 2 groups
one group receives Methotrexate alone
one group receives Methotrexate and A10 capsules

10/1997 only 2 clinical trials reached Milestone

These are

Clinical Trial BT-11
and
Clinical Trial BT-18

Clinical Trial BT-18 involving intravenous administration of Antineoplastons A10 and AS2-1 in treatment of “mixed glioma”, a type of PMBT

3/1996 – trial approved by FDA
results evaluated after 9 patients accrued

Of these there have been
2 complete responses
2 partial responses

Another trial of Clinical Trial BT-11 involves patients with brain stem glioma

trial approved by FDA 5/1996

12 patients accrual
1 complete
3 partial responses

there can be no assurance that results of

Clinical Trial BT-11
or
Clinical Trial BT-18

can be repeated or that other clinical trials will result in same or similar responses

Company intends to release updated information when it becomes available

one trial that’s retrospective is CAN-1 Clinical Trial of patients treated by Burzynski through 2/23/1996

analysis has been made of patients with PMBT in CAN-1 trial

40 evaluable patients
17 experienced more than 50% reduction in size of tumors of whom 7 had complete disappearance of tumor

FDA indicated it will not accept data generated by this trial since it wasn’t wholly prospective one

Notwithstanding response results of

Clinical Trial BT-11
and
Clinical Trial BT-18

management believes it’s likely that FDA may require additional clinical trials based upon

Clinical Trial BT-11
and
Clinical Trial BT-18

Protocols be conducted by institution not affiliated with Company or Burzynski before advising that NDA filing is warranted

AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BL-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE BLADDER
3 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BR-10 PROTOCOL FOR RANDOMIZED CONTROLLED TRIAL COMPARING METHOTREXATE TREATMENT ALONE TO THE COMBINATION OF METHOTREXATE AND ANTINEOPLASTON A10
7 40
4/12/97 – Revised
7/28/97 – Revised

BR-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE BREAST 17 40
7/20/96 – Revised
4/29/97 – Revised

BR-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN PATIENTS WITH ADVANCED BREAST CANCER
6 40
8/26/96 –
12/10/96 – Revised
4/12/97 – Revised

BR-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH HIGH GRADE GLIOMA
9 40
3/1996

BT-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH GLIOBLASTOMA MULTIFORME
34 40
3/1996;

BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised

BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA
15 40
5/15/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
5/10/97 – Revised

BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

BT-14 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM
3 40
5/17/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

BT-16 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH LOW GRADE ASTROCYTOMA
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

BT-17 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH OLIGODENDROGLIOMA
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised

BT-19 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NEUROFIBROMA AND SCHWANNOMA
0 40
4/14/97 – Revised

BT-20 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME
35 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN
TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised

BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN
TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised

BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY
GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-24 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH EPENDYMOMA
7 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-25 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CRANIOPHARYNGIOMA
0 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-26 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CHOROID PLEXUS NEOPLASM
1 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-27 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH GERM CELL TUMOR OF THE BRAIN
0 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-28 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH MENINGIOMA
2 40
5/17/96 –
9/10/96 – Revised
4/14/97 – Revised

CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH REFRACTORY MALIGNANCIES
133 133
7/11/96 – Revised

CO-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE COLON
12 40
7/9/96 – Revised
9/7/96 – Revised
(RE-2 was added to this Protocol)
4/14/97 – Revised

CO-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 CAPSULES IN PATIENTS WITH ADENOCARCINOMA OF THE COLON
4 40
8/12/96 – Revised
12/2196 – Revised

ES-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE
ESOPHAGUS
4 40
7/9/96 – Revised
9/10/96 – Revised
10/30/96 – Revised
4/14/97 – Revised

HB-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH HEPATOBLASTOMA
7/8/96 – Revised
9/10/96 – Revised
3/2/97 – Revised
4/14/97 – Revised

HE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 IN PATIENTS WITH PRIMARY LIVER CANCER
1 40
2/12/97 – Origination date
5/28/97 – Revised

HN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE HEAD AND NECK
6 40
7/9/96 – Revised
9/10/96 – Revised
11/6/96 – Revised
added Children’s Informed Consent,
Revised 4/14/97 –

LA-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE LUNG
13 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
6/26/97 – Revised

LA-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH LARGE CELL, UNDIFFERENTIATED CARCINOMA OF THE LUNG
4 40
7/20/96 – Revised
9/28/96 – Revised
12/11/96 – Revised
4/14/97 – Revised

LA-5 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRONCHIAL ALVEOLAR CARCINOMA OF THE LUNG
1 40
7/20/96 – Revised
9/28/96 – Revised
12/11/96 – Revised
4/14/97 – Revised

LA-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE LUNG
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

LA-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SMALL CELL CARCINOMA OF THE LUNG
2 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

LA-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN PATIENTS WITH NON SMALL CELL LUNG CANCER
9 40
8/12/96 – Revised
9/9/96 – Revised
12/9/96 – Revised

LY-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA
2 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

LY-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, LOW GRADE
18 40
6/22/96 – Revised
8/12/96 – Revised
9/28/96 – Revised
10/23/96 – Revised
5/11/97 – Revised

LY-7 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, INTERMEDIATE GRADE
10 40
6/22/96 – Revised
8/12/96 – Revised
9/28/96 – Revised
10/23/96 – Revised
4/14/97 – Revised

LY-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, HIGH GRADE
1 40
6/22/96 – Revised
5/11/96 – Revised

LY-9 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MANTLE ZONE LYMPHOMA
4 40
6/22/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

LY-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 WITH CHRONIC MYELOGENOUS LEUKEMIA
0 40
10/4/96 – Revised
4/14/97 – Revised

LY-11 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MYCOSIS FUNGOIDES – SEZARY SYNDROME
0 40
9/10/96 – Revised
4/14/97 – Revised

LY-12 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
0 40
9/10/96 – Revised
4/14/97 – Revised

LY-13 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH PRIMARY LYMPHOMA OF THE GASTROINTESTINAL TRACT
0 40
9/10/96 – Revised
4/14/97 – Revised

LY-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
5/22/96 – Revised
9/18/96 – Revised
12/9/96 – Revised
4/14/97 – Revised

MA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MESOTHELIOMA
4 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT MELANOMA
8 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

MF-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT FIBROUS HISTIOCYTOMA
0 40
6/1997

MM-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MULTIPLE MYELOMA
5 40
7/26/96 – Revised
10/2/96 – Revised

MW-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MACROGLOBULINEMIA OF WALDESTROM
0 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

NB-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NEUROBLASTOMA
1 40
Orig: Dec 6, 1996
2/13/97 – Revised
4/14/97 – Revised

NE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NEUROENDOCRINE TUMORS
3 40
7/9/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

OV-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE OVARY
5 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

PA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE PANCREAS
11 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

PN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMOR OUTSIDE THE CENTRAL NERVOUS SYSTEM
1 40
Orig: Dec 6, 1996
2/10/97 – Revised
4/14/97 – Revised

PR-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
11 40
7/5/96 – Revised
10/3/96 – Revised
7/9/97 – Revised
10/14/97 – Revised

PR-5 PHASE II STUDY OF ADENOCARCINOMA OF THE PROSTATE WITH ANTINEOPLASTON A10 AND AS2-1 CAPSULES
16 40
5/16/96 – Revised
7/29/96 – Revised
10/3/96 – Revised
10/14/97 – Revised

PR-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN COMBINATION WITH TOTAL ANDROGEN BLOCKADE IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
0 40
8/1/97;
8/25/97 – Revised

PR-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
0 40
7/5/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
10/14/97 – Revised

RN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE KIDNEY
9 40
7/20/96 – Revised
9/28/96 – Revised
10/25/96 – Revised
4/14/97 – Revised

SA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SOFT TISSUE SARCOMA
8 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – revised

SI-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE SMALL INTESTINE
1 40
7/9/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

ST-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE STOMACH
6 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

UC-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE UTERINE CERVIX AND/OR VULVA
8 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

UP-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF AN UNKNOWN PRIMARY
6 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

WT-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH WILMS’ TUMOR
2 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

3/1/1997 Company entered into research funding agreement with Burzynski and terminated all royalty, rent, administrative services and supply agreements entered into 1/23/1992

Under research funding agreement Company agrees to undertake all scientific research in connection with development of new or improved Antineoplastons for treatment of cancer and other diseases

Company will hire personnel as required to fulfill obligation

Burzynski agrees to fund all basic research Company undertakes in connection with development of other Antineoplastons or refinements to existing Antineoplastons for treatment of cancer and other diseases

Burzynski agrees to pay expenses to conduct clinical trials

Burzynski agrees to provide Company laboratory and research space and office space at no charge

Burzynski may fulfill obligation in part by providing administrative staff for Company to manage business, at no cost

Burzynski agrees to pay full amount of monthly and annual budget or expenses for operation together with unanticipated but necessary expenses which Company incurs

3/1/1997 Company entered into research funding agreement with Burzynski and terminated all aforementioned agreements

term of Research Funding Agreement is one year, and automatically renewable for 3 additional one year terms, unless one party notifies other at least 90 days prior to expiration of term of agreement of intention not to renew agreement

In addition to termination provisions, agreement automatically terminates in event Burzynski owns less than 50% of outstanding shares of Company, or removed as President and/or Chairman of Board of Company, unless notifies in writing of intention to continue agreement notwithstanding automatic termination provision

Pursuant to Research Funding Agreement:

o Company agreed to undertake all scientific research in connection with development of new or improved Antineoplastons for treatment of cancer and other diseases

Company will hire personnel required to fulfill obligations under agreement

o Burzynski agreed to fund in entirety all basic research which Company undertakes in connection with development of other Antineoplastons or refinements to existing Antineoplastons for treatment of cancer and other diseases

o Burzynski agreed to pay expenses to conduct clinical trials

o Burzynski agreed to provide laboratory and research space, office space at facility, at no charge

o parties agreed Burzynski may fulfill obligations in part by providing administrative staff to manage business, at no cost

o Burzynski agreed to pay full amount of monthly and annual budget or expenses for operation of Company, together with other unanticipated but necessary expenses which Company incurs

Payments from Burzynski to Company of monthly budget made in 2 equal installments on 1st and 15th of each month

3/25/1997 Company and Burzynski entered into Royalty Agreement amended 9/29/1997, pursuant to which Burzynski agreed to act as principal clinical investigator of clinical trials necessary for obtaining FDA approval for interstate marketing and distribution of Antineoplastons

Payments made to Burzynski for 20% of cost of chemicals used in clinical trials being conducted by Burzynski 3/1/1996 – 2/28/1997

Burzynski is acting as principal investigator during clinical trials pursuant to 3/25/1997 Royalty Agreement between Company and Burzynski

11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing

12/10/1997
http://www.siliconinvestor.com/readmsg.aspx?msgid=2965068
Burzynski Research Institute Advances Clinical Trials for New Cancer Treatment and Completes New SEC Filing

HOUSTON–(BUSINESS WIRE)
12/10/1997–Burzynski Research Institute Inc.

Company announced new clinical trial earlier this year for experimental drugs, ANTINEOPLASTONS, for treatment of liver cancer

Company plans to submit results of current clinical trials to FDA 1/1998

If FDA finds results of trials sufficiently promising, Burzynski Research Institute Inc. will initiate procedure to generate data which will support New Drug Application (NDA)

BRI retained services of Brewer-Gruenert Capital Advisors, L.L.C., in Houston, to guide Company in preparing for expected growth based upon expectations of positive results of latest round of clinical trials

currently conducting approximately 72 FDA approved clinical trials

12/10/1997 – Burzynski Research Institute is sponsoring 72 Phase II Clinical Trials of ANTINEOPLASTONS in treatment of variety of cancer types and advanced stages

Early clinical results indicate particular promise with malignant brain tumors and lymphomas

interim analysis of 3 clinical studies indicates that 33% to 50% of evaluable brain tumor patients accomplished either complete tumor elimination or reduction of tumor size by more than 50%

5/31/2000
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-514477.txt
5/31/2000 5/31/1999
10QSB
5/31/2000 – CONFORMED PERIOD OF REPORT
5/11/2001 – FILED AS OF DATE

STANDARD INDUSTRIAL CLASSIFICATION:

IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]

5/31/2000 – quarterly period ended

currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs which are regulated by FDA

Company currently conducting 72 FDA approved clinical trials

5/31/2001 (7/12/2001)
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-523630.txt
CONFORMED PERIOD OF REPORT: 5/31/2001
FILED AS OF DATE: 7/12/2001
10QSB

Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations, however, at this time none of antineoplaston drugs have received FDA approval

significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs regulated by FDA

Company believes Antineoplastons are useful in treatment of human cancer and other diseases of body and is currently conducting Phase II clinical trials of Antineoplastons

Burzynski’s medical practice has
successfully funded Company’s research activities over last 17 years and, in 1997, medical practice was expanded to include traditional cancer #Burzynskitreatment options such as chemotherapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in Antineoplaston clinical trials

As result of expansion of Burzynski’s medical practice, financial condition of medical practice has improved Burzynski’s ability to fund Company’s operations

Company currently conducting 72 FDA approved clinical trials

5/31/2002 – quarterly period ending
http://www.sec.gov/Archives/edgar/data/724445/0000912057-02-027187.txt
5/31/2002 – CONFORMED PERIOD OF REPORT
7/12/2002 – FILED AS OF DATE
FORM 10-QSB

Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations

A significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs which are regulated by FDA

Company is currently conducting approximately 72 FDA approved clinical trials

1/14/2003 – Filing Date
11/30/2002 – Period of Report
http://pdf.secdatabase.com/1129/0001047469-03-001370.pdf

currently conducting clinical trials on various antineoplastons in accordance with FDA regulations

currently conducting approximately 72 FDA approved clinical trials

Drugs in R & D (Drugs in Research and Development)

2003 – Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report

http://www.ncbi.nlm.nih.gov/m/pubmed/12718563

Drugs R D. 2003;4(2):91-101

6 months median duration of treatment

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003 – Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report

http://www.ncbi.nlm.nih.gov/m/pubmed/15563234

Drugs R D. 2004;5(6):315-26

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma

4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy

19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

10 patients are alive and well from 2 to >14 years post-diagnosis

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004 – Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

11/10/2004
http://www.sec.gov/Archives/edgar/data/724445/000104746904033767/0001047469-04-033767.txt
Burzynski Research Institute, Inc., announced signing Financial Advisory and Consulting Agreement with Millennium Energy Ventures.com, LLC (“MEVCO”)

Agreement provides BRI with access to MEVCO’s advisory services related to manufacturing realignment, pharmaceutical plant expansion, corporate focus and other consulting services to support FDA approval process for Antineoplastons A10 and AS2-1 for treatment of brain stem glioma

Press Release
11/9/2004
“Burzynski Research Institute, Inc. and Millennium Energy Ventures.com, LLC Sign Agreement

HOUSTON, TX
Burzynski Research Institute, Inc. and Houston based Millennium Energy Ventures.com, LLC, (MEVCO) announced today signing of Financial Advisory and Consulting Agreement that provides BRI with access to MEVCO’s advisory services related to manufacturing realignment, pharmaceutical plant expansion, corporate focus and other consulting services to support FDA approval process for Antineoplastons A10 and AS2-1 for treatment of brain stem glioma

This agreement is part of BRI’s strategy to facilitate fast track completion of necessary FDA approval process to bring treatment to the market place

Millennium EnergyVentures.com, LLC, is focused on providing financial and management expertise to technology-oriented growth companies in Energy and Medical sectors

firm focuses primarily on
energy technology markets including:

Enabling Technologies and Infrastructure, Power, Water, Communications, Oil and Gas, and Life Sciences

11/30/2005 – For the quarterly period ended
http://edgar.secdatabase.com/1472/95012906000296/filing-main.htm

significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, regulated by FDA

Company is currently conducting 35 FDA-approved clinical trials

Drugs in R & D (Drugs in Research and Development)

3/2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma

http://www.ncbi.nlm.nih.gov/m/pubmed/16484713

Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG

14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections

5 months median duration

Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

5/31/2007 – quarterly period ended
http://edgar.secdatabase.com/1173/110465907054073/filing-main.htm

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

A portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

currently conducting 27 FDA-approved clinical trials

Drugs in R & D (Drugs in Research and Development)

2007 – Recent clinical trials in diffuse intrinsic brainstem glioma

Review Article

http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html

E. Multitargeted therapy

Antineoplaston A10 injections (A10) consist of synthetic phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (isoPG) in a ratio 4:1

antineoplaston AS2-1 (AS2-1) consists of PG and phenylacetate sodium (PN) in a ratio of 1:4

Phase II studies with ANP included patients with DBSG began 1988
(Burzynski, 2004a)

Only small # of patients with DBSG involved in most studies, which dealt with broad spectrum of primary brain tumors
(Burzynski, 2004a)

1996, phase II study of ANP in patients with brainstem gliomas opened and nearing completion
(Burzynski et al, 2003, 2004a, 2007)

studies are conducted at Burzynski Clinic and monitored by FDA and Institutional Review Board (IRB)

most recent report describes results in children with newly diagnosed DBSG
(Burzynski et al, 2007)

20 evaluable patients
5 with high-grade gliomas

overall survival (OS)
2 years – 40%
5 years – 30%

CR – 30%
PR – 10%
SD – 20%
PD – 40%
(Burzynski et al, 2007)

study closed for accrual and final results will be evaluated before end of 2007

Phase III protocol currently under FDA’s review

Results summarized in Table 2

proposed antineoplastic activity of ANP in DBSG consists of targeted therapy affecting AKT2 and TGFB1 pathways (PG), RAS, TP53, and p21 (PN) MYCC (PG and PN), MAD (PG), INI1 (PG), and apoptosis (PG and isoPG)

PG is formed in patient’s liver from PN and PB, but doesn’t share with PN and PB an inhibitory affect on HDAC

details of these mechanisms have been described previously

(Castillo et al, 1991; Liau et al, 1992; Adam et al, 1995; Liu and Samid, 1995; Shack et al, 1995; Danesi et al, 1996; Gorospe et al, 1996; Prasanna et al, 1996; Adam et al, 1997; Engelhard et al, 1997; Harrison et al, 1998; Ng et al, 2000; Witzig et al, 2000; Li et al, 2001; Burzynski et al, 2003, 2004a,b, 2005; Waldbillig and Burzynski, 2003; Burzynski, 2004b, 2006a,b)

DBSGs remain some of most tragic diagnoses in oncology

general opinion of neuro-oncologists that results of treatment for DBSG constitute worst response in all primary brain tumors

DBSGs occur usually in children, in whom brain tumors in general are 2nd most frequent malignancy, and most common form of solid tumors

Due to poor response, # of clinical trials in DBSG is small, and there isn’t much interest in bringing new agents into approval process by pharmaceutical companies

Results of treatment with antineoplastons A10 and AS2-1 (ANP) in patients with diffuse, intrinsic brain stem glioma

Author – Burzynski et al, 2007
Phase II – Study Type
N – newly diagnosed tumor – Tumor Type
20 – # of patients
ANP – Treatment
ANP – antineoplastons A10 and AS2-1
Efficacy
overall survival
2 yrs / 5 yrs
40% / 30%
median survival time
16.4 – months

6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease

Most results of phase II trials with targeted therapy and ANP have been presented at oncology meetings and published as abstracts

It was decided to include data from meeting abstracts in order to present most up to date results, but they should be treated with caution until they pass scrutiny of peer review

Children, older than 3 years, and young adults with newly diagnosed tumors, are usually temporarily helped with standard radiation therapy, but it’s estimated that less than 10% of them will survive 2 years

Children, younger than 3 years, adults after age 40, and patients with high-grade glioma pathology have very grave prognosis, and median survival is similar to supratentorial GBM, or worse

Children diagnosed with DBSG and neurofibromatosis 1 have better prognosis, except those that show contrast-enhancement on MRI

prognosis is especially grave for patients with recurrent DBSG, who typically don’t survive longer than 6 months

Targeted radiotherapy and bevacizumab in combination with irinotecan may offer hope, but they would require further clinical trials

The patients with recurrent DBSG can be helped with treatments currently in phase II clinical trials

The results of phase II trials in DBSG with ANP compare favorably with responses and survival data in radiation therapy and chemotherapy trials

Currently conducted phase II studies are closed for accrual and nearing completion, and phase III studies are scheduled to open soon

Introduction of new multitargeted agents and acceleration of basic and clinical research in DBSG may offer better chances in the future

http://www.wikinvest.com/stock/Burzynski_Research_Institute_(BZYR)/Liquidity_Capital_Resources
Since 2009, permission for final phase of FDA clinical testing to allow Antineoplastons to be “FDA-approved” has been granted

only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in Phase 3 trials, claiming it would be “unethical” not to do so

In 2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close

Phase III trials are 3rd and final phase before reaching FDA approval

trials could begin worldwide in 2010, barring ability to raise money to fund them

FDA has officially mandated that some patients participating in these Phase III trials be subjected to radiation treatment while simultaneously receiving Antineoplaston treatment—claiming it would be “unethical” not to do so

1/13/2009 Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy, Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma
EX-99.1 4 a09-2965_1ex99d1.htm EX-99.1
Exhibit 99.1
HOUSTON, TX – 1/13/2009 – Burzynski Research Institute, Inc. today announced its reached an agreement with US FDA that enables company to move forward immediately with pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

Antineoplaston therapy (ANP) uses synthetic version of naturally occurring peptides and amino acid derivatives found in human body to target and control cancer cells without destroying normal cells

agreement was made under FDA’s Special Protocol Assessment (SPA) procedure and means that design and planned analysis of Phase III study is acceptable to support a regulatory submission seeking new drug approval

“We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant and challenged further by severely limited treatment options and clinical trials that could expand and discover new, efficacious therapies,”

said Burzynski

“The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management.”

“BRI has reached important milestone independently without financial backing from government, and without major pharmaceutical partner—a unique accomplishment in the oncology field

From inception, we’ve been committed to developing a targeted gene therapy option that’s less aggressive on the body than conventional therapies and have made considerable progress on steps mandated by FDA to bring a new drug to a patient community and cancer type that has unmet needs.”

About Phase III study

primary objective of randomized study is to compare overall survival of children with newly-diagnosed diffuse intrinsic brainstem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) & AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone

DBSG are considered to be 1 of most difficult types of cancer to treat

It combines highly malignant characteristics with very difficult location of brainstem

DBSG are inoperable because they involve most of brainstem (diffuse and intrinsic)

Number of children in US with brainstem gliomas is approximately 660

Absent treatment, survival rate from time of diagnosis is 6 months or less

At present, there are no standard curative treatments for the disease

RT is only treatment that may slow its progress, but at 2 years 93% of children with this type of cancer die, and none survive for 5 years

Other conventional treatments such as chemotherapy have generally been tried in clinical trials but are shown to be ineffective

There are no pharmacological treatments approved for DBSG at this time

Research and development efforts are focused on basic ANP research and 19 Phase II clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465909043323/0001104659-09-043323-index.htm
For quarterly period ended 5/31/2009
5/31/2009 – Period of Report
7/15/2009 – Filing Date Changed
Form 10-Q

12/2/2008 Company announced orphan drug designation of Antineoplastons A10 and AS2-1 was expanded to treatment of all gliomas

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

Company is currently conducting 12 FDA-approved clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465909059014/0001104659-09-059014-index.htm
quarterly period ended 8/31/2009
8/31/2009 – Period of Report
10/15/2009 – Filing Date Changed
Form 10-Q – Quarterly report

9/9/2009 Company entered into Clinical Study Agreement with University of Alabama at Birmingham pursuant to which Company retained University to provide following services in connection with clinical trials of Antineoplastons:

develop and implement statistical plans

analyze and manage data

review and amend Case Report Forms (CRFs)

prepare statistical reports for Data Safety Monitoring Boards (DSMB) and US FDA

services will be performed for certain protocols listed in Agreement

Agreement will terminate at completion of protocols listed in Agreement, however, either party may terminate Agreement, with or without cause, by giving 30 calendar days’ prior written notice

5/1/2007 – 8/31/2009 – $24,641 – Company paid University for services previously provided which was accrued during 3 month period ended 8/31/2009

Subsequent services are billed to Company on monthly basis

All rights, title and interest in all data and reports generated in performance of services, pursuant to Agreement, are sole and exclusive property of Company

Company intends to enter into clinical development agreement with contract research organization for services relating to Phase III clinical study, including initially a feasibility analysis of patient enrollment and site requirements of planned study

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

Company is currently conducting 12 FDA-approved clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910031825/0001104659-10-031825-index.htm
fiscal year ended 2/28/2010
2/28/2010 – Period of Report
6/1/2010 – Filing Date Changed
Form 10-K

Burzynski has developed 6 formulations of natural Antineoplastons and 6 synthetic formulations of Antineoplastons

All Phase II clinical trials currently sponsored by Company involve use of 4 formulations of synthetic Antineoplastons known as A10 and AS2-1 in capsules and injections

Company is also conducting laboratory research involving new generations of Antineoplastons A10 and AS2-1

Orphan Drug Designation

9/7/2004 FDA granted “orphan drug” status to Company’s Antineoplastons under Orphan Drug Act of 1983

In enacting Orphan Drug Act of 1983, Congress sought to provide incentives to promote development of drugs for treatment of rare diseases

drug may be considered for orphan drug designation if drug is intended to treat rare disease or condition affecting fewer than 200,000 people in US or, even if drug treats a disease affecting more than 200,000 people in US, drug isn’t expected to be profitable from sales in US

Subject to applicable laws and regulations, 1st sponsor to obtain FDA marketing approval for a drug with orphan drug designation for designated disease or condition receives limited marketing exclusivity for 7 years; no other sponsor may bring to market “same drug” for treatment of same disease or condition for period of 7 years from date application is approved by FDA

drug with orphan drug designation must meet same criteria for safety and efficacy as drug without orphan drug designation

Company began Phase II clinical studies in 1994 with 4 studies

At that time, a number of patients were also receiving Antineoplastons at Burzynski’s clinic in Houston, Texas (the “Burzynski Clinic”) outside clinical trials

2/23/1996 FDA requested that all then-current patients of Burzynski Clinic desiring to continue Antineoplaston treatment be admitted to Phase II Study, according to Protocol CAN-1

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
quarterly period ended 5/31/2010
5/31/2010 – Period of Report
7/15/2010 – Filing Date Changed
Form 10-Q

Company is primarily engaged as research and development facility for Antineoplaston drugs being tested for use in treatment of cancer

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of brainstem glioma

2008 FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for the treatment of all glioma

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910001658/0001104659-10-001658-index.htm
quarterly period ended 11/30/2009
11/30/2009 – Period of Report
1/14/2010 – Filing Date Changed
Form 10-Q

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of brainstem glioma

During 2008, FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of all gliomas

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

Company is currently conducting 12 FDA-approved clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
quarterly period ended 5/31/2010
5/31/2010 – Period of Report
7/15/2010 – Filing Date Changed
Form 10-Q

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs regulated by FDA

Company believes Antineoplastons are useful in treatment of human cancer and currently conducting Phase II clinical trials of Antineoplastons relating to treatment of cancer

Upon completion of assessment, randomized, international phase III study will commence

9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treating patients with brainstem gliomas

1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)

agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval

2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

Upon completion of assessment, randomized, international phase III study will commence

study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone

Company is currently conducting 5 FDA-approved clinical trials

8/31/2010 (10/15/2010) 10-Q
http://edgar.secdatabase.com/541/110465910052441/filing-main.htm
8/31/2010 quarterly period ended

Company is currently conducting 5 FDA-approved clinical trials

A10 & AS2-1 in children w/high grade glioma

19 – Ptnts Accrued
11 – Evaluable Ptnts
1 / 19.1% – #&% of Ptnts Show Complete Resp
3 / 27.3% – #&% of Ptnts Show Partial Resp
3 / 27.3% / #&% of Ptnts Show Stable Disease
4 / 36.4% – #&% of Ptnts Show Progress Disease

Certain prospective protocols which have reached a Milestone as of May 1, 2012

The results of Protocols
BT-06
BT-07
BT-08
BT-09
BT-10
BT-11
BT-12
BT-13
BT-15
BT-18
BT-20
BT-21
BT-22
BT-23
are set forth below (as of May 1, 2012)

A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma

Optic Nerve Glioma
Drug: Temozolomide
Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
Phase 3

ClinicalTrials.gov Identifier:
NCT01260103
“Optic Pathway Glioma”
5% of all childhood tumors

http://www.ncbi.nlm.nih.gov/m/pubmed/22607912

Today is “Rare Disease” Day
http://rarediseases.info.nih.gov/GARD/Condition/4107/Optic_pathway_glioma.aspx

NCT01260103 (BRI-BT-54)
http://www.clinicaltrials.gov/ct2/show/record/NCT01260103?term=Burzynski&rank=61

Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm

Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2

Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066486
BC-BR-12, NCT00003454
http://cancer.gov/clinicaltrials/BC-BR-12

Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003455
CDR0000066487, BC-BR-14
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066488
BRI-BT-7, NCT00003456
http://cancer.gov/clinicaltrials/BRI-BT-7
· Protocol BT-07, involving the study of Antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy

BT-07 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
2 / 8.3% – # and % of Patients Showing Complete Response
1 / 4.2% – # and % of Patients Showing Partial Response
3 / 12.5% – # and % of Patients Showing Stable Disease
18 / 75.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066489
BC-BT-9, NCT00003457
http://cancer.gov/clinicaltrials/BC-BT-9
· Protocol BT-09, involving the study of Antineoplastons A10 and AS2-1 in patients with brain tumors

BT-09 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
4 / 14.3% – # and % of Patients Showing Complete Response
5 / 17.9% – # and % of Patients Showing Partial Response
13 / 46.4% – # and % of Patients Showing Stable Disease
6 / 21.4% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066490
BC-BT-10, NCT00003458
http://cancer.gov/clinicaltrials/BC-BT-10
· Protocol BT-10, involving the study of Antineoplastons A10 and AS2-1 in children with brain tumors

BT-10 – Protocol #
30 – Patients Accrued
22 – Evaluable Patients
3 / 13.6% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
7 / 31.8% – # and % of Patients Showing Stable Disease
11 / 50.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066491
BC-BT-11, NCT00003459
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11, involving the study of Antineoplastons A10 and AS2-1 in patients with brainstem glioma

BT-11 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
5 / 17.9% – # and % of Patients Showing Complete Response
4 / 14.3% – # and % of Patients Showing Partial Response
12 / 42.9% – # and % of Patients Showing Stable Disease
7 / 25.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
· Protocol BT-12, involving the study of Antineoplastons A10 and AS2-1 in children with primitive neuroectodermal tumors (PNET)

BT-12 – Protocol #
13 – Patients Accrued
11 – Evaluable Patients
3 / 27.3% – # and % of Patients Showing Complete Response
1 / 9.1% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in children with low grade astrocytoma, a type of PMBT

BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066505
BC-BT-14, NCT00003469
http://cancer.gov/clinicaltrials/BC-BT-14

Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066507
BC-BT-15, NCT00003470
http://cancer.gov/clinicaltrials/BC-BT-15
· Protocol BT-15, involving the study of Antineoplastons A10 and AS2-1 in adult patients with anaplastic astrocytoma, a type of PMBT

BT-15 – Protocol #
27 – Patients Accrued
20 – Evaluable Patients
3 / 15.0% – # and % of Patients Showing Complete Response
2 / 10.0% – # and % of Patients Showing Partial Response
9 / 45.0% – # and % of Patients Showing Stable Disease
6 / 30.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066508
BC-BT-16, NCT00003471
http://cancer.gov/clinicaltrials/BC-BT-16

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Closed
Age 18 and over
Phase 2
Phase II
CLOSED
Protocol IDs
CDR0000066509
BC-BT-17, NCT00003472
http://cancer.gov/clinicaltrials/BC-BT-17

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066510
BC-BT-18, NCT00003473
http://cancer.gov/clinicaltrials/BC-BT-18
Protocol BT-18, involving a study of Antineoplastons A10 and AS2-1 in the treatment of “mixed glioma,” a type of PMBT

BT-18 – Protocol #
20 – Patients Accrued
13 – Evaluable Patients
3 / 23.1% – # and % of Patients Showing Complete Response
1 / 7.7% – # and % of Patients Showing Partial Response
3 / 23.1% – # and % of Patients Showing Stable Disease
6 / 46.2% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066511
BRI-BT-20, NCT00003474
http://cancer.gov/clinicaltrials/BRI-BT-20
· Protocol BT-20, involving the study of Antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme, which recurred after standard radiation and/or chemotherapy

BT-20 – Protocol #
40 – Patients Accrued
22 – Evaluable Patients
1 / 4.5% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
12/ 54.5% – # and % of Patients Showing Stable Disease
8 / 36.4% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066512
BC-BT-21, NCT00003475
http://cancer.gov/clinicaltrials/BC-BT-21
· Protocol BT-21, involving the study of Antineoplastons A10 and AS2-1 in adults with primary malignant brain tumors

BT-21 – Protocol #
40 – Patients Accrued
23 – Evaluable Patients
2 / 8.7% – # and % of Patients Showing Complete Response
2 / 8.7% – # and % of Patients Showing Partial Response
9 / 39.1% – # and % of Patients Showing Stable Disease
10 / 43.5% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II
Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066513
BC-BT-22, NCT00003476
http://cancer.gov/clinicaltrials/BC-BT-22
· Protocol BT-22, involving a study of Antineoplastons A10 and AS2-1 in children with primary malignant brain tumors

BT-22 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
1 / 4.2% – # and % of Patients Showing Complete Response
3 / 12.5% – # and % of Patients Showing Partial Response
9 / 37.5% – # and % of Patients Showing Stable Disease
11 / 45.8% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Ependymoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066516
BC-BT-24, NCT00003479
http://cancer.gov/clinicaltrials/BC-BT-24

Antineoplaston Therapy in Treating Patients With Meningioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066521
BC-BT-28, NCT00003483
http://cancer.gov/clinicaltrials/BC-BT-28

Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer
Colorectal Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066523
BC-CO-2, NCT00003485
http://cancer.gov/clinicaltrials/BC-CO-2

Antineoplaston Therapy in Treating Patients With Colon Cancer
Stage IV Colon Cancer
Recurrent Colon Cancer
Adenocarcinoma of the Colon
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003486
CDR0000066524, BC-CO-3
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
Esophageal Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
NCT00003487
CDR0000066525, BC-ES-2
THIS STUDY HAS BEEN TERMINATED (Withdrawn due to slow enrollment)

Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Head and Neck Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 16 and over
Protocol IDs
CDR0000066527
BC-HN-2, NCT00003489
http://cancer.gov/clinicaltrials/BC-HN-2

Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Phase 2
Closed
Protocol IDs
CDR0000066530
BC-LA-3, NCT00003491
http://cancer.gov/clinicaltrials/BC-LA-3

Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066531
BC-LA-4, NCT00003492
http://cancer.gov/clinicaltrials/BC-LA-4

Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066533
BC-LA-5, NCT00003494
http://cancer.gov/clinicaltrials/BC-LA-5

Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Age 18 and over
CLOSED
Protocol IDs
CDR0000066534
BC-LA-6, NCT00003495
http://cancer.gov/clinicaltrials/BC-LA-6

Antineoplaston Therapy in Treating Patients With Recurrent or Extensive-Stage Small Cell Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066535
BC-LA-7, NCT00003496
http://cancer.gov/clinicaltrials/BC-LA-7

Antineoplaston Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Closed
Age 18 and over
Phase 2
CLOSED
Protocol IDs
CDR0000066536
BC-LA-10, NCT00003497
http://cancer.gov/clinicaltrials/BC-LA-10

Antineoplaston Therapy in Treating Patients With Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066537
BC-LY-3, NCT00003498
http://cancer.gov/clinicaltrials/BC-LY-3

Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066538
BC-LY-6, NCT00003499
http://cancer.gov/clinicaltrials/BC-LY-6

Antineoplaston Therapy in Treating Patients With Refractory or Recurrent Intermediate-Grade Stage II, Stage III, or Stage IV Non-Hodgkin’s Lymphoma
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066540
BC-LY-7, NCT00003500
http://cancer.gov/clinicaltrials/BC-LY-7

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066541
BC-LY-8, NCT00003501
http://cancer.gov/clinicaltrials/BC-LY-8

Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003502
CDR0000066542, BC-LY-9
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapyuuhnp
Procedure: differentiation therapy
Phase 2
NCT00003505
CDR0000066545, BC-LY-12
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Malignant Mesothelioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
NCT00003508
CDR0000066551, BC-MA-2
THIS STUDY HAS BEEN TERMINATED (Withdrawn due to slow enrollment)

Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509
http://cancer.gov/clinicaltrials/BC-ME-2
COMPLETED

Antineoplaston Therapy in Treating Patients With Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066554
BC-MM-2, NCT00003511
http://cancer.gov/clinicaltrials/BC-MM-2

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066555
BC-MW-2, NCT00003512
http://cancer.gov/clinicaltrials/BC-MW-2

Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory
Neuroblastoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066556
BC-NB-2, NCT00003513
http://cancer.gov/clinicaltrials/BC-NB-2

Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
Merkel Cell Carcinoma
Islet Cell Carcinoma
Neuroendocrine Carcinoma
Pituitary Tumor
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003514
CDR0000066557, BC-NE-2
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
Sarcoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066558
BC-PN-2, NCT00003515
http://cancer.gov/clinicaltrials/BC-PN-2

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066559
BC-PR-5, NCT00003516
http://cancer.gov/clinicaltrials/BC-PR-5

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Adenocarcinoma of the Prostate
Stage III Prostate Cancer
Stage IV Prostate Cancer
Recurrent Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Drug: bicalutamide
Drug: flutamide
Drug: leuprolide acetate
Procedure: alternative product therapy
Procedure: antiandrogen therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Procedure: endocrine therapy
Procedure: hormone therapy
Phase 2
NCT00003517
CDR0000066560, BC-PR-6
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Kidney Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066564
BC-RN-2, NCT00003520
http://cancer.gov/clinicaltrials/BC-RN-2

Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
Sarcoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066565
BC-SA-2, NCT00003521
http://cancer.gov/clinicaltrials/BC-SA-2

Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine
Small Intestine Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066566
BC-SI-2, NCT00003522
http://cancer.gov/clinicaltrials/BC-SI-2

Antineoplaston Therapy in Treating Patients With Stomach Cancer
Gastric Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066568
BC-ST-2, NCT00003524
http://cancer.gov/clinicaltrials/BC-ST-2

Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva
Cervical Cancer
Vulvar Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066569
BC-UC-2, NCT00003525
http://cancer.gov/clinicaltrials/BC-UC-2

Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Carcinoma of Unknown Primary
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066570
BC-UP-2, NCT00003526
http://cancer.gov/clinicaltrials/BC-UP-2

Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Liver Cancer
Drug: antineoplaston A10
Phase 2
Phase II
CLOSED
Age 14 and over
Protocol IDs
CDR0000066577
BC-HE-2, NCT00003530
http://cancer.gov/clinicaltrials/BC-HE-2

Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
Pancreatic Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Protocol IDs
Age 18 and over
CDR0000066578
BC-PA-2, NCT00003531
http://cancer.gov/clinicaltrials/BC-PA-2

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer
Ovarian Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066579
BC-OV-2, NCT00003532
http://cancer.gov/clinicaltrials/BC-OV-2

Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066580
BC-PR-4, NCT00003533
http://cancer.gov/clinicaltrials/BC-PR-4

Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066581
BC-PR-8, NCT00003534
http://cancer.gov/clinicaltrials/BC-PR-8

Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066582
BC-BT-6, NCT00003535
http://cancer.gov/clinicaltrials/BC-BT-6
· Protocol BT-06, involving the study of Antineoplastons A10 and AS2-1 in children with high grade glioma

BT-06 – Protocol #
19 – Patients Accrued
11 – Evaluable Patients
1 / 9.1 % – # and % of Patients Showing Complete Response
3 / 27.3% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease

Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Drug: antineoplaston A10
Drug: methotrexate
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: chemotherapy
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003536
CDR0000066584, BC-BR-10
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Recruiting
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066585
BC-BT-8, NCT00003537
http://cancer.gov/clinicaltrials/BC-BT-8
· Protocol BT-08, involving the study of Antineoplastons A10 and AS2-1 in patients with anaplastic astrocytoma

BT-08 – Protocol #
19 – Patients Accrued
14- Evaluable Patients
4 / 28.6% – # and % of Patients Showing Complete Response
0 / 0.0% – # and % of Patients Showing Partial Response
6 / 42.9% – # and % of Patients Showing Stable Disease
4 / 28.6% – # and % of Patients Showing Progressive Disease

A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma
Optic Nerve Glioma
Drug: Temozolomide
Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
Phase 3
NOT YET RECRUITING
NCT01260103
BRI-BT-54

(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in children with visual pathway glioma)

BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease

2003
recurrent diffuse intrinsic brain stem glioma
Phase 2
phase II
antineoplaston A10 and AS2-1

6 months median duration of treatment

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from the start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003
Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004
incurable recurrent and progressive multicentric glioma
Phase 2
Phase II
antineoplaston A10 and AS2-1 (ANP)
9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

10 patients are alive and well from 2 to >14 years post-diagnosis

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

http://www.secinfo.com/d11MXs.p23hz.htm

8/31/2012 (10/15/2012)
Form 10-Q (Received 10/15/12 • Period 08/31/12)
“The Company believes Antineoplastons are useful in the treatment of human cancer and is currently conducting PHASE II CLINICAL TRIALS of Antineoplastons relating to the treatment of cancer”

11/30/2012 (1/14/2013)
40–Active/Not Recruiting/Closed
Form 10-Q (For the quarterly period ended November 30, 2012) (1/14/2013)
“The Company is currently conducting ONE FDA-approved CLINICAL TRIAL”
http://www.faqs.org/sec-filings/130114/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-Q

Clinical trial costs paid direct
2010 – $4,243,476
FDA clinical trial expenses paid directly by Burzynski
5/31/2010 – $1,230,650
2/28/2010 – $4,243,476
Clinical trial costs paid direct
2009 – $4,678,626
FDA clinical trial expenses paid directly by Burzynski
11/30/2009 – $3,040,367
8/31/2009 – $1,951,248
5/31/2009 – $934,293
2/28/2009 – $4,678,626
11/30/2008 – $3,605,450
8/31/2008 – $2,375,780
5/31/2008- $1,160,297
5/31/2007 – $964,090
5/31/2006 – $978,705
11/30/2005 – $3,070,881
11/30/2004 – $3,128,619
8/31/2002 – $1,741,950
5/31/2002 – $908,639
8/31/2001 – $2,320,149
5/31/2001 – $1,178,965
5/31/2000 – $902,027
5/31/1999 – $1,095,523
3/1/1996 – 2/28/1997 – $532,853 – increase
3/1/1996 – 2/28/1997 – 115.6% – increase mainly due to Company agreeing to pay 20% of cost of chemicals used in Phase II clinical trials conducted by Burzynski

Oh where, oh where, has The 21st Floor gone? Oh where, oh where, can it be?

It appears that The 21st Floor as we know it has disappeared from the blatherblogosphere
http://www.thetwentyfirstfloor.com

The good news, at least when I referred to it I quoted from it and its contents can still be found on the Internet using Google, for example

RIP 21

Finally, James Randi Educational Fund (jref) wins an award that they richly deserve

Bestowed with

“PigASSus”

Award

for ADOLESCENT blog comment VOTE option that “MINIMIZES” comments

#Burzynski

11:02am – 1 Apr 13

http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html