United States Food and Drug Administration (FDA): September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

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[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
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BB – Bob Blaskiewicz
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DJT – Didymus Judas Thomas
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0:47:00
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BB“Ummm, o-kay”

“Uh, I want to turn this over to the people who are watching”

“Um, I want to give them a a chance to address you as well”

“Uhmmm, hi everyone”
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0:48:00
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0:53:00
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BB“A every time that I and and and and, and David (James @StortSkeptic the Skeptic Canary) points this out, that um, you you know you’re not going to speculate about the the FDA but then at every turn you’re invoking the FDA as being obstructionist
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0:54:02
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BB“I, I just find that to be contradictory and and self-defeating
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DJT – Bob, exactly where did I invoke “the FDA as being obstructionist” ?
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1:02:00
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BB“Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work
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1:03:00
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BB“it’s it’s it’s up to Burzynski

“It’s up to Burzynski to show that his drug does work”

“And it’s always been his burden of proof

“He’s the one that’s been claiming this miracle cancer cure, forever”
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DJT – Bob, Burzynski showed and proved what he needed to prove to the FDA in order to do phase 2 clinical trials, 9/3/2004 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment of patients with brain stem glioma, .10/30/2008 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 and AS2-1 Antineoplaston) for treatment of gliomas, and FDA approved phase 3 [1-2]

Oh, and Bob, exactly when did Burzynski 1st claim “this miracle cancer cure” ?
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1:04:02
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BB“Um, that we’d love to see, however we can’t see, however we can’t see it because of proti protri proprietary uh protections that the FDA is giving to Burzynski, right ?”

They’re not sharing his trial designs because they are his trial designs, right ?”

“That the makeup of his drug that he’s distributing are his, uh design, and his intellectual property

“So the FDA is protecting him, uh from outside scrutiny
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DJT – Bob, you make it sound like it’s part of some grand “conspiracy” between Burzynski and the FDA to keep information from “The Skeptics™” [3]
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21CFR601

Subpart F–Confidentiality of Information

Sec. 601.50

Confidentiality of data and information in an investigational new drug notice for a biological product

(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged
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BB“While you may imagine that that, that that the FDA is is somehow antagonistic toward him

“They’ve given him every opportunity, over 60 opportunities to prove himself worth uh their confidence and hasn’t
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DJT – Bob, that certainly explains the 9/3/2004 and .10/30/2008 ODD’s and phase 3 clinical trial approvals by the FDA – NOT [1-2]
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1:05:00
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1:42:00
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BB“I don’t, the thing is though that, that that’s a inver, shifting the burden of proof off of Burzynski”

“Burzynski has to prove them wrong, has to prove him right”

“The FDA is not there to say this doesn’t work”
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DJT – Bob, who initiated and put into place the clinical trial hold ?

Burzynski ?

FDA ?

Both ?
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1:43:30
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BB“So, I mean, honestly, um, saying “Well, when the F, FDA tells you that it doesn’t work, the FDA’s never gonna say that because that’s not their job
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1:44:00
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BB“That’s not an option, because they’re never gonna do it

“They relinquish, a lot of authority, over to Burzynski, and his Institutional Review Board, which, I would mention, has failed 3 reviews in a row”
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Bob, where are the “final reports” for those “3 reviews” ?
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BB“Right ?”

“It is Burzynski’s job to be convincing”

“It is not our uh, uh, it it it he hasn’t produced in decades

“In decades”

“In hundreds and hundreds of patients, who’ve payed to be on this”

“Hell, we’d we’d we’d like a prelim, well when you’re talking about something that is so difficult as brainstem glioma, that type of thing gets, really does in the publishing stream get fast-tracked there”
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DJT – Bob, Burzynski has provided numerous phase 2 clinical trial preliminary reports, which our #fave oncologist has chosen to ignore [4]
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BB“they test it”

“Yeah, and they they they want uh, that was evidence of fast-tracking is what, that rejection was uh e was very quickly
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DJT – Bob, have you checked The Lancet Oncology [5] to see what was so much more important than Burzynski’s “phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results” [6] and the Japanese antineoplaston study ? [7]
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BB“So, how long will it be before Burzynski doesn’t publish, that you decide that uh perhaps he’s he‘s, doesn’t have the goods ?

“Um, so, uh, uh again, the FDA is not the arbiter of this

“It’s ultimately Burzynski”

“You’ve been speculating about what the FDA’s motivation are like crazy”

“Why not speculate about Burzynski a little bit”
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DJT – Well, how have I been speculating ?
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1:46:00
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BB“Well actually I’m not even asking you to speculate about Burzynski, I’m only asking you to tell me, how long would it take, uh how, for him to go unpublished like this, um, for this long, before you would doubt it ?”
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DJT – Note how, above, without proving it, Bob claimed “at every turn you’re invoking the FDA as being obstructionist”, and now, directly above, again, without proving it, Bob claims “You’ve been speculating about what the FDA’s motivation are like crazy”
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DJT – what the journals keep saying, in response
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BB“What ?”
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DJT – 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” ?
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BB“But these but but but that doesn’t have any bearing on

“That doesn’t”

“Oh I’m not asking you how long, how long, would it take you for you to start doubting whether or not he has the goods ?

“How long would it take ?”

“It’s a it’s a it’s a question that should be answered by a number uh uh months ?

“Years ?”

“How long ?”

“It’s been 15 years already”
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DJT – 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
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1:47:06
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DJT – Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
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BB – “I could push it back to 36 years”

“He hasn’t shown that it works for 36 years”

“I can do that”

“I was being nice”
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DJT – Note how Bob acts like he’s been hit with “The Stupid Stick”

If he wants to go back “36 years”, I can refer back to 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI), sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network, which advised, in part:

It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate” [8]
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DJT – The FDA A believes there is evidence of efficacy
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BB – “Perhaps based on bad phase 2”
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DJT – Well, we don’t know that

We don’t have the Freedom of Information Act information
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DJT – Remember, Bob is the one who told me during the 9/28/2013 Google+ Burzynski Discussion Hangout:

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

“Before you dismiss it you have to look into it”

“Everytime somebody throws uh uh something to me,
I have to look into it”

“That’s just, it’s my responsibility as a reader”

“T t and what I would honestly expect and hope, is that you would be honest about this, to yourself, and and and that’s the thing we don’t, we often don’t realize that we’re not being honest with ourself

“I try to fight against it, constantly”

Bob just ASSUMED that the FDA approved phase 3 clinical trials for Burzynski “Perhaps based on bad phase 2”, but tells me NOT to ASSUME ?
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BB“He withdrew”

“He withdrew the the phase 3 clinical trial”

“I that before recruiting,
although I’ve seen lots of people say they were on a phase 3 clinical trial

“I wonder how that happened”
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DJT – 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
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1:48:01
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BB“Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?
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DJT – 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
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Note how Bob pulls out the old “if they thought that he was a real doctor” line ?

Is Bob now claiming that Burzynski is NOT even a “real doctor” ?
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BB – “He’s changed things”
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DJT – Eric said they gave
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BB“That The Lancet is a top-tier journal like New England Journal of Medicine

“It’s basically be, besieged by uh 100′s of people submitting their, their, their reports”

“Um, it’s just, you know, let’s say he, someone has such a thin publishing record as Burzynski does, do you think that it’s likely that he will ever get in a top-tier journal ?

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

“There’s lots of places that he can go”
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DJT – We’ll I’m
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BB“Um, and he doesn’t seem to to have evailed himself of that, as far as I can tell

“And I would know because he’d get rejected, or he’d be crowing, you know”
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1:49:02
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BB – “Either way, he’s gonna tell us what happens”

He told us what happened with The Lancet, you know”

“I don’t have any evidence that suggests to me that he’s even trying”
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Note how Bob refers to Burzynski’s numerous publications as “such a thin publishing record”

Bob, do I need to count all of these for you ? [9]
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DJT – 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 study [7]
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BB – “So let’s go back to this”

“How long will it take ?”

“How long will it take before you, the Japanese study’s interesting too because we should be able to find that in the Japanese science databases, and we can find, we can’t find it at all

“We can’t find it anywhere”

“And, and those are in English, so it’s not a language problem

“We can’t find that anywhere”

“We’ve asked”

“We asked Rick Schiff, for, for that study”

“And, and it hasn’t come to us

“He is now I believe on the Board of Directors, over there”
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1:50:00
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BB – “He should have access to this”

“We can’t get it”
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Bob, did you ask:

1. Annals of Oncology 2010;21:viii221 ?

2. European Society for Medical Oncology (ESMO), Colorectal cancer, Abstract: 3558, May 17, 2010 ?

3. Colorectal Cancer Association of Canada, COLORECTAL CANCER RESEARCH, Month Ending June 19, 2009
11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets (May 27/09) pg. 5 of 20 ?

4. Kurume University School of Medicine (Japan) Department of Surgery ?

5. Hideaki Tsuda ? [7]
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BB – “How how long will it take before you recognize that, nothing is forthcoming ?”

“How long would that take ?”
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DJT – 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
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BB“Well, I mean, were talking about a blog here

“We’re talking about life”

“No, we’re talking about a blogger’s feelings in that case

“In in this case we’re talking about, 1,000′s of patients, over the course of of of generations, you know”

“This is important stuff”

“This is not eh eh equating what’s happening to to patients with what’s happening to you is is completely off-kilter as far as I can tell

“It’s nothing”

“It’s nothing like you not getting to say something on my web-site”

“You know”

“This is they they have thrown in with Burzynski, and they’ve trusted him, and he’s produced nothing

“Nothing of substance”
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1:51:00
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BB – “Nothing that that has made all of that um, uh, n nothing th th th that uh his peers would take seriously”

“The other thing that that that strikes me now is that, you know, you you you you keep saying that, well Eric is going to to share things with you”

“Does it ever concern you eh uh eh occur to you that Eric might not be reliable ?”
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Bob, do you want to have a contest to determine which of you is more “reliable” ?
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DJT – Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it [6]
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BB“He then, and then he”

“And then he he, you know, the the the the dialogue that sprung up around that was, well see, he’s never going to get to get published”

“Well you’re just setting yourself up for wish fulfillment”

“You want him to be, persecuted, so you are ecstatic when he doesn’t get to publish, which is unfortunate for all the cancer patients, who really thought that one day, all the studies were going to be published”
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1:52:00
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DJT – 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
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BB – “Where has Eric been wrong ?”
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DJT – 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
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BB“It’s it’s it’s it’s a form letter

“You know”

“They’re just saying, “No thanks””

““Thanks, but no thanks” is what they were saying, in the most generic way possible”

“Like I said, they’re besieged by researchers trying to publish
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1:53:05
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DJT – 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
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BB“So, so, possibly”

“So possibly what you are saying is that they in fact have read it, and after having read it they’ve rejected it”

“Is that what you’re saying ?”

“Because that’s what peer-review is”
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DJT – 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
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BB – “Do you know it was the same editor, that it came from the same desk ?”

“You can’t make that assumption that that the form letter will be the same form letter every time”

“I mean you just can’t

“I mean in in some ways we have a lot of non-information that you’re filling in, with what you expect, as as opposed to what’s actually really there, and I I I just think you’re putting too much uh stock in one uh, uh, in in in in this uh the publication kerfuffle
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1:54:16
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BB“Um”
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DJT – 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
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BB“Well, not necessarily

“I’ve been in any # of professional groups where the organization is just not optimal, and publications certainly th there are all sorts of pressures from all sorts of different places”
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1:55:08
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BB“I I have no problems whatsoever with seeing that this might not be completely uh um uh streamlining uniform processes as possible

“The fact that it’s not uniform, doesn’t have anything to do with Burzynski not publishing, not producing good data”

“Not just going to a, you know, god, even if, even if, let’s put it this way, even if he went to a pay to play type publication where you have to pay in order to get your manuscript accepted; and he has the money to do this, it wouldn’t take that much, and he were to put out a good protocol, and he were to show us his data, and he would make his, his his stuff accessible to us, then we could validate it, then we could look at it and say, “Yeah, this is good,” or “No, this is the problem, you have to go back and you have to fix this””

“Right ?”

“So we really, every time we talk about the letter that he got, yeah that doesn’t have much to do with anything, really”
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1:56:02
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BB – “We wanna see the frickin’ data”

“And if he had a cure for some cancers that otherwise don’t have reliable treatments, he has an obligation to get that out there anyway he can

“And if if peer-review doesn’t, you know, play a, if peer-review can’t do it, you know, isn’t fast enough for him, then he should take it to the web, and he should send copies out to every pediatric, uh, you know, oncologist that there is

“That’s the way to do it”
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DJT – Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynskishould publish
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1:57:10
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BB“It’s the, it’s the data itself

“If if Burzynski is is, is confident in his data, he will put it out there

“Right ?”

“One way or the other”
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DJT – 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”

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1:58:04
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DJT – So then he can go on, you know, for however many years he wants to
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2:01:00
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BB“Um, almost no treatment goes out without trials

“Massive amounts of data are required”
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Bob, do you think that’s the 2.5 million pages of clinical trial data that Fabio said Burzynski sent to the FDA ? [10]
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2:02:00
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BB“Uh, in in in that sense, you know, uh all the the the, you know, kind of back-peddling and and and trying to defend him is is going to, not going to help his case at all
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Bob, exactly where did I exhibit any “kind of back-peddling” ?
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2:03:03
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BB
“You are, honestly as far as I can tell you are doing the um, you know, you’re you’re ah throwing up uh, uh, uh, you’re giving me another uh invisible dragon in the garage, um”
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DJT – 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
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2:04:11
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BB“Okay, so”

“What you’re telling me is that you trust the FDA to to be able to tell you when he’s not doing, good science, but also that you don’t trust the FDA”

“Do you see an inherent conflict there ?”
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DJT – How did I say I, I didn’t trust them ?
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BB“Well, when I, whenever I would ask about, like, why would these trials aren’t happening uh and, you know, you say well the the FDA’s arranged it

“The FDA’s in control”

“They sign off on these things”

“But they’re they’re they’re they’re at the same that they’re, they’re trustworthy they’re also not trustworthy depending on what you need for the particular argument at the time
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2:05:12
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BB – “You’re suggesting that they’re untrustworthy”
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DJT – No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em [11]
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BB“Do you know that the FDA pulled out of the prosecution ?”

“Did you know that the FDA pulled out of the prosecution um of his criminal case, because they were backing a researcher ?”
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Bob, would that “researcher” be Dvorit D. Samid, who was in Burzynski: Cancer is Serious Business (Part I) ?
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DJT – Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution

I mean
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BB“Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
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DJT – Right
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BB“Right”

“And and, they declined to provide information that the prosecution needed

“That’s important”

“That that that’s really important

“That he has been given the benefit of the doubt, and he has come up wanting, for decades now”
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DJT – 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 you 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
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2:10:15
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BB“One of the interesting things about Doubting Thomas that I think you should definitely consider for yourself, is that at some point, when faced with the real opportunity to prove or disprove his assertions, he doubted himself”

“And that’s important”

“And that’s where you’re falling short in the analogy”
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DJT – Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
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BB – “I’ve laid out exactly what it would take for me to turn on a fucking dime”

“I have, I have made it abundantly clear what I need

“Gorski has made it abundantly clear”

“Everybody else, Guy, and David, and Josephine Jones, uh, the Morgans, all of them have made it abundantly clear, what it would take to change our minds, and you’ve never done that”
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2:11:02
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BB“And even in this, this was an opportunity to do that

“To come up with a basis for understanding, where it’s like, you know what, If we can show this, you know, if we can show a this guy, that, that, there, that his standards are not being met, then, you know, we could possibly have some sort of ongoing dialogue after this”
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DJT – So I can say that since the Mayo Clinic (Correction: M.D. Anderson) 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
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BB“Why wasn’t that study”
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DJT – for me to make up my mind (laughing)
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BB“Why wasn’t that, that that that, still . . again, it it doesn’t seem really to to approach the the the, main question here

“You know, um . . what are the standards that you have that it isn’t, what are your standards to show that it isn’t efficacious ?
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2:12:05
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DJT – Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo (Correction: M.D. Anderson) to publish their study; which was from 2006 to 2013
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BB“Why was the Mayo”

“Why was the Mayo (Correction: M.D. Anderson) study delayed ?”
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Note how Bob ASSUMES that the publishing of the final results of the M.D. Anderson study were delayed
——————————————————————
DJT – How do you know it was delayed ?
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BB“Well you said you had so many years before you finish it and go in”
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DJT – I mean, has anybody
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BB“Why, why did it take so long ?
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DJT – 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
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BB“I have something for you, okay ?”

“Send me that”

“Could you send me that study the way that it was published because um, just just send me the final study, um, to my e-mail address”
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DJT – Sure
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BB“Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between”
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2:13:03
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BB – “Why did it take so long for it, for it to come out”
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DJT – 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
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BB“Right”

“Um, but it it would, perhaps, answer the question; because you’re using it as an example on the basis of which to dismiss criticism, whether or not, uh, it is the standard, and therefor you’re allowed to accept that Burzynski hasn’t published until 2016, or, um, it’s an anomaly, which is also a possibility, that most stuff comes out more quickly
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DJT – 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”
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2:14:07
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BB“I I, yeah, the other thing that David James points out is you know, why 2016 when he’s had 36 years already ?
======================================
DJT – Again, we get back to, when the clinical trial is finished, not when Burzynski started
======================================
BB“Treating people”
======================================
DJT – I mean, you would expect to find a results to be published after, the final results are in
======================================
BB – “You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
======================================
DJT – You would expect some people would want to have confidentiality, and maybe not want to be included
======================================
BB – “So, if you’re unsure about this stuff, if you’re unsure about the the time to publication, why are you defending it so hard, other than saying, “I don’t know, I really need to”
======================================
DJT – Why am I unsure ?
======================================
BB“Uh about the
======================================
DJT – (laughing) I just gave you an example
======================================
BB“The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
——————————————————————
2:15:02
======================================
DJT – Oh, who said I was unsure ?

I just gave you an example
——————————————————————
Note how Bob ASSUMES that I’m “unsure” when I had the same answer since 0:32:07 [12]

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

Bob, It’s your unlucky [13]
======================================
REFERENCES:
======================================
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[2] – FDA grants Orphan Drug Designation (ODD) for A10 and AS2-1:
——————————————————————
http://www.burzynskiresearch.com/assets/PressRelease_12022008_BZYR(2).pdf
——————————————————————
josephinejones (@_JosephineJones), D Nile ist http://josephinejones.wordpress.com/2013/01/23/happy-birthday-dr-burzynski-and-goodbye-antineoplastons/comment-page-1/#comment-8921
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/23/josephinejones-_josephinejones-d-nile-ist-httpjosephinejones-wordpress-com20130123happy-birthday-dr-burzynski-and-goodbye-antineoplastonscomment-page-1comment-8921/
======================================
[3] – The Skeptics @Majikthyse reveals madjik research skilz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/26/the-skeptics-majikthyse-reveals-madjik-research-skilz/
======================================
[4] – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
[5] – The Lancet Oncology
——————————————————————
http://www.thelancet.com/journals/lanonc/onlinefirst
——————————————————————
http://www.thelancet.com/journals/lanonc/issue/current
======================================
[6] – FINALLY, one of “The Skeptics™” has the “Balls” to do what even Dr. David H. “Orac” Gorski would NOT do:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/12/finally-one-of-the-skeptics-has-the-balls-to-do-what-even-dr-david-h-orac-gorski-would-not-do/
======================================
[7] – Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study/
======================================
[8] – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[9] – Stanislaw Rajmund Burzynski Publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/16/stanislaw-rajmund-burzynski-publications/
======================================
[10] – Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
[11] – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
[12] – The Biggest Loser: “The Skeptics™” Guy Chapman (guychapman @vGuyUK @SceptiGuy) http://www.chapmancentral.co.uk/blahg/ – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/the-biggest-loser-the-skeptics-guy-chapman-guychapman-vguyuk-sceptiguy-httpwww-chapmancentral-co-ukblahg-september-28-2013-the-skeptics/
======================================
[13] – Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
======================================

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QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER

1. One “Orac” (Dr. David H. Gorski @oracknows @sciencebasedmed @gorskon #sciencebasedmedicine
http://www.scienceblogs.com/Insolence
http://www.sciencebasedmedicine.org)
claimed:


“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”

When I requested that he respond to Burzynski’s comments re the study, he would NOT touch it with the proverbial ZZ Top

“Ten-Foot Pole”

What Critic, Cynic, or one of “The Skeptics™” is going to show more Bravery and Courage than “Orac”?
� � � � � � � � � � � � � � � � �
2. If antineoplastons do NOT work, why, after Dvorit D. SAMID learned of them from Burzynski, did all the research, clinical studies, and phase I, phase II, and phase III clinical trials really start to get underway on
PHENYLACETYLGLUTAMINATE (PAG or PG)
PHENYLACETATE (PN)

and
PHENYLBUTYRATE (PB)?
� � � � � � � � � � � � � � � � �
3. This individual claims to be a “cancer researcher”

If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?

My review of C0nc0rdance:
https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance/
� � � � � � � � � � � � � � � � �
4. This individual claims to be a “Doctor,” “oncologist,” “breast cancer specialist,” and “cancer researcher”

If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?

Paging Doctor David H. Gorski, Paging Doctor David H. Gorski: There’s Mud in your Ears … Doktor Gorski?:
https://stanislawrajmundburzynski.wordpress.com/2013/05/28/paging-doctor-david-h-gorski-paging-doctor-david-h-gorski-theres-mud-in-your-ears-doktor-gorski/
He did NOT even refer to the below publication by Burzynski regarding “Treatment of Recurrent Triple-Negative Breast Cancer:”

8/2011 – Successful Treatment of Recurrent Triple-Negative Breast Cancer with Combination of Targeted Therapies
http://www.scirp.org/journal/PaperDownload.aspx?DOI=10.4236/jct.2011.23050
Journal of Cancer Therapy, 2011, 2, 372-376
doi:10.4236/jct.2011.23050 Published Online August 2011
(http://www.SciRP.org/journal/jct)
� � � � � � � � � � � � � � � � �
5. Critics, Cynics, “The Skeptics™” state that Burzynski is NOT an oncologist, but can offer no explanation as to why this is supposedly “relevant,” they cannot explain if oncologists are somehow “better” than biochemists, nor do they want to answer the question:

“Does Burzynski work with any oncologists, and are any of them listed on his phase II clinical trial publications”?

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. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008
http://t.co/nFpwlQg275
15.5% (120) survived more than 5 years

Critics, Cynics, “The Skeptics™”, what’s your survival rate?
� � � � � � � � � � � � � � � � �
7. March 29, 1996

Then United States Food and Drug Administration Commissioner, David A. Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trialsfewer patients … if there is evidence … of partial response in clinical trials

I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials

3. We will accept … less information … up front –

4. we’re going to require further study AFTERapproval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point

You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded accessavailabilityfor American patients for any drugthere’s reason to believemay work
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of partial response“?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?

https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
� � � � � � � � � � � � � � � � �
8. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008
http://t.co/nFpwlQg275
Is that what the FDA means by:

rely on … fewer patients?
� � � � � � � � � � � � � � � � �
9. 4/27/2013 (37:20) Fabio stated that
Burzynski had provided the FDA with 2.5 million pages of clinical trial documents
http://youtu.be/BuNr06BuXkk
Is that what the FDA means by:

“unnecessary paperwork”?

and

“less information … up front”?
� � � � � � � � � � � � � � � � �
10. Is this what the FDA means by:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
if there is evidence … of partial response in clinical trials?
� � � � � � � � � � � � � � � � �
11. Why was the United States Food and Drug Administration requiring that radiation be used in the Phase 3 Clinical Trial when Burzynski has shown better results with antineoplastons when radiation is NOT used?
� � � � � � � � � � � � � � � � �
12. Who wants to defend the excuse that The Lancet gave for NOT Publishing the documentation which Burzynski sent to them, which is referred to in Burzynski: Cancer is Serious Business, Part II?
� � � � � � � � � � � � � � � � �
13. Review Articles on Clinical Trials: 2. 2006 – Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178.
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 174

2.3. Targeted Therapy

1652 adults
335 children
[147]


indicates 1,799 Burzynski patients

Is that what the FDA means by:

rely on … fewer patients?
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13. The FDA approved phase III (3) clinical trials for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal); which means that they have shown evidence of effectiveness, yet they have NOT granted Accelerated Approval for them, even though they have done so for other treatments which had NOT yet published the final results of phase II (2) clinical trials, and which did NOT have as good Complete Response, Partial Response, Stable Disease, Minor Response, Progressive Disease, Objective Response, Progression-Free Survival, etc., rates:

Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/

(Additional QUESTIONS being added)

� � � � � � � � � � � � � � � � �
References:

1.

Post #73 – Didymus Judas Thomas

At the Tu-Quack Center Oracles of Deny to Respond tree

1/30/2013

Post #52 – Orac

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so.”

Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?

1. “[T]he study tested a dosing regimen known to be ineffective.”

2. “[D]osages used in the study “were meant for the treatment of a single small lesion…”

3. “5 of the 6 evaluable patients had either multiple nodules or tumors larger than” said single small lesion.

4. “As the provider,” SRB “strongly suggested to the NCI that these patients receive a much higher dose, consistent with their greater tumor load.”

5. “[T]he study was closed when” SRB “insisted that the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used (letter to Dr M. Sznol, NCI, on 4/20/1995).”

6. “A review of the clinical data in the article … proves the validity of” SRB’s “position” per SRB

7. “Their study patients had extremely low plasma antineoplaston levels.”

8. SRB’s “phase 2 study dosage regimen produced plasma phenylacetylglutamine levels that are 35 times greater, phenylacetylisoglutamine levels 53 times greater, and phenylacetate levels 2 times greater than those reported…’”

9. “The clinical outcomes reported … based on their inadequate dosage schedule, differ dramatically from” SRB’s “phase 2 studies in which a higher dosage regimen was used.”

10. “They reported no tumor regression. In contrast, in 1 of” SRB’s “ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses.’”

11. “The difference in outcomes is primarily due to the difference in dosage schedules,” per SRB

12. “Another factor that may have caused a lack of response in the study by … is that the duration of treatment was too brief.”

13. “Almost all the patients in their study received treatment for less than 30 days.”

14. “1 patient received only 9 days of treatment.”

15. “The current studies indicate that objective tumor responses are usually observed after 3 months of therapy.”

16. “An additional 8 months of treatment is usually needed to obtain a maximal therapeutic effect.”

17. “[A]mbiguities in the response evaluation and analysis in the article…”

a) “In 2 patients, tumor necrosis was attributed to “radionecrosis.””

b) “However, such an interpretation is clouded by the fact that antineoplaston-induced necrosis can be indistinguishable from radionecrosis.”

c) “Moreover, the analysis … could have highlighted the 2 patients with recurrent glioblastoma who survived for more than I year.”

d) “This is of interest because these patients typically have a life expectancy of 3 to 6 months.”

18. “It is regrettable that, at the time of the study … the sponsor, NCI, decided against the higher dosing regimen that I proposed and closed the study.”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech/
IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/important-the-live-debate-that-wasnt-a-film-producer-a-cancer-doctor-and-their-critics/
Post #85 – Orac – April 28, 2013

“Well, DJT tried to comment last night and got caught in the moderation trap.”

“I’m not letting DJT through.”

“He’s been banned for very good reason, and I will not rescind the ban.”
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
My below blog contained a copy of the comment I submitted to his blog:
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
All Mr. Hinton would have to do is ask “Orac” to respond to my post 73 on his blog, and it would be all over, since “Orac” has adopted his “Hold the Mayo” attitude, and shows no indication that he would ever be brave enough to touch it with the proverbial ZZ Top

“Ten Foot Pole”

because he’s probably aware of what would happen if he did

One of “Orac’s” “Oracolytes” posted on Forbes (#Forbes):
onforb.es/11pwse9

http://t.co/vh3cgAR6hW
“I already offered you a forum on a science blog to debate with a real respected surgical oncologist, with a guarantee that he never moderates the “debate”.”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
This is Dr. David H. Gorski’s blog

Dr. Gorski censored (blocked) my comments

We are supposed to believe that he’s now NOT going to block someone’s comments???
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
#66 – Didymus Judas Thomas

IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics | Didymus Judas Thomas’ Hipocritical Oath Blog

April 27, 2013

Your comment is awaiting moderation.

Seriously ? Gorski ? Let’s remember that it is YOU who would NOT answer my questions, and instead inacted your “Hold the Mayo” posture re post 73

Let’s review your

“deconstructed his “evidence” in depth before” claim

1/21/2013 Orac posted THIS blog:

“Quoth Joe Mercola:

I love me some Burzynski antineoplastons

Posted by Orac on January 21, 2013″

” … In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy”

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
I challenged “Orac” about this and this reply was posted which included my point at the beginning of the reply:

1/29/2013

“An excellent explanation of how dubious Stanislaw Burzynski’s activities are”

Posted by Orac on January 28, 2013
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-of-how-dubious-stanislaw-burzynskis-activities-are
Post #52 – Orac

January 29, 2013

“CONCLUSION: Although we could not confirm any tumor regression in patients in this study, THE SMALL SAMPLE SIZE PRECLUDES DEFINITIVE CONCLUSIONS ABOUT TREATMENT EFFICACY.”

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so”

I responded to Orac, quoting his reply at the beginning of my reply:

Post #73 – Didymus Judas Thomas

At the Tu-Quack Center Oracles of Deny to Respond tree

January 30, 2013

Post #52 – Orac

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so”

Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?

[SOURCE: Feb. 1999 Mayo Clinic Publication pg 2, 3 PDF]
http://burzynskimovie.com/images/stories/transcript/Documents/Feb99MayoClinicPubANP.pdf
2/1999 – A10 and AS2-1 – Phase II – Mayo Clinic Proceedings http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma Objective:
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
To assess the pharmacokinetics, toxicity, and efficacy of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Design:
http://www.sciencedirect.com/science/article/pii/S0025619611638354
We initiated a phase II trial in order to determine whether evidence of antitumor activity of A10 and AS2-1 could be documented
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf
Comment in Jun; 74 (6): 641-2
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 74(2):9 (1999)
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
1999 Elsevier Ltd.
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
DOI: 10.4065/74.2.137
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
Mayo Clin Proc 1999; 74: 137–45

Burzynski responded by pointing out:

6/1999 – A10 and AS2-1 – SRB http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2 Comment on Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942 Elsevier Science
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clinic Proc. 1999; 74: 641–642 (letter) 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc 74 (6): 1 (1999), 1999 Elsevier Ltd.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
DOI: 10.4065/74.6.641

This was responded to:

6/1999 – Mayo Clin Proc 74(6):2 (1999), DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
Volume 74, Issue 6 , Pages 641-642, June 1999
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS002561961164144X.pdf
References:

1. SAMID D , Shack S, Sherman LT. Phenylacetate: a novel nontoxic inducer of tumor cell differentiation. Cancer Res . 1992; 52:1988–1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
2. Danesi R, Nardini D, Basolo F, Del Tacca M, SAMID D . Myers CEo Phenylacetate inhibits protein isoprenylation and growth of the androgen-independent LNCaP prostate cancer cells transfected with the T24 Ha-ras oncogene. Mol Pharmacal. 1996; 49:972–979
http://www.ncbi.nlm.nih.gov/m/pubmed/8649357/

http://m.molpharm.aspetjournals.org/content/49/6/972.long
3. Chang SM, Kuhn LG, Robins HI, et al. Phase II study of phenylacetate in patients with recurrent malignant glioma: a North American Brain Tumor Consortium report. J Clin Oneal. 1999; 17:984–990
http://www.ncbi.nlm.nih.gov/m/pubmed/10071293/

http://m.jco.ascopubs.org/content/17/3/984.long
4. Thibault A, Cooper MR, Figg WD, et al. (SAMID D). A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Res. 1994; 54:1690–1694
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/

http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract

http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf

http://cancerres.aacrjournals.org/content/54/7/1690
PII: S0025-6196(11)64144-X

doi: 10.1016/S0025-6196(11)64144-X

1999 Mayo Foundation for Medical Education and Research.
Elsevier Inc.

The above four (4) references in the response to Burzynski might be relevant if all that antineoplastons consisted of was phenylacetate

Phenylacetylglutaminate (PAG or PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1

Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10

AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and Phenylacetylglutamine (PAG or PG)

National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
This is “what would happen” if “Orac” did have the “Bravery,” “Courage,” “Gumption,” “Intestinal Fortitude,” “Testicular Fortitude,” to address this issue:
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf
Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons:
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-managing-social-conflict-in-complementary-and-alternative-medicine-research-the-case-of-antineoplastons/
� � � � � � � � � � � � � � � � �
2.
Antineoplastons: Phenylacetylglutaminate (PG or PAG), Phenylacetate (PN), and Phenylbutyrate (PB):
https://stanislawrajmundburzynski.wordpress.com/2013/06/17/phenylacetylglutaminate-pg-or-pag-phenylacetate-pn-and-phenylbutyrate-pb/
Phenylacetylglutamine (PG or PAG):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylacetylglutamine-pg-or-pag/
Phenylacetate (PN):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylacetate-pn/
Phenylbutyrate (PB):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylbutyrate-pb/
� � � � � � � � � � � � � � � � �

Phenylbutyrate (PB)

Dvorit D. SAMID learned about PHENYLBUTYRATE (PB) from Burzynski
� � � � � � � � � � � � � � � � �
Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10
� � � � � � � � � � � � � � � � �
Phenylacetylglutaminate (PAG or PG) and Phenylacetate (PN) are metabolites of PHENYLBUTYRATE (PB) and are constituents of antineoplaston AS2-1
� � � � � � � � � � � � � � � � �
National Cancer Institute (NCI)
at the National Institutes of Health (NIH) Antineoplastons
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
� � � � � � � � � � � � � � � � �
Sodium PHENYLBUTYRATE (PB)
Year – Pubmed (110 entries)
1958 1st entry
1995 1st clinical trial
2001 Phase 1
2009 Phase 2
2012 Phase 3
� � � � � � � � � � � � � � � � �
PHENYLBUTYRATE (PB)
19 (PHENYLBUTYRATE (PB + SAMID)
http://www.ncbi.nlm.nih.gov/m/pubmed/?term=Phenylbutyrate+Samid
� � � � � � � � � � � � � � � � �
IV. Aetna considers SODIUM PHENYLBUTYRATE medically necessary for the treatment of acute promyelocytic leukemia and malignant glioma
http://www.aetna.com/cpb/medical/data/200_299/0240.html
� � � � � � � � � � � � � � � � �
The FDA has approved SODIUM PHENYLBUTYRATE as a treatment to remove ammonia from the bloodstream in individuals with urea cycle disorders
� � � � � � � � � � � � � � � � �
SODIUM PHENYLBUTYRATE was given an orphan drug designation by the FDA for use as an adjunct to surgery, radiation therapy, and chemotherapy for treatment of individuals with primary or recurrent malignant glioma
http://www.anthem.com/medicalpolicies/policies/mp_pw_a050524.htm
� � � � � � � � � � � � � � � � �
Cumulative List of all Products that have received Orphan Designation: Total active designations: 2002 Effecive: (sic – Effective) 5/5/2009
http://www.fda.gov/downloads/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/ucm162066.xls
PHENYLBUTYRATE (PB) and SODIUM PHENYLBUTYRATE are listed alphabetically in the lower 1/4th of this document
� � � � � � � � � � � � � � � � �
Pubmed 110 entries
Sodium PHENYLBUTYRATE
“Sodium PHENYLBUTYRATE (aka PB) …”
� � � � � � � � � � � � � � � � �
If they’re going to include it in a phase 3 study, than it’s “fair game”
http://www.ncbi.nlm.nih.gov/m/pubmed/22961727
Hepatology
Early View (Online Version of Record published before inclusion in an issue)

Article first published online: 3 JAN 2013

DOI: 10.1002/hep.26058
http://onlinelibrary.wiley.com/doi/10.1002/hep.26058/abstract;jsessionid=34AE3D61DEEF5356F147DE74B26759F9.d01t03
Article:
http://onlinelibrary.wiley.com/doi/10.1002/hep.26058/full
References:
http://onlinelibrary.wiley.com/doi/10.1002/hep.26058/references
Cited by:
http://onlinelibrary.wiley.com/doi/10.1002/hep.26058/citedby

Hepatology. 2012 Sep 7. doi: 10.1002/hep.26058. [Epub ahead of print]
� � � � � � � � � � � � � � � � �
1990 – Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/2152694/
BURZYNSKI, S. R., Kubove E., Burzynski, B.
Drugs Exp. Clin. Res., 16: 361-369, 1990.
� � � � � � � � � � � � � � � � �
1991 – Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
SAMID D., Shack S., Myers C.
J. Clin. Investig., 91: 2288-2295, 1991.
J Clin Invest. 1993 May; 91(5): 2288–2295.
doi: 10.1172/JCI116457
PMCID: PMC288233

References:

SAMID D, Flessate DM, Friedman RM. Interferon-induced revertants of ras-transformed cells:

resistance to transformation by specific oncogenes and retransformation by 5-azacytidine. Mol Cell Biol. 1987 Jun;7(6):2196–2200.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365343/

http://www.ncbi.nlm.nih.gov/m/pubmed/2439904/
SAMID D, Shack S, Sherman LT. Phenylacetate:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res. 1992 Apr 1;52(7):1988–1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://cancerres.aacrjournals.org/content/52/7/1988
SAMID D, Yeh A, Prasanna P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate. Blood. 1992 Sep 15;80(6):1576–1581.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
Dover GJ, Brusilow S, SAMID D. Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE. N Engl J Med. 1992 Aug 20;327(8):569–570.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
� � � � � � � � � � � � � � � � �
4/1/1992Phenylacetate:

A novel non-toxic inducer of tumor cell differentiation
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
SAMID D, Shack S , Sherman L T
http://cancerres.aacrjournals.org/content/52/7/1988
Cancer Res 52:1988,1992
Cancer Res. 1992 Apr 1;52(7):1988-92.
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland.
↵1 Supported by Elan Pharmaceutical Corporation Grant G174ED.
Reference: 12 (SAMID, D.)
� � � � � � � � � � � � � � � � �
8/20/1992 – Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
Dover GJ, Brusilow S, SAMID D
N Engl J Med 327569, 1992
N Engl J Med. 1992 Aug 20;327(8):569–570.
� � � � � � � � � � � � � � � � �
9/15/1992 – Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
SAMID D, Yeh A, Prasanna P
Blood 80:1576, 1992
Blood. 1992 Sep 15;80(6):1576–1581.
Blood. 1992 Sep 15;80(6):1576-81.
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD.

References:

15. SAMID D, Shack S, Ti-Sherman L Phenylacetate-A novel nontoxic inducer of tumor cell differentiation. Cancer Res 52:1988, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res. 1992 Apr 1;52(7):1988-92.
http://cancerres.aacrjournals.org/content/52/7/1988
20. SAMID D, Flessate DM, Friedman RM: Interferon-induced revertants of ras-transformed cells:

Resistance to transformation by specific oncogenes and retransformation by 5-azacytidine. Mol Cell Biol7:2196,1987
http://www.ncbi.nlm.nih.gov/m/pubmed/2439904/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365343/
21. Rimoldi D, Srikantan V, Wilson VL, Bassin RH,SAMID D: Increased sensitivity of nontumorigenic fibroblasts expressing ras or myconcogenes to malignant transformation induced by 5-aza-2‘- deoxycytidine. Cancer Res 51:324,1991
http://www.ncbi.nlm.nih.gov/m/pubmed/1703037/

http://m.cancerres.aacrjournals.org/content/51/1/324.abstract

http://m.cancerres.aacrjournals.org/content/51/1/324.full.pdf

http://cancerres.aacrjournals.org/content/51/1/324
34. Dover GJ, Brusilow S, SAMID D: Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE. N Engl J Med 327569,1992
N Engl J Med. 1992 Aug 20;327(8):569–570.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
� � � � � � � � � � � � � � � � �
5/1993 – Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic, pharmacological concentrations of phenylacetate.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
SAMID D, Shack S, Myers CE:
J Clin Invest 91:2288, 1993
J Clin Invest. 1993 May; 91(5): 2288–2295.
doi: 10.1172/JCI116457
PMCID: PMC288233

References:

9. SAMID D, Flessate DM, Friedman RM. Interferon-induced revertants of ras-transformed cells: resistance to transformation by specific oncogenes and retransformation by 5-azacytidine. Mol Cell Biol. 1987 Jun;7(6):2196–2200.
http://www.ncbi.nlm.nih.gov/m/pubmed/2439904/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365343/

http://mcb.asm.org/content/7/6/2196.full.pdf
13. SAMID D, Shack S, Sherman LT. Phenylacetate:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res. 1992 Apr 1;52(7):1988–1992.
Cancer Res 52:1988, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res. 1992 Apr 1;52(7):1988-92.
http://cancerres.aacrjournals.org/content/52/7/1988
14. SAMID D, Yeh A, Prasanna P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate. Blood. 1992 Sep 15;80(6):1576–1581.
Blood 80:1576, 1992
Blood. 1992 Sep 15;80(6):1576-81.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
17. Dover GJ, Brusilow S, SAMID D. Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE. N Engl J Med. 1992 Aug 20;327(8):569–570.
N Engl J Med 327569,1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
33. D. SAMID
� � � � � � � � � � � � � � � � �
10/1/1993 – Enhanced fetal
hemoglobin production by phenylacetate and 4-PHENYLBUTYRATE in erythroid precursors derived from normal blood donors and patients with sickle cell anemia and P-thalassemia
http://www.ncbi.nlm.nih.gov/m/pubmed/7691251/
Fibach E, Prasanna P, Rodgers GP, SAMID D:
Blood 822203, 1993
Blood. 1993 Oct 1;82(7):2203-9.
Department of Hematology, Hadassah University Hospital, Jerusalem, Israel.

References:

15. (SAMID D)

19. SAMID D, Yeh A, Prasanna P Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate. Blood 80:1576, 1992
Blood. 1992 Sep 15;80(6):1576–1581.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
20. Dover GJ, Brusilow S, SAMID D: Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE. N Engl J Med 327569, 1992
N Engl J Med. 1992 Aug 20;327(8):569–570.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
3I. SAMID D, Shack S, Ti-Sherman L Phenylacetate-A novel
nontoxic inducer of tumor cell differentiation. Cancer Res 52:1988, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res. 1992 Apr 1;52(7):1988-92.
http://cancerres.aacrjournals.org/content/52/7/1988
32. SAMID D, Shack S, Myers CE: Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic, pharmacological concentrations of phenylacetate. J Clin Invest 91:2288, 1993
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
� � � � � � � � � � � � � � � � �
4/1/1994 Phase 1
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer
http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract
Thibault A, Cooper MR, Figg WD, Venzon DJ, Sartor AO, Tompkins AC, Weinberger MS, Headlee DJ, McCall NA, SAMID D, et al.
http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf
Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
Cancer Res. 1994 Apr 1;54(7):1690-4.
Cancer Res 54(7):1690-4 (1994), PMID.8137283
recent version of this article at: http://cancerres.aacrjournals.org/content/54/7/1690
References:

8. SAMID, A., Shack, S., and Sherman, L. T. Phenylacetate:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res., 52: 1988-1992, 1992.
Cancer Res 52:1988, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res. 1992 Apr 1;52(7):1988-92.
http://cancerres.aacrjournals.org/content/52/7/1988
9. SAMID, D., Yen, A., and Prasana, P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate. Blood, 80: 1576-1581, 1992.
Blood 80:1576, 1992
Blood. 1992 Sep 15;80(6):1576–1581.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
10. SAMID, D., Shack, S., and Myers, C. E. Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate. J. Clin. Invest., 91: 2288-2295, 1993.
J Clin Invest 91:2288, 1993
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
11. SAMID. D., Ram, Z., Hudgins, W. R., Shack, S., Liu, L., Walbridge, S., Oldfield, E. H., Myers, C. E. Selective activity of phenylacetate against malignant gliomas:

resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1994.
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/
12. Dover, G. J., Brusilow, S., and SAMID, D. Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE. N. Engl. J. Med., 327: 569-570, 1992.
N Engl J Med 327569, 1992
N Engl J Med. 1992 Aug 20;327(8):569–570.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
13. BURZYNSKI, S. R., Kubove E., Burzynski, B. Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1. Drugs Exp. Clin. Res., 16: 361-369, 1990.
http://www.ncbi.nlm.nih.gov/m/pubmed/2152694/
� � � � � � � � � � � � � � � � �
1/1/1995 1st clinical trial
http://www.ncbi.nlm.nih.gov/m/pubmed/7528572
Oral sodium PHENYLBUTYRATE therapy in homozygous beta thalassemia:

a clinical trial
http://m.bloodjournal.hematologylibrary.org/content/85/1/43.full.pdf#page=1
Collins AF, Pearson HA, Giardina P, McDonagh KT, Brusilow SW, Dover GJ.
Blood. 1995 Jan 1;85(1):43-9.
Johns Hopkins University School of Medicine, Baltimore, MD.

References:

14. SAMID D, Shack S , Sherman L T

Phenylacetate:

A novel non-toxic inducer of tumor cell differentiation
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res 52:1988,1992
Cancer Res. 1992 Apr 1;52(7):1988-92.
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland.
http://cancerres.aacrjournals.org/content/52/7/1988
16. Fibach E, Prasanna P, Rodgers GP, SAMID D:

Enhanced fetal
hemoglobin production by phenylacetate and 4-PHENYLBUTYRATE in erythroid precursors derived from normal blood donors and patients with sickle cell anemia and P-thalassemia
http://www.ncbi.nlm.nih.gov/m/pubmed/7691251/
Blood 822203, 1993
Blood. 1993 Oct 1;82(7):2203-9.
Department of Hematology, Hadassah University Hospital, Jerusalem, Israel.

28. Dover GJ, Brusilow SW, SAMID D:

Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
N Engl JMed 327:569, 1992 (letter)
N Engl J Med. 1992 Aug 20;327(8):569-70.
� � � � � � � � � � � � � � � � �
7/1995 – Transcriptional upregulation of TGF-α by phenylacetate and PHENYLBUTYRATE is associated with differentiation of human melanoma cells.
http://www.ncbi.nlm.nih.gov/m/pubmed/7578983/
Liu L., Hudgins W. R., Miller A. C., Chen L. C., SAMID D.
http://www.sciencedirect.com/science/article/pii/S1043466685700610
Cytokine, 7: 449-456, 1995.
Cytokine Volume 7, Issue 5, July 1995, Pages 449–456
Cytokine. 1995 Jul;7(5):449-56.
a Clinical Pharmacology Branch, National Cancer Institute, Armed Forces of Radiation Research Institute, Bethesda, Maryland, USA
b Radiation Biochemistry Department, Armed Forces of Radiation Research Institute, Bethesda, Maryland, USA
http://dx.doi.org/10.1006/cyto.1995.0061
� � � � � � � � � � � � � � � � �
8/23/1996 – Activation of the human peroxisome proliferator-activated receptor by the antitumor agent phenylacetate and its analogues.
http://www.ncbi.nlm.nih.gov/m/pubmed/8759039/
Pineau T., Hudgins W. R., Liu L., Chen L. C., Sher T., Gonzalez F. J., SAMID D.
http://www.sciencedirect.com/science/article/pii/0006295296003401
Biochem. Pharmacol., 52: 659-667, 1996.
Biochemical Pharmacology
Volume 52, Issue 4, 23 August 1996, Pages 659–667
Biochem Pharmacol. 1996 Aug 23;52(4):659-67.
∗ Laboratory of Molecular Carcinogenesis U.S.A.
‡ Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD U.S.A.
§ Experimental Therapeutics Program, University of Virginia Cancer Center, Charlottesville, VA, U.S.A.
http://dx.doi.org/10.1016/0006-2952(96)00340-1
This work was supported, in part, by funds from the Elan Pharmaceutical Research Corporation through a Cooperative Research and Development Agreement (CACR-0139).
� � � � � � � � � � � � � � � � �
9/1996 – The differentiating agent phenylacetate increases prostate-specific antigen production by prostate cancer cells.
http://www.ncbi.nlm.nih.gov/m/pubmed/8827086/
Walls R., Thibault A., Liu L., Wood C., Kozlowski J. M., Figg W. D., Sampson M. L., Elin R. J., SAMID D.
Prostate, 29: 177-182, 1996.
Prostate. 1996 Sep;29(3):177-82.
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland, USA.
� � � � � � � � � � � � � � � � �
10/25/1996 – Transcriptional upregulation of γ globin by PHENYLBUTYRATE and analogous aromatic fatty acids.
http://www.ncbi.nlm.nih.gov/m/pubmed/8937430/
Hudgins W. R., Fibach E., Safaya S., Rieder R. F., Miller A. C., SAMID D.
http://www.sciencedirect.com/science/article/pii/0006295296004765
Biochem. Pharmacol., 52: 1227-1233, 1996.
Biochem Pharmacol. 1996 Oct 25;52(8):1227-33.
Biochemical Pharmacology
Volume 52, Issue 8, 25 October 1996, Pages 1227–1233
a Clinical Pharmacology Branch, National Cancer Institute, and Laboratory of Chemical Biology, National Institute of Diabetes, Digestive Diseases and Kidney Diseases, National Institutes Of Health, Bethesda, MD, U.S.A.
b Department of Hematology, Hadassah University Hospital, Jerusalem, Israel
c Department of Medicine, State University of New York Health Science Center, Brooklyn, NY, U.S.A.
d Radiation Biochemistry Department, Armed Forces Radiation Research Institute, Bethesda, MD, U.S.A.
e University of Virginia Cancer Center, Charlottesville, VA, U.S.A.
http://dx.doi.org/10.1016/0006-2952(96)00476-5

This work was supported by funds from the Elan Pharmaceutical Research Corp. and from the Israeli Science Foundation, administered by the Israel Academy of Sciences and Humanities.
� � � � � � � � � � � � � � � � �
1997 – The nuclear receptors PPARS as novel targets in differentiation therapy: activation by phenylacetate and PHENYLBUTYRATE .
SAMID D., Wells M., Kulkarni M., Lei L., Thibault A.
Anticancer Res., 17: 3927-3928, 1997.
� � � � � � � � � � � � � � � � �
8/2001 – A phase Idose escalation and bioavailability study of oral sodium PHENYLBUTYRATE in patients with refractory solid tumor malignancies
http://www.ncbi.nlm.nih.gov/m/pubmed/11489804
J Gilbert, S D Baker, … M A Carducci
http://m.clincancerres.aacrjournals.org/content/7/8/2292.long
Clin Cancer Res 7(8):2292-300 (2001), PMID.11489804

Clin Cancer Res. 2001 Aug;7(8):2292-300

References:

2. ↵ Liu L., Hudgins W. R., Miller A. C., Chen L. C., SAMID D. Transcriptional upregulation of TGF-α by phenylacetate and PHENYLBUTYRATE is associated with differentiation of human melanoma cells. Cytokine, 7: 449-456, 1995.
http://www.ncbi.nlm.nih.gov/m/pubmed/7578983/

http://www.sciencedirect.com/science/article/pii/S1043466685700610
3. ↵ Hudgins W. R., Fibach E., Safaya S., Rieder R. F., Miller A. C., SAMID D. Transcriptional upregulation of γ globin by PHENYLBUTYRATE and analogous aromatic fatty acids. Biochem. Pharmacol., 52: 1227-1233, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/8937430/

http://www.sciencedirect.com/science/article/pii/0006295296004765
5. ↵ SAMID D., Shack S., Myers C. E. Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate. J. Clin. Investig., 91: 2288-2295, 1991.
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/

http://m.jci.org/articles/view/116457
6. ↵ Pineau T., Hudgins W. R., Liu L., Chen L. C., Sher T., Gonzalez F. J., SAMID D. Activation of the human peroxisome proliferator-activated receptor by the antitumor agent phenylacetate and its analogues. Biochem. Pharmacol., 52: 659-667, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/8759039/

http://www.sciencedirect.com/science/article/pii/0006295296003401
15. ↵ Walls R., Thibault A., Liu L., Wood C., Kozlowski J. M., Figg W. D., Sampson M. L., Elin R. J., SAMID D. The differentiating agent phenylacetate increases prostate-specific antigen production by prostate cancer cells. Prostate, 29: 177-182, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/8827086/
20. ↵ SAMID D., Wells M., Kulkarni M., Lei L., Thibault A. The nuclear receptors PPARS as novel targets in differentiation therapy: activation by phenylacetate and PHENYLBUTYRATE. Anticancer Res., 17: 3927-3928, 1997.
� � � � � � � � � � � � � � � � �
10/2001 – A Phase I clinical and pharmacological evaluation of sodium PHENYLBUTYRATE on an 120-h infusion schedule
M A Carducci, J Gilbert, … R C Donehower
Clin Cancer Res 7(10):3047-55 (2001), PMID.11595694
http://www.ncbi.nlm.nih.gov/m/pubmed/11595694
Clin Cancer Res. 2001 Oct;7(10):3047-55.
http://m.clincancerres.aacrjournals.org/content/7/10/3047.long
Division of Medical Oncology, The Johns Hopkins Oncology Center, Baltimore, MD, USA.

References:

10. ↵ SAMID D., Shack S., Myers C. E. Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate. J. Clin. Investig., 91: 2288-2295, 1991.
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/

http://m.jci.org/articles/view/116457

http://m.jci.org/articles/view/116457/pdf.mobile
11. ↵ SAMID D., Shack S., Sherman L. T. Phenylacetate:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res., 52: 1988-1992, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
13. ↵ Shack S., Miller A., Liu L., Prasanna P., Thilbault A., SAMID D. Vulnerability of multi-drug resistant tumor cells to the aromatic fatty acids phenylacetate and PHENYLBUTYRATE. Clin. Cancer Res., 2: 865-872, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/9816242/

http://m.clincancerres.aacrjournals.org/content/2/5/865.abstract

http://m.clincancerres.aacrjournals.org/content/2/5/865.full.pdf

http://clincancerres.aacrjournals.org/content/2/5/865
14. ↵ SAMID D., Yeh A., Prasanna P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate. Blood, 80: 1576-1581, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
17. ↵ SAMID D., Ram Z., Hudgins W. R., Shack S., Liu L., Walbridge S., Oldfield E. H., Myers C. E. Selective activity of phenylacetate against malignant gliomas:

resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1994.
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/

http://cancerres.aacrjournals.org/content/54/4/891/
18. ↵ Fibach E., Prasanna P., Rodgers G. P., SAMID D. Enhanced fetal hemoglobin production by phenylacetate and 4-PHENYLBUTYRATE in erythroid precursors derived from normal donors and patients with sickle cell anemia and β-thalassemia. Blood, 82: 2203-2209, 1993.
http://www.ncbi.nlm.nih.gov/m/pubmed/7691251/

http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.abstract

http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.full.pdf
23. ↵ Liu L., Hudgins W. R., Miller A. C., Chen L. C., SAMID D. Transcriptional upregulation of TGF-α by phenylacetate and PHENYLBUTYRATE is associated with differentiation of human melanoma cells. Cytokine, 7: 449-456, 1995.
http://www.ncbi.nlm.nih.gov/m/pubmed/7578983/

http://www.sciencedirect.com/science/article/pii/S1043466685700610
24. ↵ Hudgins W. R., Fibach E., Safaya S., Reider R. F., Miller A. C., SAMID D. Transcriptional upregulation of γ globin by PHENYLBUTYRATE and analogous aromatic fatty acids. Biochem. Pharmacol., 52: 1227-1233, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/8937430/

http://www.sciencedirect.com/science/article/pii/0006295296004765
27. ↵ Pineau T., Hudgins W. R., Liu L., Chen L. C., Sher T., Gonzalez F. J., SAMID D. Activation of human peroxisome proliferator activator receptor by the antitumor agent phenylacetate and its analogs. Biochem. Pharmacol., 52: 659-667, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/8759039/

http://www.sciencedirect.com/science/article/pii/0006295296003401
33. ↵ Walls R., Thilbault A., Liu L., Wood C., Kozlowski J. M., Figg W. D., Sampson M. L., Elin R. J., SAMID D. The differentiating agent phenylacetate increases prostate-specific antigen production by prostate cancer cells. Prostate, 29: 177-182, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/8827086/
40. ↵ Thibault A., Cooper M. R., Figg W. D., Venzon D. J., Sartor A. O., Tompkins A. C., Weinberger M S., Headlee D. J., McCall N. A., SAMID D., et al A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Res., 54: 1690-1694, 1994.
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/

http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract

http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf

http://cancerres.aacrjournals.org/content/54/7/1690
41. ↵ Piscitelli S. C., Thibault A., Figg W. D., Tompkins A. C., Headlee D., Lieberman R., SAMID D., Myers C. E. Disposition of PHENYLBUTYRATE and its metabolites, phenylacetate and phenylacetylglutamine. J. Clin. Pharmacol., 35: 368-373, 1995.
http://www.ncbi.nlm.nih.gov/m/pubmed/7650225/

http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1995.tb04075.x/abstract;jsessionid=43600D49608A093971D675F3DB5FF13D.d01t03
47. ↵ SAMID D., Wells M., Kulkarni M., Lei L., Thibault A. The nuclear receptors PPARS as novel targets in differentiation therapy:

activation by phenylacetate and PHENYLBUTYRATE. Anticancer Res., 17: 3927-3928, 1997
� � � � � � � � � � � � � � � � �
4/2005 – Oral sodium PHENYLBUTYRATE in patients with recurrent malignant gliomas:

A dose escalation and pharmacologic study

Neuro-oncol. 2005 April; 7(2): 177–182 PMCID: PMC1871887

PDF:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1871887/pdf/neu0702p177.pdf
References:

3. Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Ames MM, Tong WP, Lim S, Figg WD

Phase II study of anti-neoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma

Mayo Clin Proc. 1999;74:137–145

12. Gore SD, SAMID D, Weng LJ

Impact of the putative differentiating agents sodium PHENYLBUTYRATE and sodium phenylacetate on proliferation, differentiation, and apoptosis of primary neoplastic myeloid cells

Clin Cancer Res. 1997a;3:1755–1762

17. Hudgins WR, Pineau T, Sher T, Gonzales FJ, Myers CE, SAMID D

Anticancer activity of phenylacetate and related aromatic fatty acids:

Correlation with lipophilicity and capacity to activate nuclear receptor

Proc Am Assoc Can Res. 1994;35:391. (abstract 2332)

19. SAMID D, Shack S, Myers CE

Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate

J Clin Invest. 1993;91:2288–2295

20. SAMID D, Ram Z, Hudgins WR, Shack S, Liu L, Walbridge S, Oldfield EH, Myers CE

Selective activity of phenylacetate against malignant gliomas:

Resemblance to fetal brain damage in phenylketonuria

Cancer Res. 1994;54:891–895

21. Sidell N, Wada R, Han G, Chang B, Shack S, Moore T, SAMID D

Phenylacetate synergizes with retinoic acid in inducing the differentiation of human neuroblastoma cells

Int J Cancer. 1995;60:507–514
� � � � � � � � � � � � � � � � �
4/2005 – Oral sodium PHENYLBUTYRATE in patients with recurrent malignant gliomas:

A dose escalation and pharmacologic study

Neuro-oncol. 2005 April; 7(2): 177–182 PMCID: PMC1871887

PDF:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1871887/pdf/neu0702p177.pdf
References:

3. Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Ames MM, Tong WP, Lim S, Figg WD
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II study of anti-neoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
Mayo Clin Proc. 1999;74:137–145
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Mayo Clinic Proceedings
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Mayo Clin Proc 74(2):9 (1999)
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf
DOI: 10.4065/74.2.137
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 1999; 74: 137–45
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references

http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29

http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
12. Gore SD, SAMID D, Weng LJ

Impact of the putative differentiating agents sodium PHENYLBUTYRATE and sodium phenylacetate on proliferation, differentiation, and apoptosis of primary neoplastic myeloid cells

Clin Cancer Res. 1997a;3:1755–1762
http://www.ncbi.nlm.nih.gov/m/pubmed/9815560/

http://m.clincancerres.aacrjournals.org/content/3/10/1755.abstract

http://m.clincancerres.aacrjournals.org/content/3/10/1755.full.pdf

http://clincancerres.aacrjournals.org/content/3/10/1755
17. Hudgins WR, Pineau T, Sher T, Gonzales FJ, Myers CE, SAMID D

Anticancer activity of phenylacetate and related aromatic fatty acids:

Correlation with lipophilicity and capacity to activate nuclear receptor

Proc Am Assoc Can Res. 1994;35:391. (abstract 2332)

19. SAMID D, Shack S, Myers CE

Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of phenylacetate

J Clin Invest. 1993;91:2288–2295
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/

http://m.jci.org/articles/view/116457
20. SAMID D, Ram Z, Hudgins WR, Shack S, Liu L, Walbridge S, Oldfield EH, Myers CE

Selective activity of phenylacetate against malignant gliomas:

Resemblance to fetal brain damage in phenylketonuria

Cancer Res. 1994;54:891–895
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/

http://cancerres.aacrjournals.org/content/54/4/891
21. Sidell N, Wada R, Han G, Chang B, Shack S, Moore T, SAMID D

Phenylacetate synergizes with retinoic acid in inducing the differentiation of human neuroblastoma cells

Int J Cancer. 1995;60:507–514
http://www.ncbi.nlm.nih.gov/m/pubmed/7829265/
� � � � � � � � � � � � � � � � �
4/2007Phase I dose escalation clinical trial of PHENYLBUTYRATE sodium administered twice daily to patients with advanced solid tumors
Luis H LH Camacho, Jon J Olson, … Mark G MG Malkin
Invest New Drugs 25(2):131-8 (2007), PMID.17053987

Investigational New Drugs
April 2007, Volume 25, Issue 2, pp 131-138
http://www.ncbi.nlm.nih.gov/m/pubmed/17053987

http://link.springer.com/article/10.1007%2Fs10637-006-9017-4
References:

4. SAMID D, Shack S, Sherman LT

(1992)

Phenylacetate:

a novel nontoxic inducer of tumor cell differentiation

Cancer Res 52(7):1988–1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res 52:1988,1992
Cancer Res. 1992 Apr 1;52(7):1988-92.
http://cancerres.aacrjournals.org/content/52/7/1988
5. DiGiuseppe JA, Weng LJ, Yu KH, Fu S, Kastan MB, SAMID D, et al

(1999)

PHENYLBUTYRATE-induced G1 arrest and apoptosis in myeloid leukemia cells:

structure-function analysis

Leukemia 13(8):1243–1253
http://www.ncbi.nlm.nih.gov/m/pubmed/10450753/
7. SAMID D, Hudgins WR, Shack S, Liu L, Prasanna P, Myers CE

(1997)

Phenylacetate and PHENYLBUTYRATE as novel, nontoxic differentiation inducers

Adv Exp Med Biol 400A:501–505
http://www.ncbi.nlm.nih.gov/m/pubmed/9547596/
20. Boudoulas S, Lush RM, McCall NA, SAMID D, Reed E, Figg WD

(1996)

Plasma protein binding of phenylacetate and PHENYLBUTYRATE, two novel antineoplastic agents

Ther Drug Monit 18(6):714–720
http://www.ncbi.nlm.nih.gov/m/pubmed/8946671/
24. Thibault A, SAMID D, Cooper MR, Figg WD, Tompkins AC, Patronas N, et al

(1995)

Phase I study of phenylacetate administered twice daily to patients with cancer

Cancer 75(12):2932–2938
http://www.ncbi.nlm.nih.gov/m/pubmed/7773944/
30. Stockhammer G, Manley GT, Johnson R, Rosenblum MK, SAMID D, Lieberman FS

(1995)

Inhibition of proliferation and induction of differentiation in medulloblastoma- and astrocytoma-derived cell lines with phenylacetate

J Neurosurg 83(4):672–681
http://www.ncbi.nlm.nih.gov/m/pubmed/7674018/
32. Ram Z, SAMID D, Walbridge S, Oshiro EM, Viola JJ, Tao-Cheng JH, et al

(1994)

Growth inhibition, tumor maturation, and extended survival in experimental brain tumors in rats treated with phenylacetate

Cancer Res 54(11):2923–2927
http://www.ncbi.nlm.nih.gov/m/pubmed/8187079/

http://m.cancerres.aacrjournals.org/content/54/11/2923.full.pdf

http://m.cancerres.aacrjournals.org/content/54/11/2923.abstract

http://cancerres.aacrjournals.org/content/54/11/2923
33. SAMID D, Yeh TJ, Shack S

(1991)

Interferon in combination with antitumourigenic phenyl derivatives: potentiation of IFN alpha activity in-vitro

Br J Haematol 79(Suppl 1):81–83
http://www.ncbi.nlm.nih.gov/m/pubmed/1931716/
34. Gorospe M, Shack S, Guyton KZ, SAMID D, Holbrook NJ

(1996)

Up-regulation and functional role of p21Waf1/Cip1 during growth arrest of human breast carcinoma MCF-7 cells by phenylacetate

Cell Growth Differ 7(12):1609–1615
http://www.ncbi.nlm.nih.gov/m/pubmed/8959328/
35. Bar-Ner M, Thibault A, Tsokos M, Magrath IT, SAMID D

(1999)

PHENYLBUTYRATE induces cell differentiation and modulates Epstein-Barr virus gene expression in Burkitt’s lymphoma cells

Clin Cancer Res 5(6):1509–1516
http://www.ncbi.nlm.nih.gov/m/pubmed/10389940/

http://m.clincancerres.aacrjournals.org/content/5/6/1509.abstract

http://m.clincancerres.aacrjournals.org/content/5/6/1509.long

http://clincancerres.aacrjournals.org/content/5/6/1509
36. Shack S, Miller A, Liu L, Prasanna P, Thibault A, SAMID D

(1996)

Vulnerability of multidrug-resistant tumor cells to the aromatic fatty acids phenylacetate and PHENYLBUTYRATE

Clin Cancer Res 2(5):865–872
http://www.ncbi.nlm.nih.gov/m/pubmed/9816242/

http://m.clincancerres.aacrjournals.org/content/2/5/865.abstract

http://m.clincancerres.aacrjournals.org/content/2/5/865.full.pdf

http://clincancerres.aacrjournals.org/content/2/5/865
37. SAMID D, Yeh A, Prasanna P

(1992)

Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate

Blood 80(6):1576–1581
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
38. Fibach E, Prasanna P, Rodgers GP, SAMID D

(1993)

Enhanced fetal hemoglobin production by phenylacetate and 4-PHENYLBUTYRATE in erythroid precursors derived from normal donors and patients with sickle cell anemia and beta-thalassemia

Blood 82(7):2203–2209
http://www.ncbi.nlm.nih.gov/m/pubmed/7691251/

http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.abstract

http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.full.pdf
� � � � � � � � � � � � � � � � �
4/2009Phase 2 study of sodium PHENYLBUTYRATE in ALS.
Merit E Cudkowicz, Patricia L Andres, … THE NORTHEAST ALS AND THE NATIONAL VA ALS RESEARCH CONSORTIUMS
Amyotroph Lateral Scler 10(2):99-106 (2009), PMID.18688762
Amyotroph Lateral Scler. 2009 Apr;10(2):99-106. doi: 10.1080/17482960802320487
http://www.ncbi.nlm.nih.gov/m/pubmed/18688762

http://informahealthcare.com/doi/pdf/10.1080/17482960802320487?noFrame=true

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1871887
� � � � � � � � � � � � � � � � �
10/1/2009 – A Phase I Dose-Finding Study of 5-Azacytidine in Combination with Sodium PHENYBUTYRATE in Patients with Refractory Solid Tumors
J Lin, J Gilbert, … M A Carducci
Clin Cancer Res 15(19):6241-6249 (2009), PMID.19789320, PMCID PMC2845396
Clin Cancer Res. 2009 Oct 1;15(19):6241-9. doi: 10.1158/1078-0432.CCR-09-0567. Epub 2009 Sep 29
http://www.ncbi.nlm.nih.gov/m/pubmed/19789320

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2845396
References:

24. Robertson KD, Hayward SD, Ling PD, SAMID D, Ambinder RF

Transcriptional activation of the Epstein-Barr virus latency C promoter after 5-azacytidine treatment:

evidence that demethylation at a single CpG site is crucial

Mol Cell Biol. 1995;15:6150–9
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC230866/
� � � � � � � � � � � � � � � � �
7/2010Phase 2 comparison of a novel ammonia scavenging agent with sodium PHENYLBUTYRATE in patients with urea cycle disorders:

Safety, pharmacokinetics and ammonia control
http://www.ncbi.nlm.nih.gov/m/pubmed/20382058/
Brendan Lee, William Rhead, … Susan A Berry
Mol Genet Metab 100(3):8 (2010), PMID.20382058, PMCID PMC2905228
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905228/
Mol Genet Metab. 2010 Jul;100(3):221-8. doi: 10.1016/j.ymgme.2010.03.014. Epub 2010 Mar 23.
Baylor College of Medicine, Houston, TX, USA.

http://www.sciencedirect.com/science/article/pii/S1096719210001058
a Baylor College of Medicine, Houston, TX, United States
b Howard Hughes Medical Institute, TX, United States
c Pediatrics, Medical College of Wisconsin, Milwaukee, WI, United States
d Mount Sinai School of Medicine, New York, NY, United States
e Hyperion Therapeutics, Inc., South San Francisco, CA, United States
f Pharsight Corp., Montreal, Quebec, Canada
g Chiltern, Wilmington, NC, United States
h Division of Genetics and Metabolism, University of Minnesota, Minneapolis, MN, United States
http://dx.doi.org/10.1016/j.ymgme.2010.03.014

Phenylacetylglutamine (PG or PAG)

Dvorit D. SAMID learned about PHENYLACETYLGLUTAMINATE (PG or PAG) from Burzynski
� � � � � � � � � � � � � � � � �
PHENYLACETYLGLUTAMINATE (PG or PAG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1
� � � � � � � � � � � � � � � � �
Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10
� � � � � � � � � � � � � � � � �
AS2-1=4:1 mixture of Phenylacetic Acid (PA) and PHENYLACETYLGLUTAMINE (PAG or PG)
� � � � � � � � � � � � � � � � �
Antineoplaston AS2-5 = PHENYLACETYLGLUTAMINE (PAG or PG)
� � � � � � � � � � � � � � � � �
National Cancer Institute (NCI)
at the National Institutes of Health (NIH) Antineoplastons
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
� � � � � � � � � � � � � � � � �
4/1994 A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer
SAMID D
phase I…study of intravenous Phenylacetate=PN in patients with cancer
http://www.ncbi.nlm.nih.gov/pubmed/8137283
Cancer Res. 1994 Apr 1;54(7):1690-4
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
Cancer Res April 1, 1994 54; 1690
http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pd
Cancer Res 1994;54:1690-1694
http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract
Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
http://cancerres.aacrjournals.org/content/54/7/1690
PN (Phenylacetate) elimination was accounted for by conversion to PHENYLACETYLGLUTAMINATE (PG or PAG) … excreted in the urine
http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf
A A Thibault, …, D D SAMID et al.
Cancer Res 54(7):1690-4 (1994), PMID.8137283
Burzynski Reference: 13
� � � � � � � � � � � � � � � � �
4/1995 Disposition of phenylbutyrate and its metabolites, phenylacetate and PHENYLACETYLGLUTAMINATE
SAMID D et al
Disposition of PB and its metabolites PN and PG (PAG)
Burzynski
http://www.ncbi.nlm.nih.gov/pubmed/7650225
J Clin Pharmacol. 1995 Apr;35(4):368-73
http://www.ncbi.nlm.nih.gov/m/pubmed/7650225
J Clin Pharmacol 35(4):368-73 (1995), PMID.7650225
http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1995.tb04075.x/abstract;jsessionid=314D898507527C2793B578096D7E3C0F.d01t03
Article first published online: 8 MAR 2013
DOI: 10.1002/j.1552-4604.1995.tb04075.x
Pharmacy Department, National Institutes of Health, Bethesda, Maryland, USA
Dvorit SAMID … A A Thibault, … et al.

A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
A A Thibault, …, D D SAMID et al.
Cancer Res 54(7):1690-4 (1994), PMID.8137283
Cancer Res. 1994 Apr 1;54(7):1690-4
Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
phenylacetate elimination was accounted for by conversion to phenylacetylglutamine, which was excreted in the urine
http://cancerres.aacrjournals.org/content/54/7/1690
References: 8 – 13

Phenylacetate (PN)

Dvorit D. SAMID learned about PHENYLACETATE (PN) from Burzynski
� � � � � � � � � � � � � � � � �
Phenylacetylglutaminate (PAG or PG) and PHENYLACETATE (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1
� � � � � � � � � � � � � � � � �
Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10
� � � � � � � � � � � � � � � � �
AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and Phenylacetylglutamine (PAG or PG)
� � � � � � � � � � � � � � � � �
National Cancer Institute (NCI)
at the National Institutes of Health (NIH)
Antineoplastons
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
� � � � � � � � � � � � � � � � �
PHENYLACETATE (PN)
Year – Pubmed (29,686 entries)
1883 1st entry
1994 Phase 1
1999 Phase 2
2013 latest
� � � � � � � � � � � � � � � � �
2/8/2013 – Metabolic improvements in intrahepatic porto-systemic venous shunt presenting various metabolic abnormalities by 4-PHENYLACETATE
http://www.ncbi.nlm.nih.gov/pubmed/23399721/
Clin Chim Acta. 2013 Apr 18;419:52-6. doi: 10.1016/j.cca.2013.01.016. Epub 2013 Feb 8.
http://www.ncbi.nlm.nih.gov/m/pubmed/23399721/
Department of Pediatrics, Takarazuka City Hospital, Takarazuka, Japan.
k2.dion.ne.jp
Clin Chim Acta. 2013 Feb 8. pii: S0009-8981(13)00038-7. doi: 10.1016/j.cca.2013.01.016. [Epub ahead of print]
� � � � � � � � � � � � � � � � �
http://cancerres.aacrjournals.org/search?submit=yes&submit=Go&y=0&fulltext=Samid&x=0&format=standard&hits=80&sortspec=reverse-date&submit=Go

http://cancerres.aacrjournals.org/search?submit=yes&y=0&fulltext=%22Dvorit+Samid%22&x=0&format=standard&hits=80&sortspec=reverse-date&submit=Go
� � � � � � � � � � � � � � � � �
4/1/1992PHENYLACETATE
Cancer Res 1992;52:1988-1992
PHENYLACETATE:
A Novel Nontoxic Inducer of Tumor Cell Differentiation
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
…. PAG (BRI, Houston, TX)
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534
Phenylacetic acid (Sigma, St. Louis, MO) and PAG (BRI, Houston, TX)
http://cancerres.aacrjournals.org/content/52/7/1988
(BRI = Burzynski Research Institute)
http://cancerres.aacrjournals.org/content/52/7/1988.full.pdf
Phenylacetylglutaminate (PAG or PG) and PHENYLACETATE (PN) are metabolites of Phenylbutyrate (PB) …..
http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf#page=1
Dvorit SAMID
Cancer Res. 1992 Apr 1;52(7):1988-92
Clinical Pharmacology Branch, Division of Cancer Treatment, National Cancer Institute, Bethesda, Maryland [D. S., S. S.] and Department of Pathology, Uniformed Services University of the Health Sciences, Bethesda, Maryland [L. T. S.]

↵1 Supported by Elan Pharmaceutical Corporation Grant G174ED.
SAMID, D., Shack, S., and Sherman, l.. T.

(Cancer Res., 52: 1988-1992, 1992
Cancer Res 1992;52:1988-1992

Reference:

12. Rimoldi, D., Srikantan, V., Wilson, V. L., Bassin, R. H., and SAMID, D.
Increased sensitivity of nontumorigenic fibroblasts expressing ras or myc oncogenes to malignant transformation induced by 5-aza-2′-deoxycytidine.
Cancer Res., 51: 1-7, 1991.
http://www.ncbi.nlm.nih.gov/pubmed/1703037/

http://www.ncbi.nlm.nih.gov/m/pubmed/1703037/

http://m.cancerres.aacrjournals.org/content/51/1/324.abstract

http://m.cancerres.aacrjournals.org/content/51/1/324.full.pdf

http://cancerres.aacrjournals.org/content/51/1/324
6. SAMID et al., unpublished observations.
� � � � � � � � � � � � � � � � �
9/15/1992 – Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with PHENYLACETATE

http://www.ncbi.nlm.nih.gov/pubmed/1381630/
SAMID, D., Yeh, A.. and Prasanna. P.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
Blood, 80: 1576-1581. 1992
http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract
Blood. 1992 Sep 15;80(6):1576-81.
http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD

References:

15. SAMID D, Shack S, Ti-Sherman L PHENYLACETATE-A novel nontoxic inducer of tumor cell differentiation. Cancer Res 52:1988, 1992
http://www.ncbi.nlm.nih.gov/pubmed/1372534/

http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
20. SAMID D, Flessate DM, Friedman RM: Interferon-induced
revertants of ras-transformed cells: Resistance to transformation by specific oncogenes and retransformation by 5-azacytidine. Mol Cell Biol 7:2196, 1987
http://www.ncbi.nlm.nih.gov/pubmed/2439904/

http://www.ncbi.nlm.nih.gov/m/pubmed/2439904/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365343/

http://mcb.asm.org/content/7/6/2196.full.pdf
21. Rimoldi D, Srikantan V, Wilson VL, Bassin RH, SAMID D: Increased sensitivity of nontumorigenic fibroblasts expressing ras or myconcogenes to malignant transformation induced by 5-aza-2‘- deoxycytidine. Cancer Res 51:324, 1991
http://www.ncbi.nlm.nih.gov/pubmed/1703037/

http://www.ncbi.nlm.nih.gov/m/pubmed/1703037/

http://m.cancerres.aacrjournals.org/content/51/1/324.abstract

http://m.cancerres.aacrjournals.org/content/51/1/324.full.pdf

http://cancerres.aacrjournals.org/content/51/1/324
34. Dover GJ, Brusilow S, SAMID D: Increased fetal hemoglobin in patients receiving sodium 4-phenylbutyrate. N Engl J Med 327569, 1992
http://www.ncbi.nlm.nih.gov/pubmed/1378939/

http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
� � � � � � � � � � � � � � � � �
5/1993 – Selective growth arrest and maturation of prostate cancer cells in vitro bv nontoxic, pharmacological concentrations of PHENYLACETATE

SAMID. D., Shack. S., and Myers, C. E.

J. Clin. Invest., 91: 2288-2295, 1993
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
J Clin Invest. 1993 May; 91(5): 2288–2295.
doi: 10.1172/JCI116457
PMCID: PMC288233

This study was supported by Elan Pharmaceutical Corporation grant G174ED.

References:

9. SAMID, D., D.M. Flesate, and R.M. Friedman. 1987. Interferon-induced revertants of ras-transformed cells: resistance to transformation by specific oncogenes and retransformation by 5-azacytidine. Mol. Cel. Biol. 7:2196-2200.
http://www.ncbi.nlm.nih.gov/m/pubmed/2439904/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365343/

http://mcb.asm.org/content/7/6/2196.full.pdf
13. SAMID, D., S. Shack, and L. T. Sherman. 1992. PHENYLACETATE:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res. 52:1988-1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
14. SAMID, D., A. Yeh,and P. Prasanna. 1992. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with PHENYLACETATE. Blood. 80:1576-1581.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
17. Dover, G.J., S. Brusilow, and D. SAMID. 1992. Increased fetal hemoglobin in patients receiving sodium 4-phenylbutyrate. N. Engl. J. Med. 327:569-570.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/

http://www.nejm.org/doi/full/10.1056/NEJM199208203270818
33. Mandler, R., D. Rimoldi, K. Kariko, and D. SAMID. 1991. Urokinase-type plasminogen activator in experimental metastasis of human osteosarcoma cells. Cancer J. 4:316-321.

34. Rimoldi, D., V. Srikantan, V. L. Wilson, R. H. Bassin, and D. SAMID. 1991. Increased sensitivity of nontumerogenic fibroblasts expressing ras or myc oncogenes to malignant transformation induced by 5-aza-2-deoxycytidine.
CancerRes.51:1-7.
http://www.ncbi.nlm.nih.gov/m/pubmed/1703037/

http://m.cancerres.aacrjournals.org/content/51/1/324.abstract

http://m.cancerres.aacrjournals.org/content/51/1/324.full.pdf

http://cancerres.aacrjournals.org/content/51/1/324
� � � � � � � � � � � � � � � � �
2/15/1994 – Selective Activity of PHENYLACETATE against Malignant Gliomas:

Resemblance to Fetal Brain Damage in Phenylketonuria
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/
SAMID D., et al.
http://cancerres.aacrjournals.org/content/54/4/891
Cancer Res., 54: 891-895, 1994
http://cancerres.aacrjournals.org/content/54/4/891.full.pdf?sid=0831b0b7-6f89-4d0d-941e-03f12eebc71a
Cancer Res February 15, 1994 54:891-895
Clinical Pharmacology Branch, Division of Cancer Treatment, National Cancer Institute and Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland

References:

2. SAMID, D., Shack, S., and Sherman, l.. T. PHENYLACETATE:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res., 52: 1988-1992, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
8. SAMID, D., Yeh, A.. and Prasanna. P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with PHENYLACETATE. Blood, 80: 1576-1581. 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
9. SAMID. D., Shack. S., and Myers, C. E. Selective growth arrest and maturation of prostate cancer cells in vitro by nontoxic, pharmacological concentrations of PHENYLACETATE. J. Clin. Invest., 91: 2288-2295, 1993.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
J Clin Invest. 1993 May; 91(5): 2288–2295.
doi: 10.1172/JCI116457
PMCID: PMC288233

6. A. Thibault et al., A phase I and pharmacokinetic study of intravenous PHENYLACETATE in patients with cancer, submitted for publication.
� � � � � � � � � � � � � � � � �
4/1/1994 – A phase I and pharmacokinetic study of intravenous PHENYLACETATE in patients with cancer
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
A A Thibault, …, D D SAMID et al.
Cancer Res 54(7):1690-4 (1994), PMID.8137283
http://cancerres.aacrjournals.org/content/54/7/1690.full.pdf?sid=78d246d7-a4ee-4980-bdaf-b299dc98cbe8
Cancer Res April 1, 1994 54:1690
http://cancerres.aacrjournals.org/content/54/7/1690
Cancer Res. 1994 Apr 1;54(7):1690-4.
http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract
Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland.
http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf
↵1 This study was supported in part by a grant from Elan Pharmaceutical Research Co.

References:

8. SAMID, A., Shack, S., and Sherman, L. T. PHENYLACETATE:

a novel nontoxic inducer of tumor cell differentiation. Cancer Res., 52: 1988-1992, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
9. SAMID, D., Yen, A., and Prasana, P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with PHENYLACETATE. Blood, 80: 1576-1581, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
10. SAMID, D., Shack, S., and Myers, C. E. Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of PHENYLACETATE. J. Clin. Invest., 91: 2288-2295, 1993.
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/

http://m.jci.org/articles/view/116457
11. SAMID. D., Ram, Z., Hudgins, W. R., Shack, S., Liu, L., Walbridge, S., Oldfield, E. H., Myers, C. E. Selective activity of PHENYLACETATE against malignant gliomas:

resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1994.
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/

http://cancerres.aacrjournals.org/content/54/4/891
12. Dover, G. J., Brusilow, S., and SAMID, D. Increased fetal hemoglobin in patients
receiving sodium 4-phenylbutyrate. N. Engl. J. Med., 327: 569-570, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
13. BURZYNSKI, S. R., Kubove E., Burzynski, B. Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1. Drugs Exp. Clin. Res., 16: 361-369, 1990.
http://www.ncbi.nlm.nih.gov/m/pubmed/2152694/
� � � � � � � � � � � � � � � � �
6/1/1994 – Growth inhibition, tumor maturation, and extended survival in experimental brain tumors in rats treated with PHENYLACETATE.
http://www.ncbi.nlm.nih.gov/m/pubmed/8187079/
Ram Z, SAMID D, Walbridge S, et al:
http://m.cancerres.aacrjournals.org/content/54/11/2934.abstract?ijkey=03bc67e581ef77536842806b949046916458d548&keytype2=tf_ipsecsha
Cancer Res 54:2934-2927, 1994
http://m.cancerres.aacrjournals.org/content/54/11/2923.abstract
Cancer Res. 1994 Jun 1;54(11):2923-7.
http://m.cancerres.aacrjournals.org/content/54/11/2923.full.pdf
Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, Maryland.
http://cancerres.aacrjournals.org/content/54/11/2923
References:

1. SAMID, D., Shack, S., and Sherman, L. 1. PHENYLACETATE: a novel nontoxic inducer of
tumor cell differentiation. Cancer Res., 52: 1988-92, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://cancerres.aacrjournals.org/content/52/7/1988
2. SAMID, D., Yeh, A., and Prasanna, P. Induction of erythroid differentiation and fetal
hemoglobin production in human leukemic cells treated with PHENYLACETATE. Blood, 80: 1576-81, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
3. SAMID, D., Shack, S., and Myers, C. E. Selective growth arrest and phenotypic
reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations
of PHENYLACETATE. J. Clin. Invest., 91: 2288-2295, 1993.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
4. SAMID, D., Ram, Z., Hudgins, W. R., Shack, S., Liu, L., Waibridge, S., Oldfield, E. H., and Myers, C. E. Selective activity of PHENYLACETATE against malignant gliomas: resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1993.
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/
9. BURZYNSKI, S. R., Kubove, E., and Burzynski, B. Treatment of hormonally refractory
cancer of the prostate with antineoplaston AS2-1. Drugs Exp. Clin. Res., 16: 361-9, 1990.
http://www.ncbi.nlm.nih.gov/m/pubmed/2152694/
� � � � � � � � � � � � � � � � �
2/8/1995PHENYLACETATE synergizes with retinoic acid in inducing the differentiation of human neuroblastoma cells.
http://www.ncbi.nlm.nih.gov/m/pubmed/7829265/
Sidell N, Wada R, Han G, et al: (SAMID D)
http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910600414/abstract
Int J Cancer 60:507-514, 1995
Int J Cancer. 1995 Feb 8;60(4):507-14.
International Journal of Cancer
Volume 60, Issue 4, pages 507–514, 8 February 1995
Article first published online: 17 JUL 2006
DOI: 10.1002/ijc.2910600414
Department of Pathology and Laboratory Medicine (Neuropathology), UCLA School of Medicine.
� � � � � � � � � � � � � � � � �
4/1995 – Disposition of phenylbutyrate and its metabolites, PHENYLACETATE and phenylacetylglutamine.
http://www.ncbi.nlm.nih.gov/m/pubmed/7650225/
Piscitelli SC, Thibault A, Figg WD, et al: (SAMID D)
http://m.jcp.sagepub.com/content/35/4/368.abstract?ijkey=74bff0d86ce76b404728762fe2a1bfde1641fa41&keytype2=tf_ipsecsha
J Clin Pharmacol 35:368-373, 1995 Abstract
http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1995.tb04075.x/abstract;jsessionid=DFDEF1599D764E2845EC2897269C198B.d01t01
The Journal of Clinical Pharmacology
Volume 35, Issue 4, pages 368–373, April 1995
http://jcp.sagepub.com/content/35/4/368
Article first published online: 8 MAR 2013
DOI: 10.1002/j.1552-4604.1995.tb04075.x
� � � � � � � � � � � � � � � � �
6/15/1995Phase Istudy of PHENYLACETATE administered twice daily to patients with cancer
http://www.ncbi.nlm.nih.gov/m/pubmed/7773944
A A Thibault, D D SAMID, … C E CE Myers
Cancer 75(12):2932-8 (1995), PMID.7773944
Cancer. 1995 Jun 15;75(12):2932-8
Clinical Pharmacology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
� � � � � � � � � � � � � � � � �
9/27/1995 – Increased susceptibility of ras-transformed cells to PHENYLACETATE is associated with inhibition of p21ras isoprenylation and phenotypic reversion.
http://www.ncbi.nlm.nih.gov/m/pubmed/7558439/
Shack S, Chen L-C, Miller AC, et al: (SAMID D)
http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/abstract
Int J Cancer 63:124-129, 1995
Int J Cancer. 1995 Sep 27;63(1):124-9.
http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/references
International Journal of Cancer
Volume 63, Issue 1, Article first published online: 17 JUL 2006
DOI: 10.1002/ijc.2910630122
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD, USA.
� � � � � � � � � � � � � � � � �
10/1995 – Inhibition of proliferation and induction of differentiation in medulloblastoma and astrocytoma-derived cell lines with PHENYLACETATE.
http://www.ncbi.nlm.nih.gov/m/pubmed/7674018/
Stockhammer G, Manley GT, Johnson R, et al: (SAMID D)
J Neurosurg 83:672-681, 1995
J Neurosurg. 1995 Oct;83(4):672-81.
Cotzias Laboratory of Neuro-Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
� � � � � � � � � � � � � � � � �
10/12/1995 – Cytostatic activity of PHENYLACETATE and derivatives against tumor cells:

Correlation with lipophilicity and inhibition of protein prenylation.
http://www.ncbi.nlm.nih.gov/m/pubmed/7488244/
Hudgins WR, Shack S, Myers CE, et al: (SAMID D)
http://www.sciencedirect.com/science/article/pii/0006295295020133
Biochem Pharmacol 50:1273-1279, 1995
Biochem Pharmacol. 1995 Oct 12;50(8):1273-9.
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD, USA.
� � � � � � � � � � � � � � � � �
2/1996 – Lipid metabolism as a target for brain cancer therapy:

Synergistic activity of lovastatin and sodium PHENYLACETATE against human glioma cells.
http://www.ncbi.nlm.nih.gov/m/pubmed/8592143/
Prasanna P, Thibault A, Liu L, et al: (SAMID D)
http://onlinelibrary.wiley.com/doi/10.1046/j.1471-4159.1996.66020710.x/abstract
J Neurochem 66:710-716, 1996
http://onlinelibrary.wiley.com/doi/10.1046/j.1471-4159.1996.66020710.x/abstract;jsessionid=913EBF64F1FA2FD0D08BD94FDDE391D5.d03t01
J Neurochem. 1996 Feb;66(2):710-6.
http://onlinelibrary.wiley.com/doi/10.1046/j.1471-4159.1996.66020710.x/abstract;jsessionid=E929EA030144CC973FECF4DAA1D9D50C.d01t04
Article first published online: 23 NOV 2002
DOI: 10.1046/j.1471-4159.1996.66020710.x
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland, USA.
� � � � � � � � � � � � � � � � �
5/1996PHENYLACETATE is an inhibitor of prostatic growth and development in culture.
http://www.ncbi.nlm.nih.gov/m/pubmed/8627880/
Lipshutz JH, SAMID D, Cunha GR:
J Urol 155:1762-1770, 1996
J Urol. 1996 May;155(5):1762-70.
The Journal of Urology
Volume 155, Issue 5, Pages 1762-1770, May 1996
Department of Medicine, University of California, San Francisco, USA.

References:

12. SAMID D, Yen A, Prasanna P . Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with PHENYLACETATE . Blood. 1992;80:1576
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
13. SAMID D, Shack S, Sherman LT . PHENYLACETATE: a novel nontoxic inducer of tumor cell differentiation . Cancer Res . 1992;52:1988
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
15. Ram Z, SAMID D, Walbridge S, Oshiro EM, Viola JJ, Tao-Cheng J, et al. Growth inhibition, tumor maturation, and extended survival in experimental brain tumors in rats treated with PHENYLACETATE . Cancer Res . 1994;54:2923
http://www.ncbi.nlm.nih.gov/m/pubmed/8187079/

http://m.cancerres.aacrjournals.org/content/54/11/2923.abstract

http://m.cancerres.aacrjournals.org/content/54/11/2923.full.pdf

http://cancerres.aacrjournals.org/content/54/11/2923
16. Liu L , Shack S , Stetler-Stevenson WG , Hudgins WR , SAMID D . Differentiation of cultured human melanoma cells induced by the aromatic fatty acids PHENYLACETATE and phenylbutyrate . J. Invest. Dermatol . 1994;103:335
http://www.ncbi.nlm.nih.gov/m/pubmed/8077698/
18. SAMID D , Shack S , Myers CE . Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of PHENYLACETATE . J. Clin. Invest . 1993;91:2288
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/

http://m.jci.org/articles/view/116457
19. Thibault A, Cooper MR, Figg WD, Venzon DJ, Sartor O, Tompkins AE, et al. (SAMID D) A phase 1 and pharmacokinetic study of intravenous PHENYLACETATE in patients with cancer . Cancer Res . 1994;54:1690
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/

http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract

http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf

http://cancerres.aacrjournals.org/content/54/7/1690
34. Sidell N, Wada R, Han G, Chang B, Shack S, Moore T, et al. al. (SAMID D). PHENYLACETATE synergizes with retinoic acid in inducing the differentiation of human neuroblastoma cells . Int. J. Cancer . 1995;60:507
http://www.ncbi.nlm.nih.gov/m/pubmed/7829265/
35. SAMID D, Ram Z, Hudgins WR, Shack S, Liu L, Walbridge S, et al. Selective activity of PHENYLACETATE against gliomas: resemblance to fetal brain damage in phenylketonuria . Cancer Res . 1994;54:891
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/
48. Fibach E, Prasanna P, Rodgers GP, SAMID D. Enhanced fetal hemoglobin production by PHENYLACETATE and 4-phenylbutyrate in erythroid precursor derived from normal donors and patients with sickle cell anemia and beta-thalassemia. Blood. 1993;82:2203
http://www.ncbi.nlm.nih.gov/m/pubmed/7691251/

http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.abstract

http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.full.pdf
49. George J , Dover GJ , Brusilow S , SAMID D . Increased fetal hemoglobin in patients receiving sodium 4-phenylbutyrate . N. Engl. J. Med . 1992;327:569
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
� � � � � � � � � � � � � � � � �
8/23/1996 – Activation of a human peroxisome proliferator-activated receptor by the antitumor agent PHENYLACETATE and its analogs.
http://www.ncbi.nlm.nih.gov/m/pubmed/8759039/
Pineau T, Hudgins WR, Liu L, et al: (SAMID D)
http://www.sciencedirect.com/science/article/pii/0006295296003401
Biochem Pharmacol 52:659-667, 1996
Biochem Pharmacol. 1996 Aug 23;52(4):659-67.
Laboratory of Molecular Carcinogenesis, National Cancer Institute, Bethesda, MD, USA.
� � � � � � � � � � � � � � � � �
9/1996 – The differentiating agent PHENYLACETATE increases prostate-specific antigen production by prostate cells.
http://www.ncbi.nlm.nih.gov/m/pubmed/8827086/
Walls R, Thibault A, Liu L, et al: (SAMID D)
Prostate 29:177-182, 1996
Prostate. 1996 Sep;29(3):177-82.
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland, USA.
� � � � � � � � � � � � � � � � �
12/1996 – Up-regulation and functional role of p21Waf1/Cip1 during growth arrest of human breast carcinoma MCF-7 cells by PHENYLACETATE.
http://www.ncbi.nlm.nih.gov/m/pubmed/8959328/
Gorospe M, Shack S, Guyton KZ, et al: (SAMID D)
http://cgd.aacrjournals.org/cgi/reprint/7/12/1609.pdf
Cell Growth Differ 7:1609-1615, 1996
Cell Growth Differ. 1996 Dec;7(12):1609-15.
Laboratory of Cellular and Molecular Biology, Gerontology Research Center, National Institute on Aging, NIH, Baltimore, Maryland, USA.
and Experimental Therapeutics Program, University of Virginia
Cancer Center, Charlottesville, Virginia

References:
1. SAMID, 0., Shack, S., and Myers, C. Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by nontoxic pharmacological concentrations of PHENYLACETATE. J. Clin. Invest., 91: 2288- 2295, 1993.
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/

http://m.jci.org/articles/view/116457
2. SAMID, D., Ram, Z., Hudgins, W. A., Shack, S., Liu, L, Walbridge, S., Oldfield, E. H., and Myers, C. E. Selective activity of PHENYLACETATE against malignant gliomas: resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1994.
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/

http://hwmaint.cancerres.aacrjournals.org/cgi/content/abstract/54/4/891
7. SAMID, D., Yeh, A., and Prasanna, P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with PHENYLACETATE. Blood, 80: 1576-1581, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract

http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
8. Shack, S., Miller, A., Liu, L., Prasanna, P., Thibault, A., and SAMID, D. Vulnerability of multidrug-resistant tumor cells to the aromatic fatty acids PHENYLACETATE and phenylbutyrate. Clin. Cancer Res., 2: 865-872, 1996.
http://www.ncbi.nlm.nih.gov/m/pubmed/9816242/

http://m.clincancerres.aacrjournals.org/content/2/5/865.abstract

http://m.clincancerres.aacrjournals.org/content/2/5/865.full.pdf
25. Shack, S., Chen, L-C., Miller, A. C., Danesi, A., and SAMID, D. Increased susceptibility of ras-transformed cells to PHENYLACETATE is associated with inhibition of p2i isoprenylation and phenotypic reversion. Int. J. Cancer, 63: 124-129, 1995.
http://www.ncbi.nlm.nih.gov/m/pubmed/7558439/
29. SAMID, D., Shack, S., and Sherman, L T. PHENYLACETATE. A novel nontoxic inducer of tumor cell differentiation. Cancer Res., 52: 1988- 1992, 1992.
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
30. Thibault, A., SAMID, D., Cooper, M. A., Figg, W. 0., Tompkins, A. C., Patronas, N., Headlea, 0. J., Kohler, 0. A., Venzon, 0. J., and Myers, C. E. Phase I study of PHENYLACETATE administered twice daily to patients with cancer. Cancer (Phila.), 75: 2932-2938, 1995.
http://www.ncbi.nlm.nih.gov/m/pubmed/7773944/

http://onlinelibrary.wiley.com/doi/10.1002/1097-0142(19950615)75:12%3C2932::AID-CNCR2820751221%3E3.0.CO;2-P/abstract
� � � � � � � � � � � � � � � � �
1997PHENYLACETATE and phenylbutyrate as novel, nontoxic differentiation inducers
http://www.ncbi.nlm.nih.gov/m/pubmed/9547596
D D SAMID, W R WR Hudgins, … C E CE Myers
http://link.springer.com/chapter/10.1007%2F978-1-4615-5325-0_67
Adv Exp Med Biol (1997), PMID.9547596
http://link.springer.com/content/pdf/10.1007%2F978-1-4615-5325-0_67.pdf
Adv Exp Med Biol. 1997;400A:501-5
DOI
10.1007/978-1-4615-5325-0_67
Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation, and Radiation Injury 2
Advances in Experimental Medicine and Biology Volume 400, 1997, pp 501-505
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD USA
� � � � � � � � � � � � � � � � �
8/1997 – Modulation of radiation response of human tumor cells by the differentiation inducers, PHENYLACETATE and phenylbutyrate.
http://www.ncbi.nlm.nih.gov/m/pubmed/9269314/
Miller AC, Whittaker T, Thibault A, et al: (SAMID D)
Int J Radiat Biol 72:211-218, 1997
Int J Radiat Biol. 1997 Aug;72(2):211-8.
Armed Forces Radiobiology, Research Institute, Bethesda, MD, USA.
� � � � � � � � � � � � � � � � �
3/1999Phase II study of PHENYLACETATE in patients with recurrent malignant glioma:
a North American Brain Tumor Consortium report
http://www.ncbi.nlm.nih.gov/m/pubmed/10071293/
S M Chang, J G Kuhn, … M D Prados
J Clin Oncol 17(3):984-90 (1999), PMID.10071293
J Clin Oncol. 1999 Mar;17(3):984-90
http://m.jco.ascopubs.org/content/17/3/984.long
References:

1. ↵ Hudgins WR, Shack S, Myers CE, et al: (SAMID D) Cytostatic activity of PHENYLACETATE and derivatives against tumor cells:

Correlation with lipophilicity and inhibition of protein prenylation. Biochem Pharmacol 50:1273-1279, 1995
http://www.ncbi.nlm.nih.gov/m/pubmed/7488244/

http://www.sciencedirect.com/science/article/pii/0006295295020133
2. SAMID D, Ram Z, Hudgins WR, et al: Selective activity of PHENYLACETATE against malignant gliomas:

Resemblance to fetal brain damage in phenylketonuria. Cancer Res 54:891-895, 1994
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/

http://m.cancerres.aacrjournals.org/content/54/4/891.abstract?ijkey=26b1701d60729aa2f907a74e3ae927f63a015c45&keytype2=tf_ipsecsha

http://cancerres.aacrjournals.org/content/54/4/891
3. Stockhammer G, Manley GT, Johnson R, et al: (SAMID D) Inhibition of proliferation and induction of differentiation in medulloblastoma and astrocytoma-derived cell lines with PHENYLACETATE. J Neurosurg 83:672-681, 1995
http://www.ncbi.nlm.nih.gov/m/pubmed/7674018/
4. ↵ Ram Z, SAMID D, Walbridge S, et al: Growth inhibition, tumor maturation, and extended survival in experimental brain tumors in rats treated with PHENYLACETATE. Cancer Res 54:2934-2927, 1994
http://www.ncbi.nlm.nih.gov/m/pubmed/8187079/

http://m.cancerres.aacrjournals.org/content/54/11/2934.abstract?ijkey=03bc67e581ef77536842806b949046916458d548&keytype2=tf_ipsecsha

http://m.cancerres.aacrjournals.org/content/54/11/2923.abstract

http://m.cancerres.aacrjournals.org/content/54/11/2923.full.pdf

http://cancerres.aacrjournals.org/content/54/11/2923
13. ↵ Gorospe M, Shack S, Guyton KZ, et al: (SAMID D) Up-regulation and functional role of p21Waf1/Cip1 during growth arrest of human breast carcinoma MCF-7 cells by PHENYLACETATE. Cell Growth Differ 7:1609-1615, 1996
http://www.ncbi.nlm.nih.gov/m/pubmed/8959328/

http://cgd.aacrjournals.org/cgi/reprint/7/12/1609.pdf
14. Walls R, Thibault A, Liu L, et al: (SAMID D) The differentiating agent PHENYLACETATE increases prostate-specific antigen production by prostate cells. Prostate 29:177-182, 1996
http://www.ncbi.nlm.nih.gov/m/pubmed/8827086/
15. Lipshutz JH, SAMID D, Cunha GR: PHENYLACETATE is an inhibitor of prostatic growth and development in culture. J Urol 155:1762-1770, 1996
http://www.ncbi.nlm.nih.gov/m/pubmed/8627880/
16. ↵ Sidell N, Wada R, Han G, et al: (SAMID D) PHENYLACETATE synergizes with retinoic acid in inducing the differentiation of human neuroblastoma cells. Int J Cancer 60:507-514, 1995
http://www.ncbi.nlm.nih.gov/m/pubmed/7829265/
17. ↵ Thibault A, SAMID D, Cooper MR, et al: Phase I study of PHENYLACETATE administered twice daily to patients with cancer. Cancer 75:2932-8, 1995
http://www.ncbi.nlm.nih.gov/m/pubmed/7773944/
18. ↵ Thibault A, Cooper MR, Figg WD, et al: (SAMID D) A phase I and pharmacokinetic study of intravenous PHENYLACETATE in patients with cancer. Cancer Res 54:1690-1694, 1994
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/

http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract

http://hwmaint.cancerres.aacrjournals.org/cgi/content/abstract/54/7/1690

http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf

http://m.cancerres.aacrjournals.org/content/54/7/1690

http://cancerres.aacrjournals.org/content/54/7/1690
20. ↵ Shack S, Chen L-C, Miller AC, et al: (SAMID D) Increased susceptibility of ras-transformed cells to PHENYLACETATE is associated with inhibition of p21ras isoprenylation and phenotypic reversion. Int J Cancer 63:124-129, 1995
http://www.ncbi.nlm.nih.gov/m/pubmed/7558439/

http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/abstract
21. ↵ SAMID D, Shack S, Sherman LT: PHENYLACETATE:

A novel nontoxic inducer of tumor cell differentiation. Cancer Res 52:1988-1992, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract?ijkey=b0c2c07340bcd5d9d1bb114912e8e4b98226c9fd&keytype2=tf_ipsecsha

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://cancerres.aacrjournals.org/content/52/7/1988

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf
22. ↵ Prasanna P, Thibault A, Liu L, et al: (SAMID D) Lipid metabolism as a target for brain cancer therapy:

Synergistic activity of lovastatin and sodium PHENYLACETATE against human glioma cells. J Neurochem 66:710-716, 1996
http://www.ncbi.nlm.nih.gov/m/pubmed/8592143/

http://onlinelibrary.wiley.com/doi/10.1046/j.1471-4159.1996.66020710.x/abstract

http://onlinelibrary.wiley.com/doi/10.1046/j.1471-4159.1996.66020710.x/abstract;jsessionid=913EBF64F1FA2FD0D08BD94FDDE391D5.d03t01
24. ↵ Pineau T, Hudgins WR, Liu L, et al: (SAMID D) Activation of a human peroxisome proliferator-activated receptor by the antitumor agent PHENYLACETATE and its analogs. Biochem Pharmacol 52:659-667, 1996
http://www.ncbi.nlm.nih.gov/m/pubmed/8759039/

http://www.sciencedirect.com/science/article/pii/0006295296003401
27. ↵ Miller AC, Whittaker T, Thibault A, et al: (SAMID D) Modulation of radiation response of human tumor cells by the differentiation inducers, PHENYLACETATE and phenylbutyrate. Int J Radiat Biol 72:211-218, 1997
http://www.ncbi.nlm.nih.gov/m/pubmed/9269314/
28. ↵ Piscitelli SC, Thibault A, Figg WD, et al: (SAMID D) Disposition of phenylbutyrate and its metabolites, PHENYLACETATE and phenylacetylglutamine. J Clin Pharmacol 35:368-373, 1995 Abstract
http://www.ncbi.nlm.nih.gov/m/pubmed/7650225/

http://m.jcp.sagepub.com/content/35/4/368.abstract?ijkey=74bff0d86ce76b404728762fe2a1bfde1641fa41&keytype2=tf_ipsecsha

http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1995.tb04075.x/abstract;jsessionid=DFDEF1599D764E2845EC2897269C198B.d01t01

http://jcp.sagepub.com/content/35/4/368

Burzynski, China, and Dvorit D. Samid

12/17/2012 – China
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524164
CDA-2 (cell differentiation agent 2), a URINARY preparation

CDA-2 and its main component PHENYLACETYLGLUTAMINE (PG or PAG)

Antineoplaston AS2-5 is PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplaston AS2-1 is a 4:1 mixture of phenylacetic acid (PA) and PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplastons AS2-5 and AS2-1 are derived from Antineoplaston A10

BURZYNSKI Reference: 22.
antineoplaston AS21

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0052117
National Cancer Institute, at the National Institutes of Health cancer . gov web-site re Antineoplastons:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5
PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplaston AS2-5 is PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplaston AS2-1 is a 4:1 mixture of phenylacetic acid (PA) and PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplastons AS2-5 and AS2-1 are derived from Antineoplaston A10

PHENYLACETYLGLUTAMINE (PAG or PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1

4/1994 – Dvorit D. SAMID et al.
A phase I … study of intravenous phenylacetate (PN) in patients with cancer

Cancer Res 54(7):1690-4 (1994), PMID 8137283

Cancer Res. 1994 Apr 1;54(7):1690-4

Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
Phenylacetate (PN) elimination was accounted for by conversion to PHENYLACETYLGLUTAMINATE (PG or PAG), which was excreted in the urine

4/1995 – Dvorit D. SAMID et al.
Disposition of Phenylbutyrate (PB) and its metabolites Phenylacetate (PN) and PHENYLACETYLGLUTAMINATE (PG or PAG)

J Clin Pharmacol 35(4):368-73 (1995), PMID 7650225

J Clin Pharmacol. 1995 Apr;35(4):368-73

Pharmacy Department, National Institutes of Health, Bethesda, Maryland, USA
http://www.ncbi.nlm.nih.gov/m/pubmed/7650225
PHENYLACETYLGLUTAMINATE (PG or PAG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of AS2-1