“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”
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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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Click to access 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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Critiquing: In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor…

“Orac” / Dr. David H. Gorski posted his lame 6/3/2013 excuse for a review of Burzynski: Cancer Is Serious Business, Part II (2), and I critiqued it:

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/
7/17/2013 Gorski pushed out his “best” effort:

In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor…
http://scienceblogs.com/insolence/2013/07/17/in-which-orac-does-stanislaw-burzynski-propagandist-eric-merola-a-favor/
After my Epic Sharknado Deconstruction of “Orac’s” “review,” I thought it only fair to continue the feeding frenzy with a Burzynski Texas Tornado

Believe it or not, I’m going to do “Dr.” Gorski (who particularly likes me, to the point of thinking, apparently, that I’m a white research supremacist) a favor

“Dr.” Gorski, as you recall, is a supposed “Doctor,” oncologist, breast cancer specialist, cancer (cough-cough) “researcher” who was responsible for two dubious propaganda reviews about documentary films which Eric Merola made re: Stanislaw Burzynski, the cancer doctor who has used “antineoplastons” to treat cancer without having published any final clinical trial evidence that they do what he claims, since his 1st completed phase II (2) clinical trial in 2009

However, no worries

M. D. Anderson did a clinical trial in 2006 and did NOT publish the final results until 6-7 years later, 2/13/2013

Based on that criteria, Burzynski has until 2016-2017 to publish

Back in 2010, Merola released the first of a dynamic duo of films, the first of which was called Burzynski The Movie: Cancer Is A Serious Business (as Gorski likes to call it, by adding an “A” in the title)

The sequel, the slightly less pretentiously titled Burzynski: Cancer Is A Serious Business, Part 2 (as Gorski again likes to call it with the “A”), was then released June 1 on various pay-per-view modes

As has been pointed out, it’s better than the first, and it features direct attacks on The Skeptics™, or SkeptiCowards©, if you will, who had the temerity to criticize Burzynski and Merola over the last couple of years with their school-yard bully attacks, NOT having the intestinal testicular fortitude to back up their claims with any citation(s), reference(s), and / or link(s) in support of their blatherskite, which they found worthy enough to defend on my blog

Merola is apparently trying to recreate the success of his previous strategy, which involved letting people watch the movie online for free for limited periods of time on websites like Mercola.com

I link directly to the Mercola.com link to the second Burzynski movie, because I want to give Mercola more Google juice than he already has

The movie was, however, on Vimeo until July 20:

BURZYNSKI: CANCER IS SERIOUS BUSINESS, PART II (2013) from BurzynskiMovie on Vimeo
http://articles.mercola.com/sites/articles/archive/2013/07/13/burzynski-cancer-film.aspx
If you want to see what the fuss was about and whether my criticisms of The Skeptics™, or SkeptiCowards©, were valid, now’s your chance

If you want to see the highlighted attack on The Skeptics™ SkeptiCowards©, it begins around 1:19 h into the movie

Yes, I’m encouraging you to watch Burzynski 2

It’s a beautiful example of all the things that Gorski tried to inculcate #TAM2013 attendees against

Indeed, dissecting this magnum opus is an excellent way to teach oneself critical thinking, much as dissecting creationist tripe is

Unfortunately, Gorski is unable to do this, because individuals like me, exist and will NOT let him get away with his disingenuous hack attacks

Other key points include:

Laura Hymas interview and the recording of her discussion with her oncologist (approximately 0:28 h in)

This section is horrifying (to Gorski, at least) to watch, as he can’t help but feel how dicey and ethical the situation that poor UK NHS oncologist found himself in with Hymas and her family demanding that he help her be part of one of Burzynski’s “clinical trials” by agreeing to be the local physician and agreeing to order various scans

The end of the story of Amelia Saunders (approximately 0:58 h in)

This is one where Merola caused Gorski true revulsion, as he basically implied that Amelia died because her parents took her off the antineoplastons

Or you can read what Eric Merola REALLY posted on Twitter:
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/fact-checking-httpthehoustoncancerquack-com/
Hideaki Tsuda’s clinical trial (approximately 1:31 h in)

Gorski wonders why he hasn’t yet published, just like he wonders why Burzynski hasn’t published, but Gorski, SkeptiCoward© that he is, can NOT seem to explain why The Lancet Oncology Peer Review Team D-12-01519 refused to publish Burzynski’s 11/26/2012 (1:29:53) phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results

Those of you who watch it, let Gorski know what you think

Those of you who can only watch part of it, let Gorski know what you think of that section

Remember, though, Gorski will BLOCK you if you question HIS infallibility, because he and his “Oracolytes” would rather comment on things that have NOTHING WHATSOEVER to do with Burzynski, like:

“it is possible to link without boosting google rankings through the “no-follow command”: http://en.wikipedia.org/wiki/Nofollow I learned about this from Bob Blaskiewicz, who proposed that we use this when linking to dubious websites in our posts”

Gorski makes unreliable excuses for NOT doing research re Burzynski, so I did it for him

Burzynski: Complete Response, Partial Response, Stable Disease, Progressive Disease, Objective Response, and Response:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-complete-response-partial-response-stable-disease-progressive-disease-objective-response-and-response/
Burzynski: Progression-Free Survival (PFS):
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-progression-free-survival/
Antineoplastons: Adverse Effects:
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/antineoplastons-adverse-effects/
Burzynski: Acknowledgements, Authors, and Co-Investigators:
https://stanislawrajmundburzynski.wordpress.com/2013/07/03/burzynski-acknowledgements/
Burzynski: Institutional Review Board (IRB):
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/burzynski-institutional-review-board-irb/
And because Gorski and others do NOT seem to understand how antineoplastons (ANP) A10 (Atengenal) and AS2-1 (Astugenal) work, I provide the relevant Burzynski publications and page #’s for them to review:
http://www.burzynskiclinic.com/scientific-publications.html
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Interim Reports on Clinial Trials
16. 2003 (BT-11)
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report.
DRUGS IN R&D
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs in R and D
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
(Drugs in Research and Development)

Click to access 960.pdf

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

Pg. 92
Antineoplaston A10 and AS2-1 are synthetic derivatives of phenylacetate (PN) acid, glutamine and isoglutamine

A10 is sterile solution of sodium phenylacetylisoglutiminate (isoPG) in 4 : 1 ratio

Antineoplaston AS2-1 is sterile solution of sodium phenylacetate (PN) and phenylacetylglutaminate (PG) in 4 : 1 ratio

Pg. 97
Discussion
Pg. 99

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Review Articles on Clinical Trials:
1. 3/2004
The Present State of Antineoplaston Research

Click to access 994.pdf

Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964
Volume 3 Number 1 March 2004

Pg. 47
Pg. 48
Mechanism of Action of Antineoplaston
Pg. 49
Pg. 50

The reason for 50% Progressive Disease (PD) in studies is long dose-escalation process, which extends to more than a month’s time period, before the optimal dosage is reached

Pg. 56
Conclusion

======================================
Case Reports:
4. 9/2004 (Special Exception (SE) to BT-11 Study (ST))
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme

Click to access 1145.pdf

Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748

Pgs. 257-258
Pg. 260
Discussion
Pg. 261

======================================
Interim Reports on Clinial Trials:
2. 10/2004
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent glioblastoma multiforme

Click to access 1218.pdf

Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004

Pg. 385
======================================
Interim Reports on Clinial Trials:
3. 10/2004 (Study (ST) and Special Exception (SE))
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma

Click to access 1219.pdf

Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004

Antineoplastons (ANP) consist of 3 active ingredients including sodium salts of phenylacetylglutamine (PG), phenylacetylisoglutimine (isoPG), and phenylacetic acid (PN)

Preclinical data supports that the mechanism of antineoplastic activity in DBSG, involves interruption of signal transmission in the RAS, (PN) AKT2, and TGFB1 (PG) pathways, activation of p53 and p21 tumor suppressor genes (PN) and apoptosis (PG and isoPG)

======================================
Interim Reports on Clinial Trials:
17. 2004 (BT-13 and BT-23)
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :
a preliminary report
DRUGS IN R&D
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs in R and D
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
(Drugs in Research and Development)

Click to access 1194.pdf

Drugs R D. 2004;5(6):315-26
Drugs R&D 2004;5(6):315-326.

Pg. 316
Pg. 324
Discussion

======================================
Interim Reports on Clinial Trials:
18. 6/2005 (CAN-01 and BT-12)
Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177

Click to access 1220.pdf

DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Volume 4 Number 2 June 2005

Pg. 168
Pg. 174
Discussion
Pgs. 175-176

======================================
Interim Reports on Clinial Trials:
19. 3/2006 (BT-03, BT-11, BT-18, and CAN-01)
Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive brainstem glioma.
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integrative Cancer Therapies 2006;5(1):40-47

Click to access 5825.pdf

DOI: 10.1177/1534735405285380
http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713

Pgs. 40-41
Pg. 46
Discussion
Conclusion

======================================
Interim Reports on Clinial Trials:
8. 10/2006
Treatment of multicentric brainstem gliomas with antineoplastons (ANP) A10 and AS2-1.

Click to access 2105.pdf

Neuro-Oncology. 2006; 8:466.
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)

Pg. 466
Antineoplastons (ANP) are synthetic analogues of naturally occurring phenylacetylglutamine (PG), phenylacetylisoglutimine (isoPG), and phenylacetate (PN)

======================================
Review Articles on Clinical Trials:
3. 12/2007
Recent clinical trials in diffuse intrinsic brainstem glioma. Cancer Therapy 2007; 5, 379-390.

Click to access 5692.pdf

Review Article
Cancer Therapy Vol 5, 379-390, 2007
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
Volume 5 Number 2 December, 2007

Pg. 381
Pg. 384
E. Multitargeted therapy

======================================
Interim Reports on Clinical Trials:
11. 10/2008
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
Phase II study of antineoplastons A10 and AS2-1 (ANP) in patients with newly diagnosed anaplastic astrocytoma:
A preliminary report

Click to access 7853.pdf

Volume 10 Issue 5 October 2008
Neuro-Oncology 2008; 10:821
Abstracts for the Thirteenth Annual Meeting of the Society for Neuro-Oncology, November 20-23, 2008

Pg. 821

Antineoplastons (ANP) are synthetic analogs of naturally occurring phenylacetylglutamine (PG), phenylacetylisoglutimine (isoPG), and phenylacetate (PN)

Antineoplastons (ANP) is a multi-targeted therapy affecting signal transduction, the cell cycle, the TCA cycle, and apoptosis

======================================
Interim Reports on Clinical Trials:
12. 12/2008
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA)
Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in patients with recurrent anaplastic astrocytoma

Click to access 7898.pdf

Neuro-Oncology 2008; 10:1067
Volume 10 Issue 6 December 2008
Abstracts for the Eighth Congress of the European Association for Neuro-Oncology (EANO), Sept. 12-14, 2008, Barcelona, Spain

Antineoplastons (ANP) affects multiple targets, and its components have different mechanisms of action

A10 interferes with signaling in the AKT2 and MYCC pathways, blocks expression of TGFB1, activates the PTEN and MAD tumor suppressor genes, and normalizes nuclear transport by decreasing the expression of RANBP1, which may restore the activity of the mutated INI protein

AS2-1 interferes with signal transmission in the RAS and BCL2 pathways and activates expression of the tumor suppressors TP53 and p21

======================================
Case Reports:
1. 12/2009 (BT-11 Special Exception (SE))
Over a 10-year survival and complete response of a patient with diffuse intrinsic brainstem glioma (DBSG) treated with antineoplastons (ANP).

Click to access 8638.pdf

Neuro-Oncology 2009; 11:923.
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO), May 11-14, 2009, Yokohama, Japan

Antineoplastons (ANP) is a multi-targeted therapy that is well tolerated with minimal and reversible adverse events and has multiple different mechanisms of action by affecting the AKT, RAS, TP53, p21, and PTEN pathways
======================================

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.

Click to access 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

Click to access 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.

Click to access 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