“The Amazing Meeting” (I don’t think it means, what you think it says it means): 2 Intellectually and Ethically Challenged Individuals, Twaddle at TAM 2013

Gentlemen, I start your Insolence 😇
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(1:30) [1]
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The “motto” of “The Amazing (Not so Much) Meeting” is “Fighting Fakers,” which is apropos, since I doubt that “Orac” the “Check my Facts” Hack of Dr. David H. Gorski, grasps the irony, that when I read some of his blog articles, you could easily switch his name with the name of some individual he is flogging, and the proverbial shoe fits, and:
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(1:40)
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“This is a guy who sometimes fools even, you know, physicians”
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(I couldn’t have said it better, myself) 😊
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(2:47)
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He states:

“There is a long segment about “The Skeptics”

(applause) 😝
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(4:25)
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“His lawyer wrote a book”

“About a half of it is about Burzynski [4]
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6:00
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Gorski mentions that Burzynski noticed that there were higher levels of these chemicals in healthy people, than people with cancer
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Whereas, Burzynski is on record as having said [5]:

” . . . healthy people have abundance of these chemicals in blood
Cancer patients have varied to none

I did NOT know before now, that GorskGeek thinks that “none” is a “level” 😶
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He continues:

AS2.1 – which is a chemical called phenylacetic acid, which is a byproduct of metabolism that turns into phenylacetylglutamine by the liver

A10 – soluble is basically the same thing
It breaks down to PAG
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WOW !

I thought it was: AS2 1 😊

They are “basically the same thing” ? 😳

What does Burzynski say ? [6]

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

PG and PN are naturally occurring in human body as result of metabolism of phenylalanine in liver and kidneys

formulation of antineoplaston AS2-1 is 4:1 mixture of synthetic PN and PG

A10 is 4:1 mixture of PG and iso-PG

That does NOT look like “basically the same thing” to me 😛

20131111-160455.jpg
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(6:50)
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Gorski founders on:

“And these are substances which were actually studied in the ’50’s and ’60’s and not found to be particularly, um, promising, but, he didn’t know that then”
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GorskGeek has #FAILED miserably to prove that on his blogs [7] 😄
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(8:00)
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Gorski comments about Burzynski’s “animal testing,” “species specific” claims:

“There are ways of getting around that”
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But Gorski, again, has #FAILED miserably to prove it [8] 😅
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(12:00)
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Gorski makes lame excuses about the NCI phase II clinical trial [9] 😖
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(12:50)
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Gorski claims Burzynski was indicted for insurance fraud in the 1997 case 😱
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GorskGeek, care to try and prove that one also ? [10] 😃
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(14:25)
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Gorski then states that out of 61 trials on clinicaltrials . gov, “most” are “closed or unknown”
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GorskGeek #FAILED again 😁

At the time it was:

1 – Not Yet Recruiting
(OPEN)(Phase 3)
1 – COMPLETED
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
10 – Recruiting
(10=OPEN)
40 – Active, not recruiting –
(40=CLOSED)
61 =TOTAL
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(15:20)
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Gorski attempts to go all “legal eagle”:

“Listen to Burzynski’s lawyer!”

“You listen to Burzynski’s lawyer; and, and I swear I don’t understand, like why Burzynski would let him, let his lawyer say stuff this damning in his own book, but he does”

“So, get a load of some of these quotes, referring to one of the clinical trials, he says:”

“It was a joke”

“. . . there could not be any possibility of meaningful data coming out of the so-called clinical trial, it was all an artifice, that, you know, designed so that they could continue giving the treatment

“The FDA wanted all of his patients to be on an IND, so, that’s what we did”
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Gorski, attorney Rick Jaffe is an American, living in America NOT the formerly communist Poland

He can say whatever he wants

GorskGeek is NOT a lawyer 😓

And there’s an excellent reason why

Nor is he schooled in the proper usage of the English language

FACT:

” . . . the so-called clinical trial . . .”

Any human being with a modicum of intelligence about the English language, understands that the term “clinical trial” is singular, i.e. one

Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]

One trial that is retrospective is CAN-1 Clinical Trial
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CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
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Clinical trial of patients treated by Dr. Burzynski through 2/23/1996

FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
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Gorski continues his trend of #FAILURES when he mentions the additional types of treatments that Burzynski was offering, but he #FAILED to mention [12] 😂
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” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials”
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(18:20)
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Gorski addresses the case of Tori Moreno
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Kim Moreno states:

“We originally were at Miller’s Children at Long Beach Memorial and then went to City of Hope

“We also sent her MRI’s to Dr. Fred Epstein in New York to be looked at”

Gorski suggests that 3 different opinions could have misdiagnosed Tori Moreno

You can read an interview with Tori’s mother [13]
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(19:45)
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Gorski goes on to mention Burzynski patients going to Texas Children’s Hospital with hypernatremia issues
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Gorski, do you mean this ? [14]

The changing pattern of hypernatremia in hospitalized children

Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
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(20:00)
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Gorski mangles the case of Hannah Bradley, who had a grade 3 anaplastic astrocytoma brain tumor

GorskGeek makes excuses like “spontaneous remission”, but then provides no citation, reference, or link to a case of such a tumor having spontaneously exhibited remission [15]
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(20:40)
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Gorski states that antineoplastons are chemotherapy
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No, Gorski, antineoplaston are:

“…an unapproved drug, not ordinary “chemotherapy [16] 😣
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(21:53)
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Gorski claims in regard to Burzynski’s personalized gene-targeted therapy:

” . . . gives to the patient without regard for synergistic toxicity

“Boom, there you go”
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Gorski’s #FAIL rate continues, as Burzynski has stated that phase 2 and 3 publications are reviewed as part of this process [17]

Gorski, “BOOM, THERE YOU GO” ッ
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Gorski, you should hire out to the Democratic Party as their mascot, because you must be the biggest pompous ASS I’ve ever seen 😜

Gorski, my advice: don’t quit your day job, HACK 😷
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The #TAM2013 audience then has to suffer through 22:36 of the blatherskite of Robert J. (don’t call me Bobby) “Bob” Blaskiewicz Blatherskitewicz [2]

He blathers about the “dozen,” “17,” “16 dead,” “pancreatic cancer,” “Joseph, who was alive but died well within the life expectancy given his diagnosis,” “Joann, who was alive but died within a year of starting therapy,” “Irene S., who was dead within month,” “Maxine, who was already dead,” the “103 in 2011,” “63 in mid-June,” “17 on original 1999 site,” “about 3 added a year,” the “about 50 stories,” “1/10th of patient names gathered,” “Amelia S. – 7, tumor breaking up,” “Chase,” “Cody – 1994, 20 years ago, 2 visits, 6 weeks treatment breaking up,” “David,” “Janet, 3 – 5 yrs., oncologist, now dead, ovarian cancer,” “Pete took video down,” “8,000 patients,” “probable ischemic necrosis,” “13 yr. old, getting worse getting better, vomited – Marlene, nurse,” “Rory died 2005,” “Supatra, swelling, last wed., brain tumor,” “Side-effect, 2%, sodium load,” “Andrea, U.S. News and World Report, 30% chance recovery, glioblastoma, ANP in luggage, died on plane,” “Cathy wanted to be on ANP, Greg Burzynski, found out only brain tumor,” “Denise D. breast cancer,” and finally:
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(18:45)
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” … and light as many fires under his butt as we can
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Mentions Rick Jaffe’s book Galileo’s Lawyer

IT’S ALL ABOUT THE PATIENTS [4]
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All you need to know about Blaskiewicz is:

“White man speak with forked tongue” [18]
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The 3rd video is a panel discussion, which includes “man-crush” tag-team [3]

Robert Blaskiewicz and David Gorski
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(8:00)
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Bob says:

“Yeah, I’m not that type of doctor
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Bob, the correct answer for you, is:

“I’m NOT a doctor” QUACK
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(13:05)
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Gorski gabs that he’s a:

“Game of Thrones Geek”
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I just knew I was right, GorskGeek [19]
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(14:00)
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The only female panelist mentions “bureaucrats”, “wimps”, and “people without balls”
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2 out of 3 ain’t bad

She describes the Bob and David show to a T
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(15:00)
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The claim is made that a Burzynski physician appeared on the Burzynski Facebook page announcing results
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(16:00)
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Gorski #whines that the Texas Medical Board wasn’t successful in shutting Burzynski down because of “politics”
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LAUGHABLE
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(20:55)
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Gorski gives his usual excuse:

“He’s not an oncologist”
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GorskiGeek, that claim is as dead as apparently, quite a number of your brain cells [15]
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(34:40)
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Audience members are given the opportunity to speak, and this is the garbage served up:
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“Hi, this is Susan

Ah, don’t forget to mention that Wikipedia has been a major battlefield

We’ve had 23,000 views to the clinic’s page this last month, also rebutr . . .”
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“Control the flow of information”
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Gorski pipes up:

“What she said”
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(35:20)
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Blatherskitewicz chimes in:

“When it comes to Wikipedia can I just mention that is, that is, that that is so effective that Wikipedia was singled out in the most recent Burzynski movie
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Gorski chirps:

“Yes”
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Bob yacks:

“as being controlled by evil skeptics
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Gorski ejaculates:

“No, seriously”
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Bob bleats:

“No”

(applause)
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“You have to unleash the evil hoards of skeptics

“Wahahaha” 👿
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Dr. Stanislaw Burzynski on Wikipedia:

“Simply don’t pay attention to it, because it, it’s not true”

“You won’t be able to, do any, clinical research which we do, without convincing evidence, especially when you have the most powerful agency in the government which is against you

“So they would love to find something which is wrong with what we are doing”

“Ah, so the fact that they’ve, um, agreed that what we have has value, and they allow us to do phase 3 clinical trials it means that we are right”

“Because, uh, uh, nobody who didn’t have any, concrete evidence that it works, would be able to go as far”

“So whatever Wikipedia says, well, I don’t care for them

(laughing) [5]
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Enlightening ?

Inspiring ?

Amazing ?

Hypocrites

Apparatchiks [20]
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REFERENCES:
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[1]David Gorski – Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine – TAM 2013 11/8/2013 (22:44)
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[2]Robert Blaskiewicz – Why We Fight (Part II): It’s All About The Patients – TAM 2013 11/8/2013 (22:36)
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[3] – Medical Cranks And Quacks
TAM 2013 JREF
11/8/2013 (42:42)
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[4]“Galileo’s Lawyer” Richard A. Jaffe, Esq.
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http://www.richardjaffe.com
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[5] – 11/9/2013 – Pete Cohen chats with Dr. Stanislaw Burzynski:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski/
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[6] – 6/2012 – Journal of Cancer Therapy, 2012, 3, 192-200 doi:10.4236/jct.2012.33028 Published Online June 2012, Pg. 192
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http://www.burzynskiclinic.com/images/stories/Publications/9219.pdf
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[7]Burzynski: Oh, RATS!!!:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/26/the-lancet-oncology-peer-review-team-d-12-01519-fail-2/
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[8] – Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-how-stanislaw-burzynski-became-burzynski-the-brave-maverick-doctor-part-1/
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[9] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
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[10] – 9/25/2013 – Critiquing: National Council Against Health Fraud, Inc. – NCAHF News: JURY NULLIFICATION THWARTS BURZYNSKI CONVICTION:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/25/critiquing-national-council-against-health-fraud-inc-ncahf-news-jury-nullification-thwarts-burzynski-conviction/
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[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
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[12] – 4/26/2013 – Burzynski: FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston CLINICAL TRIALS:
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https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-fda-requirements-that-cancer-patients-utilize-more-traditional-cancer-treatment-options-in-order-to-be-eligible-to-participate-in-the-companys-antineoplaston-clinical-trials/
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[13] – Tori Moreno
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http://www.cancerinform.org/aburzinterview2.html
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[14] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
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http://www.ncbi.nlm.nih.gov/m/pubmed/10469766/
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[15] – 11/2/2013 – Critiquing: Dr. Stanislaw Burzynski’s cancer “success” stories:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/02/critiquing-dr-stanislaw-burzynskis-cancer-success-stories/
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10/25/2013 – Hannah Bradley – I Feel Empowered, In Control Of My Body: Four Women On Fighting Cancer With Alternative Therapies http://www.telegraph.co.uk/health/10383724/I-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies.html
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https://stanislawrajmundburzynski.wordpress.com/2013/10/25/hannah-bradley-i-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies-httpwww-telegraph-co-ukhealth10383724i-feel-empowered-in-control-of-my-body-fo/
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[16] – NOT ORDINARY CHEMOTHERAPY
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https://bulk.resource.org/courts.gov/c/F3/27/27.F3d.153.93-2071.html
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[17] – 9/4/2013 – University of Michigan, where is alum Dr. David H. “Orac” Gorski’s Grapefruits ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/04/university-of-michigan-where-is-alum-dr-david-h-orac-gorskis-grapefruits/
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[18] – 10/13/2013 – Why “The Skeptics™” Perfessor Robert J. (don’t call me “Bobby”) “Bob” Blaskiewicz (@rjblaskiewicz) of University of Wisconsin, Eau Claire, “Fame,” is a Coward and a Liar:
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https://stanislawrajmundburzynski.wordpress.com/2013/10/13/why-the-skeptics-perfessor-robert-j-dont-call-me-bobby-bob-blaskiewicz-rjblaskiewicz-of-university-of-wisconsin-eau-claire-fame-is-a-coward-and-a-liar/
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[19] – 10/27/2013 – “The Skeptics™” Burzynski Bias, Censorship, Lies, and Alibi’s: September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
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https://stanislawrajmundburzynski.wordpress.com/2013/10/27/the-skeptics-lie-lied-lies-liars-lying-burzynski-bias-censorship-lies-and-alibis-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewic/
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[20] – 11/9/2013 – Wikipedia Articles:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/11/burzynski-timeline/
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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
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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
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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
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� � � � � � � � � � � � � � � � �
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
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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.

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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

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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.
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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/

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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
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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.

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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

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

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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
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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
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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

Antineoplastons: Phenylacetylglutaminate (PG or PAG), Phenylacetate (PN), and Phenylbutyrate (PB)

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)
� � � � � � � � � � � � � � � �
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
� � � � � � � � � � � � � � � �
http://www.burzynskiclinic.com/scientific-publications.html
Review Articles on Clinical Trials:
�
1. 3/2004
�
Burzynski, S.R. The Present State of Antineoplaston Research. Integrative Cancer Therapies 2004;3:47-58.
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Volume 3 Number 1 March 2004
DOI: 10.1177/1534735403261964
�
Pg. 48
�
Antineoplaston A2, which contributed to the highest number of complete responses in phase I clinical studies, was elected for final purification, isolation of active components, and structure determination.
Active ingredient identified as:
3-phenylacetylamino-2, 6-piperidinedione
and was named
antineoplaston A10. [27]
�
27. Burzynski SR, Hendry LB, Mohabbat MO, et al. Purification of structure determination, synthesis and animal toxicity studies of antineoplaston A10. In: Proceedings of the 13th International Congress of Chemotherapy. Vienna, Austria; 1983:17, PS. 12.4 11-4.
�
A10 has been reproduced by synthesis involving condensation of:
1-glutamine
with
phenylacetyl chloride
and subsequent cyclization of
phenylacetylglutamine (PG). [28]
�
28. Burzynski SR, Hai TT. Antineoplaston A10. Drugs of the Future. 1985;10:103-105.
�
Metabolism of A10 in human body yields:
phenylacetylglutamine (PG)
phenylacetylisoglutamine (isoPG)
phenylacetate (PN)
which were reproduced synthetically and formulated into:
antineoplaston
A10 injections (A10-I)
AS2-1
AS5
AS-25
[29-33]
�
29. Burzynski SR. Synthetic antineoplastons and analogs. Drugs of the Future. 1986;11:679-688.

30. Burzynski SR, Mohabbat MO, Lee SS. Preclinical studies of antineoplaston AS1-1 and antineoplaston AS2-5. Drugs Exptl Clin Res. 1986;12(suppl 1):11-16.
http://www.ncbi.nlm.nih.gov/pubmed/3743376/

http://www.ncbi.nlm.nih.gov/m/pubmed/3743376/
31. Burzynski SR, Khalid M. Antineoplaston A10 injections. Drugs of the Future. 1986;11:364-365.

32. Burzynski SR, Khalid M. Antineoplaston AS2-1. Drugs of the Future. 1986;11:361-363.

33. Burzynski SR. Antineoplaston AS2-5.. Annual Drug Data Report. 1986;8-319.
�
These formulations were submitted for basic research and phase I clinical studies. [34-44]
�
34. Burzynski SR, Mohabbat MO, Burzynski B. Animal toxicology studies on oral formulation of antineoplaston A10. Drug Exptl Clin Res. 1984;10:113-118.

35. Burzynski SR. Phase I clinical studies of antineoplaston AS2-5 injections. In: Ishigami J, ed. Recent Advances in Chemotherapy. Tokyo, Japan: University of Tokyo Press; 1985.

36. Burzynski SR, Burzynski B, Mohabbat MO. Toxicology studies of antineoplaston AS 2-1 injections in cancer patients. Drugs Exptl Clin Res. 1986;12(suppl 1):25-35.
http://www.ncbi.nlm.nih.gov/pubmed/3743378/

http://www.ncbi.nlm.nih.gov/m/pubmed/3743378/
37. Burzynski SR, Kubove E. Toxicology studies of antineoplaston A10 injections in cancer patients. Drugs Exptl Clin Res. 1986;12(suppl 1):47-55.
http://www.ncbi.nlm.nih.gov/pubmed/3743380/

http://www.ncbi.nlm.nih.gov/m/pubmed/3743380/
38. Lehner AF, Burzynski SR, Hendry LB. 3-phenylacetylamino-2,6-piperidinedione, a naturally-occurring peptide analog with apparent antineoplastic activity may bind to DNA. Drugs Exptl Clin Res. 1986;12(suppl 1):57-72.
http://www.ncbi.nlm.nih.gov/pubmed/3743381/

http://www.ncbi.nlm.nih.gov/m/pubmed/3743381/
39. Ashraf AQ, Liau MC, Mohabbat MO, et al. Preclinical studies of antineoplaston A10 injections. Drugs Exptl Clin Res. 1986;12(suppl 1):37-45.
http://www.ncbi.nlm.nih.gov/pubmed/3743379/

http://www.ncbi.nlm.nih.gov/m/pubmed/3743379/
40. Ashraf AQ, Liau MC, Kampalath BN, et al. Pharmacokinetic study of radioactive antineoplaston A10 following oral administration in rats. Drugs Exptl Clin Res. 1987;13(suppl 1):45-50.
http://www.ncbi.nlm.nih.gov/pubmed/3569015/

http://www.ncbi.nlm.nih.gov/m/pubmed/3569015/
41. Hendry LB, Muldoon TG, Burzynski SR et al. Stereochemical modeling studies of the interaction of Antineoplaston A10 with DNA. Drugs Exptl Clin Res. 1987;13(suppl 1):77-81.
http://www.ncbi.nlm.nih.gov/pubmed/3569020/

http://www.ncbi.nlm.nih.gov/m/pubmed/3569020/
42. Ashraf AQ, Burzynski SR. Comparative study of antineoplaston A10 levels in plasma of healthy people and cancer patients. Adv Exptl Clin Chemother. 1988;2:19-28.

43. Ashraf AQ, Kampalath BN, Burzynski SR. Pharmacokinetic analysis of antineoplaston A10 injections following intravenous administration in rats. Adv Exptl Clin Chemother. 1988;6:33-39.

44. Burzynski SR, Kubove E, Burzynski B. Phase I clinical studies of oral formulation of antineoplaston AS2-1. Adv Exptl Clin Chemother. 1988;2:29-36.
�
A10
A10-I
AS2-1
were selected for phase II studies.
2 initial phase II studies in
ASTROCYTOMA
and
HIGH-GRADE GLIOMA
began in
1988
and
1990
and were conducted outside investigational new drug (IND) process.
�
Since 1994 the FDA authorized 74 phase II studies with
A10
A10-I
AS2-1
under INDs
43,742
22,029
in advanced malignancies.
�
Pg. 49
�
Phenylacetate (PN)
is active ingredient of
antineoplaston AS2-1.
�
Phenylglutamine (PG)
is main ingredient of
A10-I.
�
Phenylglutamine (PG) exhibits antineoplastic activity across wide array of cancer cell lines.
�
Phenylglutamine (PG)
inhibits uptake of growth-critical amino acids, such as:
1-glutamine
and
1-leucine
in neoplastic cells.
�
Reduction in amino acid availability may contribute to drug’s antineoplastic activity.
�
Human glioma (U-87) cells rapidly take up Phenylglutamine (PG) by mechanism similar to facilitated diffusion.
�
Upon removal of Phenylglutamine (PG) from media, PG rapidly and completely effluxes from the cell.
�
Phenylglutamine (PG)
enters cells via stereospecific amino acid transporters for
1-glutamine.
�
Formulations of
Antineoplastons:
�
Antineoplastons
are a class of 12 antitumor agents.
�
Following synthetic antineoplaston formulations used in phase II studies.
�
Antineoplaston A10
capsules contain 500 mg of
3-phenylacetylamino-2, 6-piperidinedione.
�
Antineoplaston A10 injection
is mixture of sodium salts of
Phenylglutamine (PG)
and
Phenylacetylisoglutamine (isoPG)
in 4:1 ratio.
�
Available in 500 mL and 1000 mL (300 mg/mL) plastic bags.
�
Antineoplaston AS2-1
capsules containing 500 mg of 4:1
Phenylacetate (PN)
and
Phenylglutamine (PG).
�
Antineoplaston AS2-1 injection
is mixture of
Phenylacetate (PN)
and
Phenylglutamine (PG)
in 4:1 ratio.
�
Available in 250 mL (80 mg/mL) plastic bags.
� � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
18. 6/2005
�
INTEGRATIVE CANCER THERAPIES
�
BT-12
�
CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
�
CAN-01
�
CAN-1
�
PATIENTS WITH REFRACTORY MALIGNANCIES
�
Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMALTUMORS treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Antineoplastons (ANP) A10 and AS2-1, which are synthetic analogs of naturally occurring derivatives of glutamine, isoglutamine, and phenylacetic acid, have shown an increasing spectrum of activity in primary brain tumors. [1]
�
Review Articles on Clinical Trials:
�
1. 3/2004
�
Burzynski, S.R. The Present State of Antineoplaston Research. Integrative Cancer Therapies 2004;3:47-58.
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Volume 3 Number 1 March 2004
DOI: 10.1177/1534735403261964
� � � � � � � � � � � � � � � �
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
� � � � � � � � � � � � � � � �
Sodium Phenylbutyrate (PB)
Year – Pubmed (110 entries)
1958 1st entry
1995 1st clinical trial
2001 Phase 1
2009 Phase 2
2012 Phase 3
� � � � � � � � � � � � � � � �
Phenylacetate (PN)
Year – Pubmed (29,686 entries)
1883 1st entry
1994 Phase 1
1999 Phase 2
2013 latest
� � � � � � � � � � � � � � � �
Antineoplaston(s)
Year – Pubmed (88 entries)
1976 1st entry
1986 Phase 1
1999 Phase 2
2003 Phase 2 preliminary
2004 Phase 2 preliminary
2012 latest
� � � � � � � � � � � � � � � �
National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons (PDQ®) Overview:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page1

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
History:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page3
Laboratory/Animal/Preclinical Studies:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page4
Human/Clinical Studies:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5
Adverse Effects:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
Summary of the Evidence for Antineoplastons:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page7
Changes to This Summary:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page8
About This PDQ Summary:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page9
Questions and Answers About Antineoplastons:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2
Current Clinical Trials:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page3
Changes to This Summary:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page4