“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) 😊
——————————————————————
(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
——————————————————————
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
——————————————————————
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”
——————————————————————
(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)
——————————————————————
“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/
======================================
[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/
======================================
[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/
======================================
[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/
——————————————————————
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
——————————————————————
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
——————————————————————
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/
======================================
[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/
======================================
[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
——————————————————————
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:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/burzynski-timeline/
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Antineoplastons: Adverse Effects

National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons
Adverse Effects:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
� � � � � � � � � � � � � � � � �
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
�
1. 10/2003
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA
�
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003
�
12 patients
�
10 evaluable
�
1 – serious (grade 3) toxicity: reversible tinnitus
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
16. 2003
�
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
�
BT-11
�
BRAIN STEM GLIOMA
�
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:
�
a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
12 patients
�
10 evaluable
�
Pg. 96
�
Only mild and moderate toxicities were observed, which included:
3 – skin allergy
2 – anaemia
2 – fever
2 – hypernatraemia
1 – agranulocytosis
1 – hypoglycaemia
1 – myalgia
1 – numbness
1 – tiredness
1 – vomiting
� � � � � � � � � � � � � � � � �
Review Articles on Clinical Trials:
�
1. 3/2004
�
INTEGRATIVE CANCER THERAPIES
�
Burzynski, S.R.
�
The Present State of Antineoplaston Research
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964
�
Pg. 56
�
Adverse Reactions
�
Serious adverse reactions:
1.4% – anemia
0.5% – hypernatremia and fever
�
Moderate adverse reactions:
0.76% – skin rash
0.9% – slurred speech
�
Most patients experience increased diuresis, which may lead to dehydration and thirst
�
Adverse reactions observed have usually been transient and mild
�
Noted in our studies and due to phenylacetate, which is the main ingredient of AS2-1:
confusion
Reversible grade 1 somnolence
�
It’s suspected other adverse reactions observed in our studies were due to A10.
�
They weren’t observed by Buckner et al since they used approximately 50 times lower dosages of A10 in their study.
�
On the other hand, A10 induces diuresis, which may result in rapid elimination of AS2-1 through kidneys, which will lower concentration of AS2-1 in plasma and reduce chances for higher grade toxicity observed by Buckner et al. [49]
�
49. Burzynski SR. Efficacy of antineoplastons A10 and AS2-1.
http://www.ncbi.nlm.nih.gov/pubmed/10377942/
Mayo Clin Proc. 1999;74:641-642.
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942/
Mayo Clin Proc. 1999 Jun;74(6):641-2.
http://www.sciencedirect.com/science/article/pii/S0025619611641438
Mayo Clinic Proceedings
Volume 74, Issue 6 , Page 641, June 1999
�
Buckner et al described:
reversible grade 2 or 3 neurological toxicity, consisting of:
confusion
exacerbation of an underlying seizure disorder
transient somnolence
[48]
�
48. Buckner JD, Malkin MG, Reed E, et al. Phase II study of antineoplaston A10 (NSC 648539) and AS2-1 (NSC 620061) in patients with recurrent glioma. Mayo Clin Proc. 1999;74:137-145.
http://www.ncbi.nlm.nih.gov/pubmed/10069350/
Mayo Clin Proc. 1999 Feb;74(2):137-45.
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350/
Mayo Clinic Proceedings
Volume 74, Issue 2, February 1999, Pages 137–145
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Department of Oncology, Mayo Clinic Rochester, Minnesota, USA.
� � � � � � � � � � � � � � � � �
Case Reports:
�
4. 9/2004
�
INTEGRATIVE CANCER THERAPIES
�
Special exception (SE) to BT-11
�
BRAIN STEM GLIOMA
�
Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B.
�
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748
�
Pg. 257
�
40 – age
�
Mild reversible side effects
�
Pg. 258
�
9/30/2009 – admitted for administration of treatment
Mild hypernatremia – On several occasions discontinued treatment from 1 to 3 days
Increased fatigue – off treatment 2 days
3/29/2000 – White blood cell (WBC) count decreased and discontinued treatment for 3 days
�
Pg. 259
�
7/10/2000 – White blood cell (WBC) count decreased and discontinued treatment until treatment restarted 7/13/2000
7/15/2000 – discontinued treatment elevation of transaminases (serum glutamic oxaloacetic transaminase; serum glutamic pyruvic transaminase) until restarted 7/28/2000
8/2001 – developed persistent diarrhea and was referred to a gastroenterologist, but there were no pathological findings except for changes related to obesity
8/21/2001 treatment discontinued due to resolution of tumor
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
2. 10/2004
�
NEURO-ONCOLOGY
�
BT-20
�
Patients With GLIOBLASTOMA MULTIFORME (GBM)
�
Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004
�
22 evaluable patients
(6 men / 16 women / 27-63 /47 – median age)
�
Pg. 385
�
2 – grade toxicity: hypernatremia
2 – grade toxicity: somnolence
1 – grade 3 toxicity: anemia
1 – fatigue
1 – fever
1 – headache
1 – nausea
1 – tinnitus
1 – vomiting
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
3. 10/2004 (DBSG)
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004
�
60 patients
(31 treated under Special Exception)
�
1 – reversible grade 3 toxicity: anemia
1 – reversible grade 3 toxicity: hypertension
1 – reversible grade 3 toxicity: hypokalemia
1 – reversible grade 3 toxicity: neutropenia
1 – reversible grade 3 toxicity: allergic skin rash
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
4. 10/2004 (AT/RT of CNS)
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system
�
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004
�
11 children patients
(7 treated under Special Exception)
�
8 evaluable
�
1 – serious toxicity: reversible hypernatremia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
5. 10/2004
�
NEURO-ONCOLOGY
�
BT-12
�
CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
�
Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)
�
Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology
�
17 patients
(12 months – 23 / 6 – median age)
�
15 evaluable
�
1 – serious side effect: anemia
1 – serious side effect: fever
1 – serious side effect: granulocytopenia
� � � � � � � � � � � � � � � � �
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
Pg. 168
�
13 children patients – recurrent disease or high risk
�
10 males / 3 females
�
(1 – 11 – age / 5 years, 7 months – median age)
�
3 – younger than 3
�
Pgs. 168 and 170
�
8 – Medulloblastoma
3 – pineoblastoma
2 – other PRIMITIVE NEUROECTODERMALTUMORS (PNET)
�
Pg. 168
�
10-BT-12 (7 males / 3 females)
�
3 – CAN-01 (3 males)
�
Pgs. 168 and 173
�
serious side effects:
1 – anemia
1 – fever
1 – granulocytopenia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
7. 7/2005
�
Burzynski, S.R., Weaver, R.A., Janicki, T.J., Burzynski, B., Jurida, G. Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs. Neuro-Oncology. 2005; 7:300.
http://www.burzynskiclinic.com/images/stories/Publications/1224.pdf
Volume 7 Issue 3 July 2005
Abstracts from the World Federation of Neuro-Oncology Meeting
�
2 trials
�
Intrinsic diffuse brain stem glioma (BSG)
�
10 assessable patients
�
Less than 4 years old
(3 months – 3 years)
�
7 – no biopsy: dangerous tumor location
2 – anaplastic astrocytoma
1 – pilocytic astrocytoma
�
Serious toxicities:
Reversible anemia
Hypokalemia
�
No chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-03
�

�
BT-11
�
BRAIN STEM GLIOMA (BSG)
�
BT-18
�
6. MIXED GLIOMA
�
ADULT PATIENTS WITH MIXED GLIOMA
�
“mixed glioma”, a type of PMBT
�
CAN-01
�
CAN-1
�
PATIENTS WITH REFRACTORY MALIGNANCIES
�
19. 3/2006
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive BRAINSTEM GLIOMA. Integrative Cancer Therapies 2006;5(1):40-47
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
DOI: 10.1177/1534735405285380
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf
�
http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pg. 40
�
4 phase 2 trials
�
BRAINSTEM GLIOMA (BSG)
�
patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma
�
recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem
�
Pgs. 40 – 41 and 42
�
4 – glioblastomas (gliobastoma multiforme (GBM)) (GBM / BSG)
�
14 – anaplastic HBSG (patients with inoperable tumor of high-grade pathology (HBSG)) (Anaplastic astrocytoma / Anaplastic astrocytoma/mixed glioma)
�
14 – diffuse intrinsic tumors
�
12 – recurrence
�
18 patients
�
Pg. 42
�
(8 males / 10 females)
�
2 – 42 – age (10 – median age)
�
Pg. 43
�
BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female
�
Pg. 44
�
High-grade, recurrent, and progressive brainstem gliomas
�
Pgs. 40 and 45
�
Antineoplastons tolerated very well
1 – grade 4 toxicity (reversible anemia)
�
Pg. 45
�
2 – grade 3 toxicities: reversible anemia
�
Generally, the treatment was well tolerated and was free from chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
8. 10/2006
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1. Neuro-Oncology. 2006; 8:466.
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)
�
Brainstem gliomas and multicentric tumors (MBSG)
�
19 evaluable patients
�
3.9 – 40.8 (9.2 – median age)
�
(90% less than 18 years old)
�
95% diffuse intrinsic brain stem glioma
5% cervicomedullary tumor
�
The patients didn’t experience any serious toxicities (grades III – IV), and there were no chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
9. 4/2007 (NDBSG)
�
Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs. Neuro-Oncology 2007; 9:206.
http://www.burzynskiclinic.com/images/stories/Publications/4021.pdf
Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology
�
20 assessable children
�
3 months – 20 – age
�
5 – high-grade gliomas
�
Serious toxicities included:
5 – anemia
1 – elevation of transaminases
1 – hypokalemia
1 – skin rash
There were no chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
10. 6/2008 (OPG)
�
BT-23 – CHILDREN WITH VISUAL PATHWAY GLIOMA
�
Phase II study of antineoplastons A10 and AS2-1 (ANP) in CHILDREN WITH optic PATHWAY GLIOMA:
�
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7287.pdf
Neuro-Oncology 2008; 10:450
Volume 10 Issue 3 June 2008
�
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Samuel, Shiney
Szymkowski, Barbara G.
Walczak, Marek
Weaver, Robert A.
�
16.5 months (1 year 4.5 months) – Median antineoplaston treatment
�
6/2008 – Protocol – CHILDREN WITH optic PATHWAY GLIOMA
�
12 Evaluable Children Patients
(7 months – 16 years / 6 years 3 months – Median age)
——————————————————————
0 – lost to follow-up
——————————————————————
No grade 3 or 4 toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
11. 10/2008
�
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9)
�
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
17)
�
Phase II study of antineoplastons A10 and AS2-1 (ANP) in PATIENTS WITH newly diagnosed ANAPLASTIC ASTROCYTOMA:
�
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/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
�
Burzynski, Gregory
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Samuel, Shiney
Szymkowski, Barbara G.
Weaver, Robert A.
�
FDA monitored study
�
5.7 months – Median Duration of Treatment
�
10/2008 – Protocol – Patients with Newly Diagnosed ANAPLASTIC ASTROCYTOMA (AA)
�
20 Evaluable Patients
(22 – 64 years / 40 – Median age)
——————————————————————
2 / 10% – grade 3 toxicity possibly related to antineoplastons (ANP)
(Shortness of breath / generalized weakness)

Interim Reports on Clinical Trials:
�
12. 12/2008
�
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 9)
�
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 17)
�
Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in PATIENTS WITH recurrent ANAPLASTIC ASTROCYTOMA
http://www.burzynskiclinic.com/images/stories/Publications/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
�
Burzynski, Gregory
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Walczak, Marek
Weaver, Robert A.
�
6.5 months – Median duration of treatment
�
FDA-monitored phase II clinical trial
�
12/2008 – Protocol – ADULTS WITH recurrent ANAPLASTIC ASTROCYTOMA (AA)
�
20 – Evaluable Assessable Adult Patients
(20 – 51 years / 41 – Median age)
——————————————————————
1 / 5% – serious toxicity of hypernatremia
� � � � � � � � � � � � � � � � �
Case Reports:
�
BT-11 special exception (SE)
�
BRAIN STEM GLIOMA
�
1. 12/2009
�
Weaver, R.A., Szymkowski, B., Burzynski, S.R. Over a 10-year survival and complete response of a patient with diffuse intrinsic BRAINSTEM GLIOMA (DBSG) treated with antineoplastons (ANP). Neuro-Oncology 2009; 11:923.
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf
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
�
10.5 – age / female
�
1 episode of grade 3 vomiting which resolved within 3 days
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
13. 12/2009 (DBSG)
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11. Neuro-Oncology 2009, 11:951.
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf
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
�
40 patients
�
12 not evaluable
�
28 evaluable (ST) (23 children / 5 young adults)
�
12 – newly diagnosed / 16 previously treated)
�
Additional 52 evaluable (40 children / 12 young adults) treated under special exception (SE) (18 newly diagnosed)
�
ANP was well tolerated with serious toxicities occurring in less than 10% of patients in both groups:
anemia
dyspnea
elevated transaminases
fatigue
hypernatremia
hypokalemia
polyuria
skin rash
somnolence
subcutaneous extravasation
vomiting
�
No chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
14. 6/2010
�
BT-13 – CHILDREN WITH LOW GRADE ASTROCYTOMA
�
A Phase II Study of Antineoplaston A-10 and AS-1 Injections in CHILDREN WITH LOW-GRADE ASTROCYTOMAs.
http://www.burzynskiclinic.com/images/stories/Publications/8397.pdf
Neuro-Oncology 2010; 12, ii95.
Volume 12 Issue 6 June 2010
�
Acelar, Sheryll S.
Burzynski, Gregory S.
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Weaver, Robert A
�
17 / 100% – Evaluable for Safety
�
12 or more weeks or at least 4 weeks of Antineoplastons (ANP) but developed Progressive Disease (PD)
Patients Evaluable for Efficacy
�
83 weeks – Median Antineoplastons (ANP) (15 / 100% – Evaluable Patients)
�
6/2010 – Protocol – CHILDREN WITH Recurrent and / or Progressive LOW-GRADE ASTROCYTOMA (LGA)
�
17 Patients Accrued
(20 months {1 year 8 months} – 210 months {17 years 6 months} / 129 months {10 years 9 months} – Median age)
15 Evaluable Patients
�
Patients Showing Stable Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
Patients Showing Progressive Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
——————————————————————
Minimal toxicity
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
15. 11/2010
�
BT-18 – ADULT PATIENTS WITH MIXED GLIOMA
�
Preliminary Results of a Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in Adult Patients with Recurrent Mixed Gliomas.
http://www.burzynskiclinic.com/images/stories/Publications/8637.pdf
Neuro-Oncology 2010; 12:iv72.
Volume 12 Supplement 4 November 2010
�
Acelar, Sheryll S.
Burzynski, Gregory S.
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Weaver, Robert A
�
7 / 35% – not evaluated due to inadequate duration of treatment and lack of follow-up Magnetic Resonance Imaging (MRI) scans
�
4.4 months – median duration of treatment
�
11/2010 – Protocol – Adult Patients with Recurrent Mixed Gliomas
�
20 – Children Patients Accrued
13 – Evaluable Patients
(9 men / 4 women: 29 – 54 years / 38 – Median age)
——————————————————————
Antineoplastons (ANP) was well tolerated with the most common side effects being:
Dysgeusia
Hypernatremia
Hypersensitivity
Myalgias
Nausea
Urinary frequency
�
1 – Serious (grade 3) toxicity (urinary frequency)
�
No grade 4 toxicities

Phenylacetylglutamine (PG or PAG)

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

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

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