Tag Archives: Phase 2

DJT’s Comments – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

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Yes
Okay
Well as I put in my about page, I agreed with the juror that he was neither guilty or innocent
So, so since I see all this opposition by these Skeptics, and I see that the they’re getting all of their facts straight
I decided to take the position of being a Skeptic Skeptic
In other words I am skeptical of Skeptics who do not fact-check their information before they post it on social media
And since I see ahhh y’all pretty much trying to take over the net with y’all’s information I decided to come back and correct all the false information that was being put out by other Skeptics
Well the major issue is that the FDA’s own information says if phase 3 trials are approved – phase 2 trials is to see if there’s evidence of effectiveness
And so if phase 3 trials are approved, that means you’ve provided evidence of effectiveness
That’s the FDA’s own information – I have that clearly on my blog
Also the FDA has given Burzynski uhhh Orphan Drug Designation in 2004 for uhhh brainstem glioma and then in 2009 for all gliomas
So that must mean that there is evidence of effectiveness, otherwise I don’t think they would be doing that
Well the issue is he was given 2 phase 3 trials that we know of
One was on uh Clinical Trials . gov – the one about eye cancer
The vision cancer
And then the other one was not posted on there, but then again the FDA has said, and I posted this on my blog because I specifically contacted and asked them and they said we don’t post all clinical trials on our web-site
And so he obviously had that other one about brainstem glioma, that he was trying to get started
But the other issue is that Skeptics have posted on there that he could not get that accelerated approval until he had published a phase 2 trial and that is exactly not the case because other drugs have been given accelerated approval before their results were published in phase 2 clinical trial publications, cuz, so that question remains as well
Well, what we do know is that in the movie, Merola showed that one page rejection from The Lancet
where Burzynski was trying to show his results from like 8 to 16 years, and they said we think your uh publication would be seen best elsewhere, or some ridiculous statement like that
And so, I thought that funny of The Lancet
Of course, I understand their 2nd response, which came out, which Eric posted on his Facebook page, y’all, that y’all have talked about – that, you know, they’re busy, they get a lot of
submissions
I understand that, so obviously he would have to look for a different publication for both of those, things he’s trying to get published
Well a lot of the time I’m making fun of y’all’s favorite oncologist, the way he words his blogs, and uhmmm I cite specifically from the FDA, from from the National Cancer Institute, from these other scientific sources, from scientific publications
I give people specific information so they can fact-check me, unlike a lot of The Skeptics who just go out there and say things and publish things on social media, they provide no back-up for their uhhh sayings
And so when I critique an oncologist or any other Skeptic I always provide source material so people can always fact-check me and I specifically said that people should fact-check everything ummm that the oncologist should say because he has, I’ve proven him to be frequently incorrect about his information and misleading
And so I’ve tried to add those things and allow people to search, on specific things like publications, or what I posted about The Lancet, or specifically about The Skeptics, or specifically about the oncologist
So whenever I see something posted new on Twitter, by y’all, sometimes I’ll check it out and sometimes I won’t, and sometimes I’ll comment on it
I was, on there just yesterday to see some more of your post on there
Well the thing is, when you accepted this hangout, I published my newest blog article and I specifically listed all the information I had critiqued from you previously including Amelia, and I posted the specific Twitter responses by BurzynskiMovie; which is probably Eric, to your issues with Amelia, and he disagrees with what the oncologist posted, and so I pretty much let his Twitter responses stand to what the oncologist said
Well I also did a critique of the newspaper story that was put out about Amelia in the U.K.
And they had 2, 2 patients that were dealt with
And
I believe, yes
And one of the patients, Burzynski has specifically published in one of his scientific publications that maximum dosage is not reached for a month
So if someone, so if someone only goes in there and has treatment for a month, they’re not even, you know, they’re finally going to reach the uh maximum dosage
And I think that was maybe the case with Luna, I think she was only there for a month
Well my only thing is, uh, we know that sometimes he will go to a maximum dosage, or you know, the suggested dosage, but he will back down off it, in fact in the uh adverse effects you mentioned those are specifically adverse effects mentioned in his publications, and when that happens normally they will subside within 24 to 48 hours is what it says once you take them off the treatment and let, you know, those conditions take care of themselves, and then you will slowly raise the medication again
So, you know, it just didn’t tell, if only one month of treatment was enough to even start to do anything for her
Well the thing is, the FDA has approved phase 3, and also given them the Orphan Drug Designation, which means they should have some knowledge about what’s going on, I would think
Plus we don’t know for sure, we’ve heard about, ummm, some of the things supposedly the oncologist has talked about, which is cutting off the blood flow, to the tumor, which is something that some uhhh drugs can do, and I think that’s one of the things Burzynski has tried to do, ah he’s specifically mentioned it in his personalized treatment
But I don’t know for sure if it’s also something that’s done with the ANP’s in just the clinical trials environment
So, that could be a possibility
Well
Well what I find interesting about these other doctors is like like the doctors mentioned in the movie and BBC Panorama’s report and in some of these newspaper articles where they are mentioned again is that these doctors never do a review of Burzynski’s scientific publications and including our favorite oncologist who refuses to do so
Uhhh
Oh yeah he says he’s read everything but uh you know he claims that he’s uhmmm reviewed, reviewed uh Burzynski’s personalized gene targeted therapy but he, but then just a few months ago he admitted, you know, I don’t know where Burzynski says which genes are targeted by antineoplastons
And I pointed out which specific publications that Burzynski published, publications which specifically mention which genes are targeted by antineoplastons, and I said how can you claim that you’ve read and reviewed every Burzynski publication and you didn’t know which genes are targeted by antineoplastons when that’s specifically in the publications ?
To me that tells me that you do not know how antineoplastons work be because you just admitted you don’t know which genes Burzynski talks about
I mean that’s just funny as heck to me that he would say that
Well I’ve, I’ve got it on my blog
Uhm
I mean I can forward it to you at some point
But I agree with you about I don’t remember seeing anything about antineoplastons cutting off the blood flow to the, you know the blood brain barrier for sure either
Well I think I know the point that you’re getting at uhhh about the IRB’s and all that good stuff
All I can say is that, you know the FDA can come in with any amount of investigators and say that you did this or that but you have the opportunity to respond, and so they can pretty much say anything, it’s only when the final report comes out that you can take that to the bank
And so all this speculation about what a investigative team may say about the clinic is, to me just like someone going into a lawsuit and saying so-and-so did this, you know, can you prove that, you know, did so-and-so do that
So it’s the same thing with the FDA, these um little reports, the final report is what counts, and so, also what I find interesting is some of Burzynski’s publications specifically said, you know this particular uh clinical trial, the IRB was agreed upon by the FDA
Well if if the FDA agreed upon it, you know, then some questions should arise about exactly what did the FDA agree upon
What would we find out from a Freedom of Information Act request on that ?
And, and what I also found interesting is when I did research on other clinical trials for brainstem glioma I found, you know, all these other science based medicine studies where 374 children had died in their studies
And what I found interesting is back in 1999, they reported on a clinical trial, they had better results then all these clinical trials afterwards
Well, I would have to find you one, there were like 3
There were like 3 major ones that Burzynski has mentioned in his publications to cross-reference his trials versus their trials as far as the results
And so, I, there was one back in 1999 that had better results than a lot of these clinical trials that come afterwards
So when we talk about, you know, what’s really right for the patients well we can see that the drug companies want to test their drugs through clinical trials and, you know, and if your kid dies, well, unfortunately the kid dies
Even though we showed better results in 1999 with a different type of treatment, you would have thought that maybe they would have poured more investment into that particular treatment but that’s not necessarily how the clinical trial system works
Well here’s my point, I mean, y’all probably get a better sense from, ummm, Hymas, about what’s going on with that
From her uh fiancé, or husband, whatever his status happens to be right now
And uh also from Ric, uh they’re more closer to Burzynski than I am, because I have never met Burzynski, I have never e-mailed Burzynski, uhmmm never talked to Burzynski, never met him, blah blah blah
Uh, my sense is that since 1996 when the FDA talked about antineoplastons, that specific FDA Commissioner that was in charge at the time, he set out 7 major points about how there was going to be less people required and there was going to be less paperwork, there was going to be less stringent things about Partial Response
And so, to me, the FDA is the final source to go to when people want to complain about how long their trials have lasted uh because the FDA is bottom line, you know, in charge of that
And
And my other point is that, uhmmm, when these trials finish, as I’ve pointed out on my blog, M.D. Anderson finished a trial in 2006 and didn’t publish the results electronically until January of this year
So, just think
Burzynski’s 1st trial we know that finished in 2009
So we would still have more years to go before he caught up to M.D. Anderson as far as publishing
So for him to actually be trying to publish stuff now and The Lancet not publishing because they have other stuff to do, put in there, that’s understandable
So, we know that he’s trying to publish, uh but they’re going to keep it close to the vest obviously, from, from how they do their things, and where they’re trying to publish
And plus, like I’ve said before
We’ve still got the accelerated approval thing that’s out there, you know, like the FDA’s given Temodar and, and Avastin, and another drug, whereas they’re not doing the same thing for antineoplastons, eve even though for all intents and purposes from what we know, antineoplastons have had better success rates than Temodar and Avastin when they were approved
Well from the information that’s been published in certain um publications
And in, and in not only Burzynski’s but elsewhere in, in newspapers or articles, or such like that
Well what I found interesting is when the FDA approved these other 1 or 2 drugs, some of them specifically said that, uhhh, some of these drugs had, you know, better survivability or they showed no better rate than any previous treatment but we’re approving it anyway
Basically that’s what the publication said and I published this on my blog in an article specifically about, you know, those 2 or 3 drugs that the FDA approved for brainstem or brain related cancers
And so, you know, I’m not going to buy that argument about that, about that specific thing
Well one of these newspaper articles specifically said, you know, Avastin would maybe keep you alive for maybe 4 more months
So, you know, take that
Well, we can wonder if some of Burzynski’s results are the same, otherwise why would the FDA say, you know, give the ODD, why would the FDA give the phase 3 approval
Plus I don’t buy some of these doctors coming out and saying stuff, they have the opportunity just like the other doctors in Egypt, in Russia, in Germany, in, in Poland in China in Taiwan that have done antineoplaston studies, I’m like, these people can do antineoplaston studies so what’s the excuse for all these other doctors who say that they supposedly can’t do them
You know, the information’s out there and
and like these other doctors can do it
Well, we kind of know that that’s a fact
Well what we know from 1996 from Burzynski’s own information that he’s published, is that not only does he have the original parent antineoplastons, but he’s developed 2nd and 3rd generations, but he can’t just stop in the middle of his clinical trial and use the 2nd and 3rd generations which may be better
He can’t uh use these other types of um antineoplastons that other researchers, researchers like Egypt, or Japan have found um that may be better because he can’t just switch in the middle of the clinical trial
Now if he, if the FDA approves his product, well then, maybe he can roll out the 2nd and 3rd generation and these other types of antineoplastons that may be less harsh, but that’s all he’s got to work on and that takes us back to the FDA, having control over the entire process, as far as the paperwork, how many people are in the trials, etcetera
Right
Well I find it interesting that you talk about the cost, because I’ve done a lot of research about the cost, and I was just looking at the cost again this morning, and put it into that particular blog article I was talking about, that I did for this particular program
And, um
The thing that’s funny is that people can say, ohhh Burzynski charges a lot, but the fact is, so does chemo, radiation, and some of these newspaper articles that have been published, and specifically in the movie, Burzynski 2, one of the people mentioned how much someone was paying for standard treatment
And I noticed our
favorite oncologist didn’t comment about that in his movie review
Well what I find interesting, you know, I’m not sure how people think he’s supposed to pay for the clinical trials, you know, if he’s supposed to go into debt, millions of dollars
I find that funny considering the FDA approved phase 3, has given him ODD for brainstem glioma and also also all gliomas
You know, that’s kind of ridiculous
And the people
gettin’ off about his house, well who cares ?
They don’t know where his money came for that particular source
Well, you know, when you have good tax lawyers your tax lawyers will tell you how to structure things, and everybody in America has the right to structure their taxes in a manner that effectively serves them according to our Supreme Court
So, if you have a tax lawyer who tells you, hey this is the best way to do it, to save money, well, you may do that uh based upon your lawyer’s advice
So, maybe Burzynski has taken his tax lawyers advice, just like I’m sure he’s taken Richard Jaffe’s ad advice (laugh), which has proved well, for him
You know, you know
That’s another thing
Well I guess we could ask, you know, Ben and Laura Hymas
What was their experience, you know ?
Did they have, did she have to drink uh a lot of water because she was thirsty ?
You know, did she have to drink a lot of water due to the high sodium ?
So I would ask her about her personal experience instead of saying, you know, instead of quoting some of these other people
Well we all know the FDA is in charge of this, and so hopefully they know what’s going on
No, I’m sure the FDA can look at the records because Burzynski sent them 2.5 million pages according to our friend Fabio
And uh, you know just something the doctors who came in and did the little ol’ one day, 6 patient records, where they reviewed all the records and slides, and MRI’s, etcetera, you know they can do the same thing, the FDA can do the same thing with all these patients
And see the same MRI’s and scans, etcetera
I mean, we, we know that with all these 374 children I mentioned dying in other science-based medicine clinical trials
I mean, they, FDA probably went through all their records
And, so, all these people didn’t look good either but, you know, the FDA still gave approval to Avastin and Te Temodar even though a lot of people died in their clinical trials
I mean, we could agree that since
Burzynski’s publication says that it’s going to take a month to get up to required dosage, and so we know, the tumor can still grow, like he said, up to 50%, he specifically acknowledges that in his publication, so, we know that can happen
Well we know from his own publications, he says he can’t just go in and start giving the maximum dose, or recommended dose right off the bat because a particular condition will occur, and he specifically mentions, in the publications what that condition is, I don’t remember it right off the top of my head
But then again, his 2nd generation, his 3rd generation, his other form of antineoplastons that may work in the future, if approved, well those could possibly have the same uh adverse effects that the current parent generation have
But we don’t know, and like I said the FDA I’m sure knows because they have all the records, we don’t have them, and so unlike our favorite oncologist I’m not going to speculate, about what the FDA knows and I do not know
Well we know they stopped this particular trial, supposedly because a patient died
So what’s the hold-up ?
I mean, hopefully they’ve done an autopsy
What was found
No
And we don’t have a final report from the FDA on what the findings wer
I don’t remember specifically
Possibly not
Well he’s using the same 1st generation drug
Well I’m sure a lot of people leave the doctors office not knowing things, for decades
Well we know the contin, the tumors can uh continue to grow for awhile, at least, and certain effects that they probably would
Well I’m sure, I mean, it’s going to continue to grow, in any other clinical trial too, for a certain awhile
I mean like
Well we know that all these other kids died in these science-based medicine trials, and, you know, we can assume that that was the case there too
The FDA not giving him phase 3 approval, the FDA not giving him ODD designation
And showing that, and showing the FDA that there’s evidence of effectiveness
Not until the FDA says it doesn’t work
Well they seem to be doing a good job at it
Well I’m sure, I’m sure they wouldn’t have done things if they didn’t see some evidence that it was working
No I haven’t read it
I know what it’s called
Right
Well I’m just gonna say, you know, the F, the FDA doing what they’ve done, since they approved those 72 initial trials, pretty much speaks for itself
I mean they’ve had every opportunity to shut this down, since then
No, I’m just concentrating on what we’re doing
Well #1 I don’t think the one with brainstem glioma where they wanted to use radiation with ANP was really the right way to go, I mean he’s already proven that uh he seems to have better results without
first starting radiation
Yeah but the thing is radi, I, the FDA was not saying, ok, one study, one side of the study we’re only going to use ANP, in the other side of the study we’re going to use radiation and and ANP like like they would normally do
No, they wanted to make him use radiation in both sides of the study
They don’t do that with other drugs
Well I don’t buy anything Guy Chapman sells, considering his past record
Well his theories are suspect, anything he hands out, let me tell ya
But the question may be bogus, because of where the messenger has been bogus a lot of times before
Well I’m just gonna say what I think about Chapman because he’s proven himself, many times to be questionable
I don’t see him on my blog responding to my criticism
That’s like, that’s like saying that Gorski’s web-site is disorganized, his blog is like anti vaccine one day, Burzynski the next, blah blah blah
Well how would I know ?
I don’t have
Well you didn’t when I tried to get you to do stuff the 1st time, did ya ?
Well I, the most, the mostly, excuse me, the most recent article I posted on there is the one about this particular conversation, where I went through all your comments that you had posted, and my response to them
And so I tried to consolidate everything into one, particular article
And that’s the newest article
Well I thought that was pretty funny because doing biblical research, you come upon, Didymus Judas Thomas, or he’s all, also known by other names
He’s basically The Skeptic
And so, like I said, I consider myself to be Skeptic of The Skeptics
I thought it was apropos
Of course
I’m doubting The Skeptics
Exactly
Exactly
Well I like how The Skeptics say, you know, all of Burzynski’s successes over the years are anecdotal and uh I consider on the same way that everything negative about Burzynski is anecdotal
Well my point is he’s proven them to the FDA because they’re the ones
Could be, but I would have to read, read the
Well when it comes to Guy Chapman, yeah
You still there ?
Yeah, something cut off there for awhile
Well I would certainly look at that, but then again I would also look at the FDA granting him Orphan Drug Designation
Orphan Drug for brainstem glioma and all gliomas
Right, it’s both AS10 AS2-1 and AS
Well not really, since you mentioned that you’d go in and look at my most recent article, anything you show in there or any reply you give is going to cover, what we’ve gone over
And so we can re debate it there
Well I’ve specifically stated on my blog that Marc Stephens uh obviously didn’t know what he was doing and went about it the wrong way
My position was he should of bou, got around it, gone about it the way I did, which is, I blog, and show where Rhys is wrong, I blog and show where Gorski is wrong, I blog and show where you are wrong, or Josephine Jones, or Guy Chapman, etcetera
And, eh, y’all have every opportunity to come on my blog, and I’ve had very few takers, uh, one claiming to be from Wikipedia, who I shot down
And hasn’t come back
So, you know, I am welcome to anybody trying to come on my blog, and prove what I posted is wrong, and debate anything
Unlike some of The Skeptics I don’t block people on my blog
I don’t give lame reasons for blocking people on my blog because I’m an American and I actually believe in “Free Speech”
Well to me it is when Forbes removes all my comments, in response to Skeptics some, and I showed this from screen-shots
You know, stuff like that
Oh no
It wasn’t down-voted
They, I mean I’ve got screen-shots of where my comments were there, between other people’s comments, and uh, and they just decided to remove all my comments, and I blogged specifically about, you know, what they did and, uh, Gorski’s good friend and pal who authored that particular article
So I, I like how The Skeptics run things, you know
Well I think that people who really believe in “Free Speech,” and when it’s done rationally, I mean, Gorski would never, really respond to any of my questions, so I
Well I know that he specifically removed a review I did uh of his review of Burzynski I on his web, on his blog
But he’s pretty much left a lot of my comments up that I’ve seen
Uh, but he never really responded to my questions about, what he based his beliefs upon
Well I would think, if you’re going to base your position on a certain thing, and then you can’t back it up with scientific literature, uh, you should answer, maybe not specifically to me, but answer the question
Answer to your readers
You know, I can tell his readers come on my blog because it shows that they come on my blog
Well the reason I have so many Twitter things is because, obviously, some of The Skeptics will be on there lying about some tweet I sent, and so Wikipedia, excuse me Twitter will do a little ol’, do their little, hey we’re going to block your account while we do blah blah blah, and I’m not gonna waste my time, going through their little review process, I’ll just create another uh Twitter address because, like, you know, if you read the Twitter information you can have a ridiculous amount of uh Twitter I.D.’s, and I’ll just use another Twitter I.D. and continue on
And so Wikipedia can say what they want, because I’ve only ever used one I.P., I’ve only got on there during one time, and when they finally said hey, you know, we’re not gonna uh grant your appeal, I completely left their web-site alone, so all that stuff
that they post
Yep
So all that garbage that they posted about me, about how I supposedly got on-line, on these other articles is just entirely B.S.
And if they can prove otherwise, I’d sure like to see it
But that’s what y’all always say
That’s what y’all like to say, about everything
Yeah I’m sure that’s what they like to say
I mean, you can report an e-mail, or report a twit, and they’ll block it
But um they’ll never come back and say, and this is why we blocked you, for this particular twit, for this particular reason
Wikipedia is a joke
Oh sure, I’m sure, that’s no problem
I don’t have any problem with them locking that
You know, I could tell when I was on there, and when Merola was on there, because he had a different I.P. address than me, I could tell they were his questions because of the way they were formed
So I said, well they’re not answering his questions, I’ll just take on that role, and uh ask his questions and ask further questions, and they didn’t wanna deal with it, you know
Expose them for what ?
For doing what they do, which is basically provide false information and one-sided information ?
Oh, please
They get on there and they say hey, Lola Quinlan filed a lawsuit, but they don’t tell you anything else
They don’t tell you, you know, Jaffe’s side of the story, and her lawyer’s side of the story
Oh Jaffe’s on there but on that specific article about Lola, they didn’t say, here’s the article that was posted on uh Lola’s attorney’s web-site that, that mentions both his responses and Jaffe’s responses, to the uh lawsuit
Uh, trust me, I tried to add that and they wouldn’t add it
You know, The Skeptics like to be nasty, and so, I’ve been like Josephine Jones
If she wants to play anonymous, I’ll play anonymous
Well, I don’t threaten people
I don’t threaten Gorski
I don’t send letters to people’s employers
I deal with them directly, and, you know, if if they won’t answer questions, then, you know, I’ll just post them on my blog for other people to see, and question uh themselves
Like I said, I’m going to be like Josephine Jones
Because I’ve said so
I’m not even in Texas
I was born in Texas, but I don’t live in Texas
I don’t even, didn’t even, uh live in Houston
Wasn’t even close to Houston
Oh, of course, I, I’ve seen a lot of stuff goes on Twitter
I’ve see y’all saying “Oh, we’re “The Skeptics” and y’all know are names,” but, there’s a lot of Skeptics that post on there with pseudonyms, also
Well, I’m just not sure how some of these uh Skeptics will react considering their past behavior
I mean, when Skeptics refuse to, I mean they block you on your blogs
They block your comments
You know, they decide, “Well, I’m maybe going to accept one comment from you, but I won’t accept anymore
You know, to me that’s just ridiculous
Uh, the action on Forbes that happened, the action on The Guardian that happened, where, you know, you had someone on Gorski’s blog basically lie to the Gua, to The Guardian to get them to get them to uh block my comment
So, you know, I’m Skeptical of The Skeptics and their uh and what they would do
Not really
I like my anonymity just like Josephine Jones likes hers
I mean, I will read her stuff and reply to it and treat it seriously jus, just like any other blogger
Well the thing is, some of these Skeptics use names, and they’re not necessarily their real names
So, you know, I’ve seen
Well I think that some people just have bad manners
I mean see, I’ve seen Skeptics on Twitter basically harass someone pro-Burzynski and keep sending them tweets, and that person specifically send them a tweet saying please keep, stop sending me tweets
You know, they didn’t go in and ask Twitter to block the, that particular person
That person just kept sending them tweets
So, you know, I’ve seen that stuff before
Yeah, I’ll look at it, and if you notice, I don’t uh, I usually don’t reply to Skeptics individually because I pretty much figure that y’all are gonna try and get my next account blocked whenever I do that kind of junk, so, well, you know, I just post what I want to post, under the Hashtag
Well I’ll just keep reviewing the, any inaccurate statements I see posted
You know, it depends on if it’s Gorski, you know
Gorski’s gone on there and posted inaccurate stuff, and I call him out, you know he’s basically said on his blog, you know, if I do something inaccurate, you know, I’ll ‘fess up to it
Well, I’ve pointed out where he’s done that and said “Hey, you said you were gonna ‘fess up to it”
If I said on my blog that I was going to ‘fess up to doing something wrong, and you caught me, well, then I should, come out and say, “Okay, you got me”
But Gorski won’t even do that, you know, he just continues to go on down the road, as if
I mean one of the
excuse
I find, I find
You know, I’m just going to let the FDA do their job, and let y’all speculate all y’all want
Uh, I mean
See, I’m here for full discussion
And y’all don’t seem to want to discuss, after y’all just go out there and spam the Internet with garbage, that you don’t back-up with citations and references and links
But some of your other stuff that you tweeted that you haven’t backed up with links, and some of the stuff on thehoustoncancerquack isn’t backed-up with links, and Gorski’s stuff
Well, that and the anp4all one
isn’t backed up
When the FDA says he’s wrong
I mean, I’m not, I’m not just gonna accept your story
Burzynski provides the FDA with the evidence, and the FDA makes the
the FDA doesn’t approve a drug
if something’s not proved
Well you know that he’s trying
I mean, y’all can sit there and jump up and down all you want
Well, I’m gonna go with what the FDA is gonna do still because they’re running the show
What I find funny is that y’all complain, “Well, he hasn’t published, uh a final report”
Well his 1st final, was completed in 2009, and like I said, the M.D. Anderson 2006 study wasn’t published until 2, 2013
I mean, so y’all can jump up and down all you want
Y’all want a final report
Well, the final report will be done when the clinical trial is over
Well, unless you’re The Lancet, I guess
Well, I’m not gonna get into speculation, I’m just going to wait and see
Well how have I been speculating ?
what the journals keep saying, in response
You know, are they going to give The Lancet response, like they did in 2 hours and such, saying, “Well, we think your message would be best heard elsewhere,” or they gonna gonna give The Lancet response of, “Well, we don’t have room in our publication this time, well, because we’re full up, so, try and pick another place
Well, you like to jump up and down with the 15 year quote, but then again I always get back to, Hey, it’s when, when the report, when the clinical trial is done
Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
The FDA A believes there is evidence of efficacy
Well, we don’t know that
We don’t have the Freedom of Information Act information
Well, we know what happened in the movie because Eric particularly covered that when they tried to get what, what, was it 200 or 300 something institutions to take on a phase 3, and they refused
Well, Eric gave the reasons that they said they would not take a particular uh phase 3
And so using that excuse that you you just gave there, I’m not even gonna buy that one, because that’s not one of the reasons
Eric said they gave
Well I’m
Well, I’m, I’m sure that they’re going to keep you appraised just like they have in the past, just like Eric has done in the past
So
I mean, we’ll see what happens with the Japanese publication
Well that’s like me asking “How long is it going to take for y’all’s, y’all’s Skeptics to respond to my questions ?”
Because y’all haven’t been forthcoming
Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it
Well, y’all are free to, you know, claim that all you want, because I don’t always agree with Eric, and uh, he’s free to express his opinion
Well I don’t necessarily believe, what Eric would say about, you know, The Lancet that refused to publish the 2nd one, for the reasons he stated, and which y’all have commented on, including Gorski
You know, I don’t necessarily agree with that
I am more agreeable to y’all, saying that, you know, they’re busy, they’ve got other things to do, but I’m kind of still laughing at their 1st response which he showed in the movie about how they felt about, you know his results would be better in some other publication
I thought that was kind of a ridiculous response to give someone
Well you would think that if its a form letter they would use the same form that they used the 2nd time
You know, they didn’t use the same wording that they used the 1st time
I would have think that, you know, their 2nd comment
Nah, I’m not saying that they did that all
I’m just sayin’, you know, that they gave, 2 different responses, and I would think that the 2nd one they gave
Well I find it funny, something along the lines of, you know, “We believe your message would be received better elsewhere,” you know
I don’t see that as a normal response, a scientific publication would send to someone trying to publish something
I mean, to me that sounds, like, if you’re doing that, and you’re The Lancet Oncology, maybe you need to set some different procedures in place, ‘cuz you would think that with such a great scientific peer-reviewed magazine, that they would have structured things in as far as how they do their operations
Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynski should publish
Like I said before
Like I said before on my blog, you know, even if Burzynski publishes his phase 2 information, Gorski can just jump up and down and say, “Well, that just shows evidence of efficacy, you know, it’s not phase 3, so it doesn’t really prove it”
So then he can go on, you know, for however many years he wants to
Well,
This is, this is a guy who must phone it in because, he went in there and posted the old Josephine Jones response that, you know, no drugs had been approved by the FDA without their final phase 2 publication 1st being published, which was not a factual statement, and you’ve made the same statement
So I, I’m thinking that Gorski just bought her statement and took it and ran with it, and before he fact-checked it, and what, what happened, it was wrong
I mean, Gorski needs to stop phoning stuff in, and check his sources before he posts stuff, because I’ve found many cases where, he hasn’t seemed to do that, and that’s why I question him
Well, I found it interesting that uh the one on the, Burzynski 2, you know he gave his ex excuses for not, working with uh, that patient, and, but yet, he was the same doctor that treated a another Burzynski patient, according to the movie
I mean, so what does he do ?
Pick and choose ?
Or do doctors pick and choose over there in Britain ?
Well, the movie didn’t say anything
Well, I fail to see these doctors on there, providing any factual information, anywhere on the Internet about, uh their disagreements, in a serious way, instead of just making these over-broad statements, you know, “He hasn’t published anything in the blah blah blah,” and
Well, he’s provided some data, and specifically 4 publications
He’s given more than the case studies
He’s done more than the case studies
He’s specifically given uh, almost all the information om an oncologist would want
And Gorski, and Gorski
I mean, I love Gorski, but he comes up with these stupid excuses like, “Well, Burzynski is not an oncologist”
Well, Gorski doesn’t go go in there and look at his other, his phase 2 clinical trial publications, as far as the preliminary reports, and look at the co-authors, and see if any of those guys are oncologists, and that they’re working with Gorski, I mean they’re working with Burzynski
I find that ridiculous
Well y’all, y’all can call things what y’all want
I mean, y’all can give these, fallacy arguments and all that garbage that y’all like, because that’s what y’all like to talk about instead of dealing with the issues
I mean, Gorski doesn’t want to deal with the issues
Hey, I’ve said it to Gorski
He liked to back his stuff up on the Mayo study, yet he wouldn’t, he wouldn’t uh debate about the Mayo study
He likes to say, “Well, Burzynski is not an oncologist,” but he won’t, say Hey, look at the publications, are any of the guys on the publications oncologists ?
We know that Gorski, we know that Burzynski works with oncologists in his practice
So, just because Burzynski himself is not an an oncologist, does not necessarily mean anything
Do we need to go out, onto PubMed, and, and review every particular person that’s published something about cancer and see if they’re all oncologists ?
Seriously
I mean, Gorski will just
post a lot of stuff without backing it up
Well, I, you know, that’s up to someone’s opinion, considering some of the information that’s that the FDA has accepted, as far as giving these guys approval
How did I say I, I didn’t trust them ?
Well, I didn’t say that they weren’t trustworthy, I just raised questions that no one wants to answer about ‘em
No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em
Well, to me the FDA owes Burzynski for a lot of the garbage they pulled off against him (laugh), not to say, you know, they owe him in that way, but they owed him
Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution
I mean
Right
Well I find it interesting a lot of this uh, a lot of these letters that were provided between, you know, the government and Burzynski, when the uh phase 2 study was going on, at the behest of the NCI
You know, anybody who reads that stuff knows, that when just ignore the person that’s been doing, do treating their patients for 20 something years, or close to 20 years, and you change the protocol without his approval, and you don’t use the drugs in the manner that he knows works
Well, he says they work together and they’re not going to work if you don’t use them that way
Why would he leave the country ?
I think he’s made it clear
Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
So I can say that since the Mayo Clinic finished their study in 2006, and it took them until 2013, to actually publish it, then I can say, well, Burzynski finished his in 2009, which was 3 years later, which would give Burzynski until 2016
for me to make up my mind
Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo to publish their study; which was from 2006 to 2013
How do you know it was delayed ?
I mean, has anybody
done a review of when a clinical trial is studied, and completed, and how long it took the people to publish it ?
You know
If they could point to me a study that’s done that, and say, well here’s the high end, here’s the low end of the spectrum, here’s the middle
Sure
Sure, but that’s not gonna, you know like, answer an overall question of, you know, somebody did a comparative study of all clinical trials, and, when they were finished, and at, and when the study was actually published afterwards
You know, that’s only gonna be one, particular clinical study
Well, we know that the Declaration of Helsinki doesn’t even give a standard saying, “You must publish within x amount of years,” you know ?
So, I’ve yet to find a Skeptic who posted something that said, “Here are the standards, published here”
Again, we get back to, when the clinical trial is finished, not when Burzynski started
I mean, you would expect to find a results to be published after, the final results are in
You would expect some people would want to have confidentiality, and maybe not want to be included
Why am I unsure ?
I just gave you an example
Oh, who said I was unsure ?
I just gave you an example
I mean, I’m just, I believe in free and open debate
I mean, I believe, if y’all are gonna spam the Internet, the Internet with garbage that y’all do not back-up, with specific
references
Like your tweet that said uh, “antineoplastons is uron, is Unicorn pee,” right ?
“Burzynski is a vampire”
Good one
He sucks their blood out of ‘em right ?
Yeah
Humor
Okay, I understand humor
Well, that’s because he’s Polish
What I defend, is that, y’all post stuff, a lot of Skeptics post stuff, including Gorski, and they do not back it up, with references, citations, or links
Gorski will just post stuff, like he did about saying, you know, the FDA would not approve, uh, accelerated approval, without a final phase 2 clinical trial being published, which was an incorrect statement, he did not provide any link
We know it’s false
Well, I’m just
I’m just
Not
That’s
Well, that is just lame
Y’all, Skeptics, like to sh spam Twitter, and social media, with all this negative stuff about Burzynski, but then when I ask you to back it up, you can’t back it up, and then, and then on this conversation you want to come down and pinhole it, to a specific subject, you know, the nitty-gritty
Well, if y’all were only debating the nitty-gritty, we would only be d debating the nitty-gritty, but that’s not what y’all do
Well, we know the FDA’s said there is
And I’ll give you those links that I told you I would give you
Yeah, that’s fine
Well, I thought it was productive too
You know, I don’t see why Gorski is afraid of debating issues
on the Internet, on his blog
Hey, he has time to post about, “Hey, uh, Burzynski got a Catholic award from somebody,” which, has nothing to do with antineoplastons, whatsoever
So, you know, he’s not focusing just in on, “Do antineoplastons work, yes or no?,” “When will Burzynski publish ?,” yes or no ?
You know, he’s putting all this ridiculous side junk, you know
So, I am not going to take that seriously
Exactly
You bet
Thank you
You too

Burzynski: The Clinical Trials

Posted on by
Reply

(Being added to)

clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:
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50 – Unknown
7 – Withdrawn
2 – Terminated
1 – Not yet recruiting
1 – Completed
61 – TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Completed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
61 – TOTAL
� � � � � � � � � � � � � � � � �
Below 1 st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
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Below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
� � � � � � � � � � � � � � � � �
1 – Completed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
9=WITHDRAWN
1 – Not Yet Recruiting (Open)
10 – Recruiting (Open)
11=OPEN (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
61 – TOTAL
� � � � � � � � � � � � � � � � �
1=COMPLETED
9=WITHDRAWN
11=OPEN
40=CLOSED
61-TOTAL
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The “one” COMPLETED trial:

The below 2nd link: 25 Closed-1st screen / 15 Closed-1 COMPLETED-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Phase: Phase II
Type: Treatment
Status: COMPLETED
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066552, BC-ME-2, NCT00003509
http://clinicaltrials.gov/ct2/results?term=&recr=Completed&rslt=&type=&cond=&intr=&titles=&outc=&spons=&lead=Burzynski+&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&phase=1&rcv_s=&rcv_e=&lup_s=&lup_e=
COMPLETED

Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

Condition: Melanoma (Skin)

Interventions:

Drug: antineoplaston A10
Drug: antineoplaston AS2-1

1 study: Melanoma
1 study: Neoplasms, Germ Cell and Embryonal
1 study: Neoplasms, Nerve Tissue
1 study: Neuroectodermal Tumors
1 study: Neuroendocrine Tumors
1 study: Neuroepithelioma
1 study: Nevus
1 study: Nevus, Pigmented

1 study found, shown on map

Region Number of
Name Studies
World 1
North America 1
United States [map] 1 [studies]

Found 1 study with search of:

COMPLETED | Burzynski [Lead] | Phase 2

Recognized Terms and Synonyms:
burzynski: 61 studies
http://clinicaltrials.gov/ct2/show/NCT00003509?recr=Completed&lead=Burzynski&phase=1&rank=1
Trial record 1 of 1 for:

COMPLETED | Burzynski [Lead] | Phase 2

Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

This study has been COMPLETED

Sponsor: Burzynski Research Institute

Information provided by:
National Cancer Institute (NCI)

ClinicalTrials.gov Identifier: NCT00003509

11/1/1999 – First received

5/23/2009 – Last updated

5/2009 – Last verified
http://clinicaltrials.gov/ct2/archive/NCT00003509
Securities and Exchange Commission (SEC) filings “one” COMPLETED trial:

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
Certain prospective protocols which have reached a Milestone as of May 1, 2012

Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509
http://cancer.gov/clinicaltrials/BC-ME-2
2009_05_26 Study Changes Recruitment status, Recruitment, Misc.
1 clinical_study study_id
2
is_fda_regulated Yes
is_section_801 Yes
delayed_posting No
resp_party name_title Stanislaw R. Burzynski
name_title organization Burzynski Clinic
organization resp_party

Fm: Active, not recruiting
To: COMPLETED

status date
Fm: 2008-04
To: 2009-05

date
Fm: 2008-01
To: 2005-02

last_release_date
Fm: 2008-07-23
To: 2009-05-23
http://clinicaltrials.gov/archive/NCT00003509/2009_05_26/changes
So, we know the “COMPLETED” date is:

2009-05-23 (5/23/2009)

To put this in perspective, the below study done in 2006, was NOT published until about 7 years later, in 2013

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center
http://www.ncbi.nlm.nih.gov/pubmed/23404230
Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

Department of General Internal Medicine, University of Texas MD Anderson Cancer Center

Division of Endocrinology, Mayo Clinic

Support Care Cancer. 2013 Feb 13. [Epub ahead of print]

Supportive Care in Cancer
February 2013

DOI
10.1007/s00520-013-1734-6
http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
� � � � � � � � � � � � � � � � �
Let’s look at “FACTS” which are supported by citation(s), reference(s), and / or link(s)
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting
(OPEN)(Phase 3)
1 – COMPLETED
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
10 – Recruiting
(10=OPEN)
40 – Active, not recruiting –
(40=CLOSED)
61 =TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
40 – Active, not recruiting –
(40=CLOSED)
(1=COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
(9=WITHDRAWN)
25 CLOSED +15 CLOSED –
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
40 – Active, not recruiting
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
11 – OPEN (ACTIVE)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
= 9 WITHDRAWN
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting
(1=OPEN)(Phase 3)
10 – Recruiting
(10=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
� � � � � � � � � � � � � � � � �
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453

2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457

3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458

4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468

5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470

6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473

7. Antineoplaston Therapy in Treating PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475

8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476

9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477

10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
� � � � � � � � � � � � � � � � �
Securities and Exchange Commission (SEC) filings 10 “ACTIVE” (OPEN) trials:

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing
� � � � � � � � � � � � � � � � �
1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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
� � � � � � � � � � � � � � � � �
1. – 10. (2) CONSOLIDATED:
� � � � � � � � � � � � � � � � �
1. 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
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453

2. 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
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457

3. 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
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458

4. 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
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468

5. 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
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470

6. 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
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473

7. 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
7. Antineoplaston Therapy in Treating PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475

8. 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
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476

9. 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
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477

10. 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
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
� � � � � � � � � � � � � � � � �
Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
Certain prospective protocols which have reached a Milestone as of May 1, 2012

The results of Protocols

10. BT-08
2. BT-09
3. BT-10
4. BT-13
5. BT-15
6. BT-18
7. BT-21
8. BT-22
9. BT-23

5/1/2012 – set forth below

1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

3. Antineoplaston Therapy in Treating CHILDREN WITH 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
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

4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
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
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

5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

6. 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 II / Phase 2
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

7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

8. 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

9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· 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

10. 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 II / Phase 2
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
� � � � � � � � � � � � � � � � �
1. – 10. (3) CONSOLIDATED:
� � � � � � � � � � � � � � � � �
1. 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
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
2. 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
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

3. 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
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458
3. Antineoplaston Therapy in Treating CHILDREN WITH 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
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

4. 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
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
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
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

5. 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
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

6. 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
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473
6. 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 II / Phase 2
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

7. 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
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

8. 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
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476
8. 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

9. 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
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· 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

10. 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
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
10. 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 II / Phase 2
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
� � � � � � � � � � � � � � � � �
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

16. 2003

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

BT-11

BRAIN STEM GLIOMA

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/pubmed/12718563
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
6 months – median duration: treatment

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 observed:
3 – skin allergy
2 – anaemia
2 – fever
2 – hypernatremia
1 – agranulocytosis
1 – hypoglycaemia
1 – numbness
1 – tiredness
1 – myalgia
1 – 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
� � � � � � � � � � � � � � � � �
RECURRENT DIFFUSE INTRINSIC BRAIN STEM GLIOMA

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
10/1997 – clinical trials reached Milestone

Clinical Trial BT-11

trial of Clinical Trial BT-11 involves patients with BRAIN STEM GLIOMA

5/1996 – trial approved by FDA

10/1997 – Protocol – BRAIN STEM GLIOMA
12 – Patients Accrued
12 – Evaluable Patients
1 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
8 / 50% – # and % of Patients Showing Stable Disease or Progressive Disease

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
� � � � � � � � � � � � � � � � �
5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-11

5/1/2012 – set forth below

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
RECURRENT DIFFUSE INTRINSIC BRAIN STEM GLIOMA

Antineoplaston Therapy in Treating Patients With BRAIN STEM GLIOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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
� � � � � � � � � � � � � � � � �
BT-11 (RECURRENT DIFFUSE INTRINSIC) BRAIN STEM GLIOMA (3) CONSOLIDATED:
http://clinicaltrials.gov/show/NCT00003459
8/1998 – Study Start Date
� � � � � � � � � � � � � � � � �
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

10/1997 – Protocol BT-11 – BRAIN STEM GLIOMA
12 – Patients Accrued
12 – Evaluable Patients
1 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
8 / 50% – # and % of Patients Showing Stable Disease or Progressive Disease

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

5/1/2012 – Protocol BT-11
Antineoplaston Therapy in Treating Patients With BRAIN STEM GLIOMA
Brain and Central Nervous System Tumors
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11 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
http://clinicaltrials.gov/archive/NCT00003459/2007_10_17/changes
10/17/2007 – Updated
1 clinical_study status
2
Fm: No longer recruiting
To: Active, not recruiting
� � � � � � � � � � � � � � � � �

Scientific Publications
(former web-site screenshots)
http://www.circare.org/info/bri/burzynski_fdauntitled_promo_2012.pdf

http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

2003 – NEURO-ONCOLOGY

2003 – Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive multicentric glioma

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358

2004 – NEURO-ONCOLOGY

Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384

2004 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386

2004 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427

2004 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Treatment of primitive neuroectodermal tumors (PNET) with antineoplastons A10 and AS2-1 (ANP)

Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428

2004 – DRUGS IN R&D

Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M.

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma

A Preliminary Report
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf
Drugs R&D 2004;5(6):315-326

2004 – INTEGRATIVE CANCER THERAPIES

Review Articles on Clinical Trials:

Burzynski, S.R.

The Present State of Antineoplaston Research
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Integrative Cancer Therapies 2004;3:47-58

2004 – INTEGRATIVE CANCER THERAPIES

Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B.

Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261

2004 – DRUGS IN R&D
Drugs in R and D (Drugs in Research and Development)

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/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – median age

6 – pilocytic astrocytoma

4 – low-grade astrocytoma
1 – astrocytoma grade 2

1 – visual pathway glioma: biopsy not performed due to dangerous location

16 months – average duration intravenous ANP therapy

19 months – average duration oral ANP

1 – non-evaluable due to only 4 weeks of ANP: lack of follow-up scans

1 – stable disease discontinued ANP against medical advice: died 4.5 years later

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

1 – serious toxicity of reversible tinnitus, 1 day’s duration

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

CHILDREN WITH INCURABLE RECURRENT AND PROGRESSIVE MULTICENTRIC GLIOMA
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
12 – TOTAL

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

5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-13
BT-23

5/1/2012 – set forth below

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
CHILDREN WITH INCURABLE RECURRENT AND PROGRESSIVE MULTICENTRIC GLIOMA (3) CONSOLIDATED:
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
12 – TOTAL
http://clinicaltrials.gov/show/NCT00003468
5/1996 – Study Start Date

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
Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
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
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
http://clinicaltrials.gov/show/NCT00003468
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
6/9/2009 – Updated
1 clinical_study date
2
Fm: 2008-12
To: 2009-06
3 date last_release_date
4
Fm: 2008-12-23
To: 2009-06-09
5 last_release_date clinical_study
http://clinicaltrials.gov/show/NCT00003477
6/1996 – Study Start Date

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
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· 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
http://clinicaltrials.gov/show/NCT00003477
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/archive/NCT00003477/2009_06_09/changes
6/9/2009 – Updated
1 clinical_study date
2
Fm: 2008-12
To: 2009-06
3 date last_release_date
4
Fm: 2008-12-23
To: 2009-06-09
5 last_release_date clinical_study
� � � � � � � � � � � � � � � � �
2005 – INTEGRATIVE CANCER THERAPIES

Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with Antineoplastons A10 and AS2-1
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
Integrative Cancer Therapies 2005;4(2):168-177

2005 – INTEGRATIVE CANCER THERAPIES

6/2005 – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Phase II / Phase 2 studies

Primitive neuroectodermal tumors (PNETs)
usually successfully treated with craniospinal radiation and chemotherapy

difficulties with standard treatment can be encountered in:

1. very young children
2. adult patients at high risk of complication from standard treatment
3. patients with recurrent tumors

13 children – recurrent disease or high risk

treated with antineoplastons (ANP)

5 years, 7 months (range, 1-11) – median age

8 – Medulloblastoma
3 – pineoblastoma
2 – other PNET

Previous treatments:

12 – surgery (1 had biopsy only, suboccipital craniotomy)
6 – chemotherapy
6 – radiation therapy
6 – had not received prior chemotherapy or radiation

treatment – intravenous infusions of 2 formulations of ANP, A10 and AS2-1

20 months – administered for average

6 (46%) survived more than 5 years from initiation of ANP

5 – not treated earlier with radiation therapy or chemotherapy

serious side effects:
1 – fever
1 – granulocytopenia
1 – anemia

study ongoing and accruing additional patients

percentage of response is lower than standard treatment of favorable PNET

long-term survival in poor-risk cases and reduced toxicity makes ANP promising for:
1. very young children
2. patients at high risk of complication of standard therapy
3. patients with recurrent tumors

2005 – Protocol – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors
13 – Patients Accrued
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – # and % of Patients Showing Progressive Disease

LONG-TERM SURVIVAL OF HIGH-RISK PEDIATRIC PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMORS:
8 – Medulloblastoma
3 – pineoblastoma
2 – other
PNET (Primitive neuroectodermal tumors)
13 – TOTAL

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

5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-12

5/1/2012 – set forth below

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
LONG-TERM SURVIVAL OF HIGH-RISK PEDIATRIC PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMORS:
8 – Medulloblastoma
3 – pineoblastoma
2 – other PNET (Primitive neuroectodermal tumors)
13 – TOTAL
http://clinicaltrials.gov/show/NCT00003460
9/1995 – Study Start Date

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
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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
http://clinicaltrials.gov/show/NCT00003460
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)

7/14/2009 – Updated
1 clinical_study oversight_info
2 regulatory_authority
United States: Federal Government
3 oversight_info status
4
Fm: Recruiting
To: Active, not recruiting
5 status last_release_date
6
Fm: 2009-06-09
To: 2009-07-14
7 last_release_date
8 init_disposition_release_date
9 init_results_release_date clinical_study

Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
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

5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-12

5/1/2012 – set forth below

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 Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
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
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

Iwaaaa.pdf
Neuro-Oncology. 2006; 8:466

2006 – INTEGRATIVE CANCER THERAPIES

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B.

Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive brainstem glioma
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf
Integrative Cancer Therapies 2006;5(1):40-47

2006 – PEDIATRIC DRUGS

Burzynski, S.R.

Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
Pediatric Drugs 2006;8:167-178

2006 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R.A., Szymkowski, B., Janicki, T.J., Khan, M.I., Dolgopolov, V.

Complete response of a diffuse intrinsic brainstem tumor and von Hippel Lindau (VHL) disease to antineoplastons A10 and AS2-1 (ANP):

a case report
http://www.burzynskiclinic.com/images/stories/Publications/2104.pdf
Neuro-Oncology. 2006; 8:439

3/2006 – INTEGRATIVE CANCER THERAPIES

3/2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Brainstem glioma carries 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 even more challenging when inoperable tumor 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 – patient with anaplastic astrocytoma

5+ years – patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem in 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 assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well:
1 case – 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

INOPERABLE TUMOR OF HIGH-GRADE PATHOLOGY (HBSG), RECURRENT, AND PROGRESSIVE BRAINSTEM GLIOMA:
4 – glioblastomas (patient with glioblastoma)
14 – anaplastic HBSG (patient with anaplastic astrocytoma)
18 – TOTAL ; evaluable)
14 – diffuse intrinsic tumors
12 – recurrence
(recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem)
6 – did not have radiation therapy or chemotherapy
18 – TOTAL

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 PHASE 2 TRIALS:

INOPERABLE TUMOR OF HIGH-GRADE PATHOLOGY (HBSG), RECURRENT, AND PROGRESSIVE BRAINSTEM GLIOMA:
4 – glioblastomas (patient with glioblastoma)
14 – anaplastic HBSG (patient with anaplastic astrocytoma)
18 – TOTAL ; evaluable)
14 – diffuse intrinsic tumors
12 – recurrence
(recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem)
6 – did not have radiation therapy or chemotherapy
18 – TOTAL

Burzynski Clinical Trials

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61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

“The Company is currently conducting ONE FDA-approved CLINICAL TRIAL”

Form 10-Q (For the quarterly period ended November 30, 2012) (1/14/2013)

http://www.faqs.org/sec-filings/130114/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-Q