Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

[1] – 9/19/2013 – “Americans love to fight, traditionally”

“All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players”

“Americans love a winner”

“Americans will not tolerate a loser”

– General George S. Patton, Jr., June.5, 1944

The above might as well be Greek to Dr. David H. Gorski a/k/a “Orac”

He’s the epitome of the word “loser”

Indeed, “Orac” described his work-place nemesis as “user hostile”

After 5 years, he still didn’t fully understand much of it, and he claims he’s not exactly computer illiterate

Gorski is that “guy” who couldn’t even find Burzynski’s publication:

[2] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer

[3] – “Orac” batted the big “O” when he tried to find “the scientific rationale to expect that” antineoplastons “might have antitumor activity”

[4] – Gorski was geniusless when it came to finding “which genes are targeted by antineoplastons,“ proving that he really does NOT know Burzynski’s personalized gene-targeted therapy

In fairness, I will point out that he hasn’t put the time in to learn all the ins and outs of the system …

He pontidefecates about phase II clinical trials when his name isn’t even on a phase 2 trial, too

[5] – 9/19/2013 – He’s the “guy” who’s “mystified” as to how Stanislaw Burzynski “has managed to keep practicing for 36 years after he first began treating patients with an unapproved (not ordinary) chemotherapeutic drug (the concoction of peptides purportedly isolated from blood and urine that Burzynski dubbed “antineoplastons” because of their alleged ability to inhibit the growth of cancer)”

This is not an issue unique to Gorski; I’ve discussed other cases like this, such as Bobby Blaskiewicz, who used his man-crush relationship with Gorski to appear on the Skeptic Canary Show; Davey James, who was only recently stripped of his license to practice in several states of mind; Adam Jacobs, who went so far as to use his business influence to alter his Dianthus Mediclueless web-site in London to be more hack friendly, and an interventist who administered twerkpidity to posers who didn’t have common sense and defrauded minions for tens of millions of minutia

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake

[6] – He has NOT yet figured out that Burzynski learned from the best

[7] – Who could do it better than someone like Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) who Burzynski had to deal with:

“This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded

“However, your letter conspicuously fails to address them

“You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false”

Pg. 2

“I am glad that you plan to “thoroughly examine the accusations” I have made”

“I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995”

20130920-220216.jpg

20130920-220507.jpg
After all, can we really take a person seriously, who claimed:
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[8] – 11/2/2012 – “Personally, having pored over Burzynski’s publications … “
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[9] – 5/8/2013 – “I’ve searched Burzynski’s publications … “
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[10] – 6/5/2013 – “ … I do know cancer science”
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Uhhhhhhh … yeah

But do you really know Burzynski’s cancer science when you did NOT even know:

“which genes are targeted by antineoplastons“?

Has “GOraCON” (“Orac” + @Gorskon) even read these ?
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[11] – 10/2003 – Waldbillig R, Burzynski SR. Mechanism of action, uptake, and gene array studies on the antineoplastic agent phenylacetylglutamine (PG) in human glioma cells U-87. Neuro-Oncology. 2003; 5: 309

Volume 5 Issue 4 October 2003

(genes CD38, OASL, and TCF8)
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[12] – 10/2007 – Patil, S., Burzynski, S.R., Mrowczynski, E., Grela, K. Phenylacetylglutamine (PG) and phenylacetate (PN) interact additively to produce detachment-induced apoptosis/anoikis in glioblastoma cells. Neuro-Oncology 2007; 9:482

Volume 9 Issue 4 October 2007

We have conducted a total human gene array screen using the Affymetrix Human Genome plus 2.0 oligonucleotide arrays, for genes regulated by PG and a combination of PG and PN

gene TXNIP was up-regulated almost 5-fold with PG, and almost 120-fold using a combination of PG and PN

genes that are significantly up-regulated are CLDND1, ATF3, CASP5, TP53, TRIB3, and UNC5B

Genes that were down-regulated include AKT2, ASPM, CDCA8

(caspase 5, p53, netrin receptor) and AKT pathway (AKT2, TRB3)
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[13] – 10/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. Antineoplaston AS2-1 affects cell cycle checkpoints, leading to apoptosis in human glioblastoma cells. Neuro-Oncology 2008; 10:786

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

CDCs 25A and 25B, cyclins D3 and E, and CDKs 3, 4, and 6

ORC1L and CDC6

MCMs 2, 3, 4, 5, 6, and 7, and CDC7

cyclins A, B1, and B2, polykinase 1, and CDKs 1 and 2

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

Based on pathway analysis, it was observed that anti-neoplastons affected the expression of more than 40 genes instrumental in the cell cycle in GBM cells
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[14] – 12/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008; 10:1148

Volume 10 Issue 6 December 2008

In 2004 the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma

12 FDA-supervised phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumors

A total human gene array screen using the Affymetrix Human Genome

The expression of mRNA for vitamin D3 up-regulated protein 1 (VDUP1) was found to be over 100 fold higher for cells treated with PG and PN

succinate dehydrogenase C (SDHC), fumarate hydrogenase (FH), succinate-CoA ligase 1 and 2 (SUCLG1and 2), and aconitase 2 (ACO2)
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[15] – 11/2010 – Patil S, Burzynski SR, Mrowczynski E, Grela K. Targeting MicroRNAs in Glioma Cells with Antineoplastons. Neuro-Oncology 2010; 12, iv10

Volume 12 Supplement 4 November 2010

This study was done using the Dharmacon mRNA profiling array (Thermo Fisher Scientific)

mRNAs 125a-5p and 125a-3p

mRNAs 125a-5p has recently been shown to be regulated by the epidermal growth factor receptor and to function as a tumor suppressor in lung cancer

It has also been shown that the over-expression of mRNA 125a or mRNA 125b caused reduced migration and invasion of SKBR3 breast cancer cells

Using the total human microarray screen (Affymetrix)

AKT2
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[16] – 6/2012 – Sonali, S. Patil, Stanislaw R. Burzynski, Emilia Mrowczynski, Krzysztof Grela, Sridar V. Chittur. Phenylacetylglutaminate and Phenylacetate in combination Upregulate VDUP1, cause cell cycle blockade and Apoptosis in U87 Glioblastoma cells. Journal of Cancer Therapy 2012;3:192-200
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[17] – 9/2012 – Patil, S., Burzynski S.R., Mrowczynski, E., Grela, K. P.003. Phenylacetylglutaminate in combination with Phenylbutyrate effectively inhibits growth of brain tumor cell In Vitro. Neuro-Oncology 2012;14(Suppl. 3):iii16

Volume 14 Supplement 3 September 2012

The FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of gliomas, in 2009

12 FDA-supervised Phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumor

AKT2

PG is not toxic to normal cells whereas PB has dose-limiting neuro-cortical toxicity
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Cancer care: Is the system “in crisis” ?

The Institute of Medicine, just in case you’re like “Orac” and have NOT yet figured it out, “the system” has been “in crisis” since the Gubment “forgot” who they are here to serve

[18] – Gorsi, maybe you can explain to The Institute of Medicine why the Cancer care system is “in crisis” because M.D.’s with Ph.D’s who hold positions “at an NCI-designated comprehensive cancer center,”are responsible for massive fact-checking #FAILS

What did you do, Gorski ?

Phone It in again ?
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REFERENCES:
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[1] – 9/19/2013 – The Institute of Medicine report on cancer care: Is the system “in crisis” ?
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http://scienceblogs.com/insolence/2013/09/19/the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
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[2] – 1997 – Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/26/x/
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[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™
http://www.scienceblogs.com/Insolence
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https://stanislawrajmundburzynski.wordpress.com/2013/08/08/critiquing-dr-david-h-orac-gorski-and-the-skeptics/
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[4] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
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https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
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[5] – 9/19/2013 – Another case of the failure of physician regulation endangering patients
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http://scienceblogs.com/insolence/2013/09/19/another-case-of-the-failure-of-physician-regulation-endangering-patients/
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[6] – Critiquing: Dr. Michael A. Friedman, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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DID Dr. Michael A. Friedman FIB?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/18/did-dr-michael-a-friedman-fib/
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Dr. Michael A. Friedman, DATA ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/dr-michael-a-friedman-data/
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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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[8] – 11/.2/2012
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http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
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[9] – 5/8/2013
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http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
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[10] – 6/5/2013
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http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
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[11] – 10/2003
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http://www.burzynskiclinic.com/images/stories/Publications/971.pdf
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[12] – 10/2007
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http://www.burzynskiclinic.com/images/stories/Publications/5169.pdf
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[13] – 2008
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http://www.burzynskiclinic.com/images/stories/Publications/7854.pdf
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[14] – 2008
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http://www.burzynskiclinic.com/images/stories/Publications/7897.pdf
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[15] – 11/2010
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http://www.burzynskiclinic.com/images/stories/Publications/8636.pdf
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[16] – 6/2012
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/9219.pdf
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Journal of Cancer Therapy, 2012, 3, 192-200
doi:10.4236/jct.2012.33028 Published Online June 2012
5. Acknowledgements
This study was supported by and carried out at the Burzynski research Institute (BRI), Houston TX, USA. The Microarray assay was supported by BRI and carried out at Center for Functional Genomics, University of Albany, NY, USA
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[17] – 9/2012
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http://www.burzynskiclinic.com/images/stories/Publications/9291.pdf
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http://www.burzynskiclinic.com/scientific-publications.html
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[18] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
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https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
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Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

12/5/2012 Dr. David H. “Orac” Gorski, who claims to be a “researcher,” cooked up this gastronomically inedible MUD pie:

Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
http://scienceblogs.com/insolence/2012/12/05/arrogance-of-ignorance-about-cancer/
and 3/11/2013 on #ScienceBasedMedicine . org:

Three myths about Stanislaw Burzynski and The Skeptics
——————————————————————
5-6/2012 – Stanislaw R. Burzynski, MD, PhD: novel cancer research and the fight to prove its worth
http://www.ncbi.nlm.nih.gov/pubmed/22875562/
Altern Ther Health Med. 2012 May-Jun;18(3):54-61.
http://www.ncbi.nlm.nih.gov/m/pubmed/22875562/
——————————————————————
Here we go again

Now here’s where we see the sheer arrogance, the sheer ignorance of the man:

Gorski quotes Dr Burzynski:

“I published the review article in a peer-reviewed journal almost 20 years ago on the principles of personalized gene-targeted therapy”

Gorski states:

“Curious as to just what the heck Burzynski was talking about here, I searched PubMed for this alleged review article”

“I couldn’t find it on PubMed”

“His only publications from the 1990s had nothing to do with cancer as a “genetic disease” or “personalized gene-targeted cancer therapy” and everything to do with antineoplastons”

“Perhaps Burzynski proposed this “revolutionary” new idea in a peer-reviewed article that’s not indexed in PubMed, but if he did I couldn’t find it using Google and Google Scholar”

“(In fact when I entered “Burznski” and “personalized gene therapy” into Google Scholar, I got the article containing the transcript of Burzynski’s interview that I’m discussing at the top of the hit list!)”

I had to choke back a rising bile in the back of my throat as I read this

I mean, seriously, such a combination of arrogance (Gorski apparently thinking that he was the kind of person who could intelligently conduct a PubMed, Google, and Google Scholar search on personalized therapy and targeting genes for cancer)

Gorski’s ignorance of the entire field of Internet searches is breathtaking!

Let’s put it this way

Gorski was in graduate school 20 years ago, and was not taught back then how to do an Internet search

Gorski fumes:

“There’s a term called “oncogene,” which describes genes that, when either mutated or too much is made, can result in cancer”

“Robert Huebner and George Todaro first coined it in 1969, and the first oncogene, src, was described in 1970, twenty years before Burzynski claims to have understood that cancer is a genetic disease”

“The first tumor suppressor gene, the retinoblastoma gene, was characterized in 1986, at least six years before Burzynski’s apparent “revelation” that cancer is a “genetic disease.””

As usual, Burzynski and Internet searching was way ahead of Gorski

One wonders if he has ever bothered to read:

Pg. 25

1987 – Liau, M.C., Szopa, M., Burzynski, B., Burzynski, S.R. Chemosurveillance: A novel concept of the natural defense mechanism against cancer. Drugs Exptl Clin Res 1987;13 (suppl 1):71-76.

OR:

Pg. 24

1997Burzynski. S.R. Antineoplastons. oncogenes and cancer. Anti-Aging Medical Therapeutics, Vol.1. Klatz RM.
Goldman R. (Ed). Health Quest Publication 1997; Marina del Rey, CA. USA.
http://www.circare.org/info/bri/burzynski_fdauntitled_promo_2012.pdf
But THAT would have required Gorski to do a search on the word “oncogene(s)”
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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM326633.pdf
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former web-site screenshots:
http://www.circare.org/info/bri/burzynski_fdauntitled_promo_2012.pdf
——————————————————————
Stanislaw Rajmund Burzynski Publications:
https://stanislawrajmundburzynski.wordpress.com/2013/03/16/stanislaw-rajmund-burzynski-publications/

I find Rhys Morgan abnormally prehensile

TheSkeptiCritic (@TheSkeptiCritic) tweeted at 8:12pm – 16 Apr 13:
https://twitter.com/TheSkeptiCritic/status/324329482712391680
TheSkeptiCritic (@TheSkeptiCritic) tweeted at 6:03pm – 19 Apr 13:
https://twitter.com/TheSkeptiCritic/status/325384142667788288
TheSkeptiCritic (@TheSkeptiCritic) tweeted at 6:12pm – 19 Apr 13:
https://twitter.com/TheSkeptiCritic/status/325386501670199296
January 13, 2012

Rhys

“Burzynski: Morally reprehensible”

“I find Dr Stanislaw Burzynski morally reprehensible”

“I think this because his treatment is sold for extortionate amounts of money to vulnerable, dying cancer patients in their last months – sometimes bringing them thousands of miles away from the majority of their family – so they can be injected with a drug that’s been in development for more than 30 years, yet has no evidence base to support its use”

Extortionate compared to what?

What evidence do you want?

“We also know that he uses large amounts of chemotherapy in his clinic too but charging extortionate amounts of money for it”

Extortionate again?

Compared to what?

“Also, I think he is morally reprehensible because if he really has discovered a cure for various cancers, why the hell is he sitting on 30+ years of research when he could publish it and convince the scientific community that antineoplaston therapy is effective?”

What’s your point?

Are you saying that phase 2 clinical trials prove that a drug is EFFECTIVE?

“The FDA’s Drug Review Process:”

“Ensuring Drugs Are Safe and EFFECTIVE”

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2”

“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
“He has a moral duty to do so”

“Hell, even if the results are negative he has a moral duty given the amount of money he’s charging”

“If it turns out that his treatment is ineffective, he should put his hands up and state”

“Look guys, it was a hypothesis that just didn’t work out.”

“If it turns out that his treatment is ineffective, he’d be wise to donate the large sums of money he’s made to cancer research”

Exactly how much “large sums of money” has he made?

“Sure, it’d be humiliating to have his life’s work undone, but at the same time it means that cancer patients wouldn’t be misled into believing his treatment is effective”

Didn’t you say:

“We also know that he uses large amounts of chemotherapy … ”

and isn’t chemotherapy supposed to work?

“Another thing I don’t understand is why Burzynski’s patients/relatives of patients don’t demand that he publishes the results”

“They’re paying for this research to happen”

“Without their funds, Burzynski wouldn’t have been able to do the research”

“They funded it, so surely they have influence over whether he writes the trial up”

“Or am I just being too hopeful?”

“If I were in that situation and something appeared to be working, I’d want it to be written up to further scientific research so that more people could benefit”

So, you have a problem with waiting until ALL phase 2 clinical trials are completed before publishing the FINAL results?

He’s already provided preliminary reports and data during the phase 2 clinical trial process

“I have one thing to ask of you and one thing only”

“Tweet something along these lines:”

RT @rhysmorgan Burzynski has had more than 30 years to publish his data. Why doesn’t he prove antineoplastons work? http://rhysmorgan.co/2012/01/burzynski-morally-reprehensible
or

RT @rhysmorgan Burzynski has a moral duty to publish his data. If it works, it’ll be more widely available. http://rhysmorgan.co/2012/01/burzynski-morally-reprehensible
“or of course, phrase it in your own way”

Ahhh … what “The Skeptic” lemmings do best, retwit each other’s tweets like #Sheeple

“Also, if anyone knows of any way that could force Burzynski to present his data or hand it over to someone capable of writing it up”

“I’d appreciate your contact!”

Maybe you should catch up on your reading:

2/24/2013
http://www.skeptical.gb.net/blog/?p=1442
2/27/2013
http://www.skeptical.gb.net/blog/?p=1798
3/9/2013
http://twentyfirstfloormirror.wordpress.com/2013/02/27/dolcefino-burzynski-has-published-but-has-he
“Thanks”

A Film Producer, A Cancer Doctor, And Their Critics

Mr. Lipson,
I read your article with amusement.
Your suggestion that it’s “unusual for a film critic to be harassed (in my opinion) by a fan-film producer,” made me laugh.
The “alleged” film critic posted a video on YouTube with a number of inaccuracies and suspect material in it, which I have covered on my blog.
Labeling the “documentary” as a “fan-film” and the producer’s request that this “fact-challenged” video be taken down as “harassment,” (in my opinion) is quite a stretch.
The “vloggers” paranoid statement re “force me to give him my home address so that I can be the subject of legal harassment and intimidation by his lawyers and media thugs,” is hilarious.
Your comment that Burzynski is not an oncologist is irrelevant; unless you have evidence that oncologists are more intelligent than biochemists like Burzynski, who has an oncologist as a co-author on his 2003-2006 phase II clinical trial preliminary reports.
I wonder why you refer to Burzynski’s at least 36 cancer publications, as “few.”
Nor am I sure how you came up with one completed trial, unless you are expecting that any source you are using other than the National Cancer Institute (NCI) at the National Institutes of Health (NIH), to be correct.
Burzynski does not receive federal funding, and donations are not tax deductible, so the money for clinical trials has to come from some source.
Some of your vaunted Burzynski critics resort to adolescent name-calling on various social media and block and censor remarks by those who might question their “infallibility.”
That is why I use a pseudonym.
Thank you for making me laugh.
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Forbes

Fact-checking http://thehoustoncancerquack.com

HoustonCancerQuack proclaims:

“Fact-checking Burzynski II”

“DO YOU THINK YOU HAVE AN OPEN MIND?”

“DO YOU HAVE THE ALL THE FACTS?”

Let’s find out if they have all the “FACTS,” shall we?

“Basic claims about ANP”

“Antineoplastons are chemotherapy, regardless of what supporters say”

“Toxicity, reactions, and even patient deaths can and do happen due to their administration”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

“patient deaths can and do happen due to their administration”

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

Here is what the National Cancer Institute (NCI) at the National Institutes of Health (NIH) lists as POSSIBLE “Adverse Effects”:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
“The most common side effect of ANP, hypernatremia, is an effect of the sodium in the mixture”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “HYPERNATREMIA” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

Let’s see what we can find out about “HYPERNATREMIA,” shall we?

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive cancer center
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

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

Division of Endocrinology, Mayo Clinic

Support Care Cancer. 2013 Feb 13. [Epub ahead of print]
(Supportive Care in Cancer)

DOI
10.1007/s00520-013-1734-6

http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
This 3 month study of 3,446 patients in 2006 found that most of the HYPERNATREMIA (90 %) was acquired during hospital stay

HYPERNATREMIA in the U.S.:
http://www.nlm.nih.gov/medlineplus/ency/article/000394.htm
HYPERNATREMIA is the most common electrolyte disorder in the United States
In some cases, cancer may cause the condition

“In order to maintain their doses of ANP, patients are required to drink obscene amounts of water every day (some report up to 12 quarts or more)”

“If they fail to do so, they may lapse into unconsciousness or die”

Let’s put this in perspective

FACT: Some sources indicate:

1) A man should drink about
3 liters (101.44 ounces / 3 quarts 5.44 ounces) per day

{12 quarts = 384 ounces = 11.356 liters}

[12 quarts in 24 hours = 1/2 quart or 16 ounces per hour]

2) Extremely healthy kidneys could process about 30 ounces (approx .9 liters) of water in an hour

{30 ounces in 24 hours = 720 ounces}

[720 ounces = 22.5 quarts per day]

3) A person with healthy kidneys could develop water intoxication by drinking about 2 to 3 times what their kidneys can process

So, if extremely healthy kidneys could process about 30 ounces per hour and 12 quarts per day would require one to only drink 16 ounces per hour, that means one is being asked to drink 14 ounces less per hour than what extremely healthy kidneys could process

So even if one drinks more than 16 ounces per hour so that one does not have to be awake hourly, there is still opportunity to do that

Of course, there are certain other factors that might have to be taken into consideration depending on the patient

“There are two cases of children (Haley S. and Elizabeth K.) at The OTHER Burzynski Patient Group who have had strokes unrelated to their tumors, likely because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “STROKE” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

FACT: This is only an “opinion” until it is supported by “FACTS”

“For an example of a patient nearly overdosing, see Adam M’s story”

“Patients seem to often end up in the hospital because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “ENDING UP IN THE HOSPITAL” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

FACT: This is only an “opinion” until it is supported by “FACTS”

“A surgical oncologist, researcher and patient advocate explains why physicians question Dr. Burzynski’s methods:”

My blog explains WHY I question this physician:
http://www.stanislawrajmundburzynski.wordpress.com
“This physician and others declined to be interviewed for the movie because of Merola’s track record of slanted presentation and because of past threats issued by people hired by the Burzynski Clinic”

Past threats issued by people hired by the Burzynski Clinic”?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

excuses, Excuses, EXCUSES
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/david-h-gorskis-conspiracy-mongering-and-more-of-his-dr-stanislaw-burzynski-stories
“What was the “present” from skeptics that was alluded to in the movie?”

“The “present” the Skeptics for the Protection of Cancer Patients (SPCP) delivered to Burzynski on his birthday, was a donation of $14,500 to St Jude Children’s Hospital for research into childhood cancers”

“They challenged Dr. Burzynski to match their donation”

“He did not”

“In fact, some of the interviews in the movie (conducted after the FDA inspection of the Burzynski Clinic, mentioned at the end) were filmed after the fundraiser had been announced, so Merola seems to have deliberately omitted the whole truth, because he certainly was aware of it”

“Doesn’t sound so sinister now, does it?”

“Also, Burzynski got a card”

Want to know what that “PRESENT” really was?

Critiquing Bob Blaskiewicz
(#Burzynski Cancer is Serious Business, Part II)

https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
“Are skeptics really calling out cancer patients, ridiculing and harassing them?”

You tell me:

Sheila Herron (@Ac2cSheila) tweeted at 1:54pm – 31 Mar 12:

Peter Bowditch (@RatbagsDotCom) tweeted at 8:09pm – 19 Feb 13:

“What about the 2-hour rejection from The Lancet?”

“The vast majority of papers that get rejected from The Lancet are rejected within 48 hours thanks to an editorial pre-screening process”

“Most researchers are thankful for this courtesy because it allows them to resubmit to other journals more quickly”

“Why does Merola try to convince the audience that this is evidence of a conspiracy against Burzynski?”

Why bring it up if you really have nothing to add that is relevant?

FACT: The Lancet Oncology will not discuss any submission that may or may not have been submitted to The Lancet Oncology with anyone other than the corresponding author

To do so would constitute a breach in confidentiality

“Patients pay a lot of money upfront to enter his clinical trials, presumably believing that the trials will eventually be published”

Is that really the patients’
motivation?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

“Burzynski has never published the results of those trials but keeps the money:”

Really?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“Burzynski’s abysmal trial completion record, over sixty abandoned trials, the trust of every patient who participated betrayed”

“If trial completion were a batting average, he’d be batting .016”

Really?

FACTS:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951

http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
“His publication average is .000”

“Really:”
http://clinicaltrials.gov/ct2/results?term=burzynski&pg=1

REALLY?
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/david-h-gorskis-conspiracy-mongering-and-more-of-his-dr-stanislaw-burzynski-stories
“Speaking of harassment…”

“Merola does not mention that skeptics only caught wind of the Burzynski story in November 2011, after a teenaged blogger critical of the Clinic received phony legal threats from someone who had been hired by the Clinic to “clean up” its reputation”

“This person, Marc Stephens, sent this high school student images of his family’s home, the message clearly:”

“We know where you live.”

“These threats were well documented in the international press”

“Somehow Merola managed to not mention that in the movie”

Maybe it wouldn’t be so bad if the loquacious “teenaged” high school student got his “FACTS” straight:

TheSkeptiCritic (@TheSkeptiCritic) tweeted at 8:12pm – 16 Apr 13:
https://twitter.com/TheSkeptiCritic/status/324329482712391680

http://rhysmorgan.co/blog

http://rhysmorgan.co/burzynski-morally-reprehensible

http://thewelshboyo.wordpress.com
“What really happened to Amelia Saunders?”

“Merola suggests that Amelia Saunders died as a result of her parents taking her off of antineoplaston therapy, that there “confusion and disagreement” between the doctors in the UK and Houston’s reading”

Really?

FW (@frozenwarning) tweeted at 5:01am – 14 Mar 13:

Burzynski Movie (@BurzynskiMovie) tweeted at 12:38pm – 14 Mar 13:

Burzynski Movie (@BurzynskiMovie) tweeted at 1:09pm – 14 Mar 13:
http://t.co/AyHjRYZwEJ

Burzynski Movie (@BurzynskiMovie) tweeted at 1:34pm – 14 Mar 13:
http://t.co/Du1OrFENRS

Burzynski Movie (@BurzynskiMovie) tweeted at 11:49pm – 14 Mar 13:
http://t.co/wxU2PHJ3GD

“We hope this makes it clear that what you are seeing in the new Burzynski movie may not be entirely reliable”

So … like your blog?

“As we get more information about the claims in the movie, we will add additional rebuttals and provide context for understanding what really goes on at the Burzynski Clinic”
http://www.anp4all.com
I can’t wait
http://thehoustoncancerquack.com/fact-checking-burzynski-ii

David H. Gorski’s conspiracy-mongering and more of his Dr. Stanislaw Burzynski “stories”

Eric Merola’s conspiracy-mongering and more of Dr. Stanislaw Burzynski’s cancer “success” stories

David Gorski (@gorskon) tweeted at 5:23am – 15 Apr 13:
http://t.co/8Fb4GD7hkK’s-cancer-“success”-stories-part-2

Bob Blaskiewicz (@rjblaskiewicz) tweeted at 5:52am – 15 Apr 13:

ScienceBasedMed (@ScienceBasedMed) tweeted at 12:28pm – 15 Apr 13:
http://t.co/5MNwcmHEPW

ScienceBasedMed (@ScienceBasedMed) tweeted at5:35pm – 15 Apr 13:
http://t.co/5MNwcmHEPW

Because promoting it once just isn’t good enough

4/15/2013 David H. Gorski tweeted away about his blog, about Eric Merola’s second movie, about Stanislaw Burzynski, Burzynski: Cancer Is A Serious Business, Part 2

A ?

Or, as they might say in Toronto, Canada,

Aye ?

Maybe this is the “screening” title, as opposed to:

“Burzynski: Cancer Is Serious Business, Part II”

@Gorskon mentions the “Skeptic Mule,” Brian Thompson, from the James Randi Educational Foundation (jref)
http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html
@OracKnows implies that he took advantage of his supposedly “awesome” commentary about his experience on the JREF Swift Blog,
https://stanislawrajmundburzynski.wordpress.com/2013/04/02/finally-james-randi-educational-fund-jref-wins-an-award-that-they-richly-deserve
and his “alleged” “COPIOUS notes,” which I referred to in my blog:
https://stanislawrajmundburzynski.wordpress.com/2013/03/14/my-1st-hand-review-of-oracs-2nd-hand-review-burzynski-cancer-is-serious-business-part-ii
Gorski dishonestly demonizes what he refers to as “them” (i.e., Eric Merola) and mentions the skeptics promoted in Burzynski II, all with a heapin’ helpin’ of conspiracy-mongering

In this post, I will delve into a little more detail about the fundamental intellectual dishonesty behind Orac’s conspiracy-mongering

In particular, note how everything I said in my previous posts about what went on at the Q&A is verified, and, in fact, you now have the details

I will try to mention the specific time points to refer to as I go along

Also note that there is a segment at about the 47:45 mark in which JREF’s Brian Thompson (blurred out but still recognizable) speaks with the husband of one of Burzynski’s patients that is worth watching and that I will briefly discuss further into this post

3 things

3 things got me to thinking that I was probably due to write about Stanislaw Burzynski and his “Conspiracy Theory” propagandist Gorski again

The 1st thing, of course, was Gorski’s blog

The 2nd thing was the Q&A video

The 3rd thing was a rather odd online encounter that I had with @gorskon a couple of days ago

It was so bizarre that it left me scratching my head and thinking that @gorskon really needs to look at how he appears online

Either that, or he’s losing it

Regular readers probably remember that a couple of weeks ago I posted a shameless self-plug featuring a link to a YouTube video of a talk he did for the National Capital Area Skeptics on March 9 (which I can’t resist embedding my 21 point skidoo review blog again, for those of you who might not have seen it—forgive me):

Critiquing David H. Gorski – Quackademic Medicine
https://stanislawrajmundburzynski.wordpress.com/2013/04/02/critiquing-david-h-gorski-quackademic-medicine
apparently Merola saw the video too

It didn’t take long at all for @gorskon to get himself hence to Twitter to start tweeting:

David Gorski (@gorskon) tweeted at 10:08pm – 12 Apr 13:

David Gorski (@gorskon) tweeted at 7:34pm – 13 Apr 13:

which made me want to be sure to immortalize it

I’m not sure if it was embarrassment or a stab of conscience, but Gorski’s immortal comments where he mentions that Eric Merola had contacted him about appearing in Burzynski: Cancer Is Serious Business, Part 2, is now gone from his blog, or hiding from me:

Didymus Judas Thomas

#52 – Didymus Judas Thomas

At the Tu-Quack Center ScienceBasedMedicine Room

January 15, 2013

Don’t worry Orac, no one is going to mistake you for Vincent Kennedy McMahon; HE actually has a Gigantic Pair of Grapefruits! I find it amazing that you can communicate with EM about getting to say what you want to say, but then amazingly can’t communicate about not wanting any videos, music, pictures, or whatever else “Conspiracy Theory” misgivings you fear. It’s not about “Carpe Diem” for you, it’s about “Carpe Don’t!!” That’s just a “Piss-Poor” excuse!!!
http://scienceblogs.com/insolence/2013/01/14/the-story-of-sean-olaighin-patient-of-dr-stanislaw-burzynski
Gorski asks:

“On the other hand, what’s worse than being a white supremacist?”

Rubbishing the work of multiple M.D.’s and an oncologist ?

Posting

“Misinformation” ?

“Disinformation” ??

(Mis•Dis•Information)

“Misdirection” ???

@ScienceBasedMed
“Apparently I’m also a puppy eater”

David Gorski (@gorskon) tweeted at 12:07pm – 6 Apr 13:
http://t.co/CUJkMpw6jP

Maybe he meant you throw

“puppy Heaters” ?

David Gorski (@gorskon) tweeted at 2:29pm – 30 Mar 13:

David Gorski (@gorskon) tweeted at 2:33pm – 30 Mar 13:

David Gorski (@gorskon) tweeted at 8:35am – 31 Mar 13:

Such is life

However, @gorskon’s ill-considered Twitter adventures got me interested in what he might be up to again, as did learning that he blogged about a Q&A after a screening of Burzynski II in Toronto

Gorski blogged:

“As with Merola’s screening at San Luis Obispo on March 10, this screening in Toronto, which occurred on April 5, was attended by at least one skeptic, who was kind enough to do the same thing our colleagues did in California and provide me with notes”

I wonder if they were “COPIOUS notes” like he “allegedly” received previously?

I hope that my discussion of these blog comments, and Q&A’s and of these twits will serve, along with my previous discussions, as educational background for those who attend further screenings of the Burzynski movie, for example the upcoming screening on April 27 at the Newport Beach Film Festival

Davey doubles down on the conspiracy-mongering

“The very first thing I noticed upon viewing the YouTube video of the Q&A from March was that the sheer conspiracy mongering that Merola engages in was not adequately captured by the notes”

Those “alleged” “COPIOUS notes”?

THAT is truly, truly over the top

Gorski continues:

“For instance, take a look at the segment beginning at about the 13:56 mark, in which Merola discusses how former senior advisor to President Obama David Axelrod allegedly watched the film”

“Merola repeated this very same story near the very beginning of his Q&A in Toronto, although he apparently did preface it with a disclaimer to the effect of something like, “I have no proof of this”

“You can believe me or not.”

“Clearly, the David Axelrod story is going to be a regular feature of Merola’s movie publicity tour, and Merola plans on using it at every Q&A”

“I can only hope that my reporting on it last time led him to add that little disclaimer”

David Gorski (@gorskon) tweeted at 12:27pm – 30 Mar 13:

This is not a mistake

Another “delusion of grandeur”?

Gorski proceeds:

“More importantly, I would love to see whether David Axelrod will actually respond to this, particularly now that we have evidence that Merola is telling this story other than reports of promoters of science-based medicine who were brave enough to go into the veritable lions’ den a month ago”

“Brave enough” ?

“Lions’ Den” ??

really ? Seriously ?? REALLY ???

So, as opposed to you (NOT) appearing in Burzynski 2?

Gorski questions:

“Can you imagine how some of them would react to a pharmaceutical company advertising off-label uses for its drugs?”

Oh, wait

We don’t have to imagine it

We already know

It would be like Orac commenting on a pharmaceutical company being fined $3 BILLION?

Gorski blathers on

“Next up, if you don’t believe me when I told you last time just how much Merola despises anyone whom he considers to be a member of “The Skeptics,” just mosey on over to the segments at the 21:25 and 35:45 marks”

“At the 21:25 mark, Merola is asked, “How did you discover the skeptics’ group and how did you gain access to the videoconference and do you know anything else about them?””

Merola’s answer:

“Sure”

“Basically, these guys have no shame whatsoever”

“They have no problem letting everybody know their names and putting themselves out there”

“I really believe that the lower tier guys, like the guys that you saw, they put that on YouTube and were very proud of it”

“I went through a lawyer to get legal clearance to make sure I was safe”

“That’s why they’re blurred out and their names are hidden”

Gorski blogospheresplats:

“If you want to know the utter intellectual dishonesty of this answer, realize that the segment that Merola included in his movie of “skeptics plotting” was nothing more than a clip taken from the Virtual Skeptics podcast (episode 13, to be precise) in which Bob Blaskiewicz was talking about Burzynski and his plans to raise money for St. Jude’s for Burzynski’s 70th birthday in January”

What David fails to do is describe this birthday “present” in detail as I did on my blog:
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
Gorski blatherskites on:

“Also note the disconnect between the movie, which, according to reports, implies that skeptics—excuse me, “The Skeptics,” to use Merola’s term in his movie—are some shadowy cabal, while in the Q&A he admits that this stuff is on YouTube”

As if Bobby (Blatherskitewicz) Blaskiewicz’s and pals’ YouTube videos and blog which Merola specifically described as:

” … the LOWER TIER guys, like the guys that you saw, they put that on YouTube … ”

are the relevant part of the so-called

“shadowy cabal”

But none of that matters anyway because, apparently:

Skeptics are calling me an actress or an actor

Sheila Herron (@Ac2cSheila) tweeted at 1:54pm – 31 Mar 12:

Skeptics are saying I’m laundering money

Peter Bowditch (@RatbagsDotCom) tweeted at 8:09pm – 19 Feb 13:

What is going on?”

Gorski posits:

“I wonder if I’m one of the “guys at the top.””

“If I am, this is the first I’ve heard of it”

Don’t worry Davey

It’s a long way to the top if ya wanna Rock and Roll

and, you haven’t even made it to the chorus line

In other words, you’re not even

off, Off, OFf, OFF Broadway yet

“The Skeptics” (Burzynski: Cancer is Serious Business, Part II)
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics
Gorski blathersplats on:

“He goes on to complain about how skeptics have “completely hijacked” Burzynski’s Wikipedia page and how he really really wanted to “call them out,” but for “legal reasons” and “running time.””

Is THAT all you’ve got ?

THIS is just the tip of the bucket list:

“The Skeptics:” Your problem is, Wikipedia IS censored
https://stanislawrajmundburzynski.wordpress.com/2013/04/14/the-skeptics-your-problem-is-wikipedia-is-censored
But Gorski knows this, because when he blocked my comments on his blog, suddenly 2 “alleged” “gatekeepers” got “brave”

#174 – SW – 2/12/2013

[…]
anti-Burzynski “bloggers”
[…]

These individuals are also responsible for “gate keeping” the Wikipedia Page on The Burzynski Clinic

This issue, as well as the identities of those involved, will be covered in great length in the new 2013 “Chapter 2″ documentary

[…]
You will notice the “anti-Burzynski bloggers” refuse to do that or adhere to reputable sources
[…]

As one of those “gate keeping” wikipedians I find this quite laughable – not only the threat of “covering” my identity, but also the suggestion that bloggers and wikipedians (there may be an overlap, but I can assure you that I’m not a blogger) refuse to check and adhere to reputable sources

#203 – novalox – 2/13/2013

Now, let’s just wait and see djt make accusations of persecution and unfairness

Should be entertaining to see his attempts at this

Oh, BTW, djt, if you are still reading this, I was one of the Wikipedia editors who reported you for your trolling behaviors there

Have fun with that
http://scienceblogs.com/insolence/2013/02/08/will-the-fda-finally-slap-down-stanislaw-burzynski-for-good
Gorski splats:

“About 18 months ago, Burzynski made the huge mistake of siccing his attack Teacup Chihuaha Marc Stephens on a teen skeptic in the U.K. by the name of Rhys Morgan”

🙂

Oh !

The infamous “teen skeptic,” @rhysmorgan ?

TheSkeptiCritic (@TheSkeptiCritic) tweeted at 8:12pm – 16 Apr 13:
https://twitter.com/TheSkeptiCritic/status/324329482712391680

http://rhysmorgan.co/blog

http://rhysmorgan.co/burzynski-morally-reprehensible

http://thewelshboyo.wordpress.com
So, where’s your “FACTS” that “PROVE” that Burzynski “sicced” anyone on him?

Don’t have any as usual ?

Gorski rants on:

“When someone like Merola promises to slime me in a movie that will see international distribution, I take notice”

You mean you knew from the beginning that it would have “international distribution”?

Gorski racks up more frequent “conspiracy-mongering” flyer miles

“Around the 35:45 mark, Merola is asked who is paying “The Skeptics” and whether it’s been investigated”

Merola’s response:

“Yeah, I’ve done a lot of that myself, but frankly as you can imagine for legal reasons I just didn’t want to call them out”

“I’m not going to call them out”

“Not yet”

“I know who most all of them are”

“I know what they’re doing”

“But for legal reasons, because these guys are vicious and do not care about the truth—they only care about winning—and I don’t want to give them any reason to damage me any further or at all, frankly”

“So, yes, it’s been done, but they’re slippery, slippery people, and I’m not going to go any farther than that”

“But that would be a great thing, to have someone do a separate investigative report on just these guys, because most people—the festival staff, most people that watched it—said, “I’ve never even heard of these guys”

“I didn’t even know they existed.””

“Then they go back online, and they realize, wow, so they’re the ones doing all the damage online”

“They’re the ones doing this and that”

“That’s the best I can answer that”

“I’ve been trying to be careful myself, because they’re really nasty people”

Gorski theorizes:

“I was struck by how paranoid this sounded, even more so than I had expected based on reports I received”

Too bad you weren’t able to eruditely explain in detail how it’s supposedly “paranoid”

Gorski rambles:

“I was also further struck at how Merola describes Burzynski critics, who according to him are more than happy—proud, even—to “put their names out there” as “spineless,” when he himself has decided for legal reasons not to “name names.””

What would you like better ?

Liars ?

Cowards ??

Dissimulators ???

Gorski rattles off:

“One can’t help but wonder if maybe—just maybe—the reason Merola’s lawyers told him not to “name names” is because they realized that much of what he says is likely to be libelous”

Would you like me to do some of it for him?

Gorski ruminates:

“Certainly, I consider it so from what I’ve been able to gather”

But then again, you don’t believe in “Free Speech” on your blog

Stanislaw Rajmund Burzynski, M.D., Ph.D and “Freedom of Speech”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech

Gorski insists:

“In any case, what really bothers Merola is he knows damned well that I’ve actually read nearly every paper I can get my hands on about antineoplastons”

“I also have the skill set to analyze them, and I wasn’t impressed”

Like I have NOT been impressed by your lack of “fact-checking” and NOT backing up what you twit and blog about?

Gorski postulates:

” … their willingness becomes particularly problematic in the case of Tori Moreno”

“Moreno is a Burzynski patient from the late 1990s who is now 14 years old”

“She appeared in the video above and is scheduled to appear again with Eric Merola at the Newport Beach Film Festival screening, along with her parents”

“She was clearly nervous on stage, and it was clearly her father who was driving the bus, so to speak”

“I must admit that I have a real problem with her being used this way”

And in reference to adults he comments:

” … they are considered competent to make their own decisions with respect to speaking out”

“Such is not the case with an underage teen like Tori Moreno”

“From my point of view, poor Tori is being used as nothing more than a prop by Eric Merola and, sadly, her father to be presented as “living proof” that Burzynski’s therapy works”

So, Gorski “thinks” (?) Tori is NOT “competent” to make her “own decisions with respect to speaking out”

But is she?

(“Such is not the case with an underage teen like Tori Moreno”)

Well, NOT if you’re “Dr. Free Speech”

And that’s something that needs to be said publicly

Gorski thinks we’re supposed to be impressed by:

“According to the NCI, treatment options include:”

“Therapeutic options include watchful waiting; …”

which refers to patents with dates from 2004 and 2005 re a Burzynski patient being treated about 10 years before those patents, in 1995

So what to make of all this?

Lessons for those who would oppose “The Skeptics”

Gorski’s comments re:

The Q&A session at San Luis Obispo and what I’ve learned about the Q&A session after the Toronto screening of Burzynski II provide many lessons for unbiased individuals and critics of skeptics who don’t “fact-check”

First and foremost, to me, at least, is the lesson that David H. Gorski can’t be trusted

He is a true believer, and he despises fact-checking

For instance, he clearly plans on repeating that Eric Merola clearly plans on repeating an “unbelievable” story about David Axelrod, even though there is NO indication that David’s done due diligence

Like below where he states:

“He demonstrates time and time again that he does not understand science, clinical trials, or why science-based oncologists do not take Burzynski seriously”

I guess the people that work at these places do NOT “take Burzynski seriously” either:

3/2011 – PHASE II TRIAL of tipifarnib and radiation in CHILDREN with newly diagnosed diffuse intrinsic pontine GLIOMAS
http://www.ncbi.nlm.nih.gov/m/pubmed/21339191
University of California—San Francisco

Children’s Hospital Boston, Massachusetts

St Jude Children’s Research Hospital, Memphis, Tennessee

Seattle Children’s Hospital, Seattle, Washington

Children’s Hospital of Philadelphia, Pennsylvania

Children’s Hospital of Pittsburgh, Pennsylvania

Children’s National Medical Center, Washington, DC

Cincinnati Children’s Hospital Medical Center, Ohio

Neuro Oncol (2011) 13 (3): 298-306
doi: 10.1093/neuonc/noq202

http://neuro-oncology.oxfordjournals.org/content/13/3/298.full
Neuro Oncol (2011) 13 (3): 298-306. doi: 10.1093/neuonc/noq202
5.723 Impact Factor

REFERENCE:

25. ↵ BURZYNSKI SR

Treatments for astrocytic TUMORS in CHILDREN: current and emerging strategies

Paediatr Drugs. 2006;8:167-178
http://link.springer.com/article/10.2165%2F00148581-200608030-00003
Pediatric Drugs
May 2006, Volume 8, Issue 3, pp 167-178

He’s using every tool at his disposal and is willing to cherry pick and distort information, and in general demonstrate no regard for the truth

In other words, one thing that anyone who wants to criticize Gorski should know is that Gorski is not convincible, not trustworthy, and likely to use whatever internet sources he has to attack, and anyone who wants to confront Gorski at a Q&A with a critical question needs to be prepared for the types of spin he will bring to bear

In particular, that includes not giving him what I like to call a “weasel” opening that allows him to attack based on one mistake and ignore everything else

He’s very good at that

Gorski ejaculates:

“The problem is the quality (more specifically, the lack thereof) and utterly unconvincing nature of Burzynski’s publications”

“He publishes in bottom-feeding journals and has not yet published a completed phase II clinical trial”

“That’s plenty bad enough”

“Burzynski has only published abstracts and partial reports on phase II trials, none of which are particularly convincing”

“His publications are all, as far as I’ve been able to tell, crap, and I’ve read nearly all of them”

This leaves one to wonder why DHG does NOT cite any US Department of Health and Human Services (HHS), Food and Drug Administration (FDA), or National Cancer Institute (NCI) at the National Institutes of Health (NIH) document that supports his position as to the RELEVANCE of the Impact Factor of any journal Burzynski has or may publish in, nor does he back up his comments re the Preliminary Reports that Burzynski has published re the Phase II clinical trials:

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

2003 – 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/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101

6 months median duration of treatment

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003 – Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma

4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy

19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

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

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004 – Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

Integrative Cancer Therapies

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

13 children with recurrent disease or high risk

6 (46%) survived more than 5 years

2005 – Protocol – recurrent disease or high risk
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease

3/2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG

14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections

5 months median duration

Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

2007 – Recent clinical trials in diffuse intrinsic brainstem glioma

Review Article
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
E. Multitargeted therapy

Antineoplaston A10 injections (A10) consist of synthetic phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (isoPG) in a ratio 4:1

antineoplaston AS2-1 (AS2-1) consists of PG and phenylacetate sodium (PN) in a ratio of 1:4

Phase II studies with ANP included patients with DBSG began 1988
(Burzynski, 2004a)

Only small # of patients with DBSG involved in most studies, which dealt with broad spectrum of primary brain tumors
(Burzynski, 2004a)

1996, phase II study of ANP in patients with brainstem gliomas opened and nearing completion
(Burzynski et al, 2003, 2004a, 2007)

studies are conducted at Burzynski Clinic and monitored by FDA and Institutional Review Board (IRB)

most recent report describes results in children with newly diagnosed DBSG
(Burzynski et al, 2007)

20 evaluable patients
5 with high-grade gliomas

overall survival (OS)
2 years – 40%
5 years – 30%

CR – 30%
PR – 10%
SD – 20%
PD – 40%
(Burzynski et al, 2007)

study closed for accrual and final results will be evaluated before end of 2007

Phase III protocol currently under FDA’s review

Results summarized in Table 2

proposed antineoplastic activity of ANP in DBSG consists of targeted therapy affecting AKT2 and TGFB1 pathways (PG), RAS, TP53, and p21 (PN) MYCC (PG and PN), MAD (PG), INI1 (PG), and apoptosis (PG and isoPG)

PG is formed in patient’s liver from PN and PB, but doesn’t share with PN and PB an inhibitory affect on HDAC

details of these mechanisms have been described previously

(Castillo et al, 1991; Liau et al, 1992; Adam et al, 1995; Liu and Samid, 1995; Shack et al, 1995; Danesi et al, 1996; Gorospe et al, 1996; Prasanna et al, 1996; Adam et al, 1997; Engelhard et al, 1997; Harrison et al, 1998; Ng et al, 2000; Witzig et al, 2000; Li et al, 2001; Burzynski et al, 2003, 2004a,b, 2005; Waldbillig and Burzynski, 2003; Burzynski, 2004b, 2006a,b)

DBSGs remain some of most tragic diagnoses in oncology

general opinion of neuro-oncologists that results of treatment for DBSG constitute worst response in all primary brain tumors

DBSGs occur usually in children, in whom brain tumors in general are 2nd most frequent malignancy, and most common form of solid tumors

Due to poor response, # of clinical trials in DBSG is small, and there isn’t much interest in bringing new agents into approval process by pharmaceutical companies

Results of treatment with antineoplastons A10 and AS2-1 (ANP) in patients with diffuse, intrinsic brain stem glioma

Author – Burzynski et al, 2007
Phase II – Study Type
N – newly diagnosed tumor – Tumor Type
20 – # of patients
ANP – Treatment
ANP – antineoplastons A10 and AS2-1
Efficacy
overall survival
2 yrs / 5 yrs
40% / 30%
median survival time
16.4 – months

6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease

Most results of phase II trials with targeted therapy and ANP have been presented at oncology meetings and published as abstracts

It was decided to include data from meeting abstracts in order to present most up to date results, but they should be treated with caution until they pass scrutiny of peer review

Children, older than 3 years, and young adults with newly diagnosed tumors, are usually temporarily helped with standard radiation therapy, but it’s estimated that less than 10% of them will survive 2 years

Children, younger than 3 years, adults after age 40, and patients with high-grade glioma pathology have very grave prognosis, and median survival is similar to supratentorial GBM, or worse

Children diagnosed with DBSG and neurofibromatosis 1 have better prognosis, except those that show contrast-enhancement on MRI

prognosis is especially grave for patients with recurrent DBSG, who typically don’t survive longer than 6 months

Targeted radiotherapy and bevacizumab in combination with irinotecan may offer hope, but they would require further clinical trials

The patients with recurrent DBSG can be helped with treatments currently in phase II clinical trials

The results of phase II trials in DBSG with ANP compare favorably with responses and survival data in radiation therapy and chemotherapy trials

Currently conducted phase II studies are closed for accrual and nearing completion, and phase III studies are scheduled to open soon

Introduction of new multitargeted agents and acceleration of basic and clinical research in DBSG may offer better chances in the future

Ouch

I cringed
http://www.sciencebasedmedicine.org/index.php/dr-stanislaw-burzynskis-cancer-success-stories-part-2/#more-25645
Hopefully I didn’t fail to convey the full scope of “The Skeptics” true conspiracy theory awesomeness

That was awesome

The dishonesty of Guy Chapman, “The Skeptics” shill

The dishonesty of Guy Chapman,
“The Skeptics” shill
(@SceptiGuy @vGuyUK)

Dianthus Medical (@dianthusmed) tweeted at 4:53am – 12 Apr 13:
http://t.co/qGmGL5TcRO

“The dishonesty of Eric Merola, Burzynski shill”

“The fundamental characteristic of science is honest discourse”

“Dissenting opinion is encouraged, engaging with dissenting views is pretty much mandatory, at least if they are well founded”

“Skeptics usually follow the same principle with blog comments and the like”

“Obvious trolls do not usually get shut down unless their agitation becomes a significant burden on the site”

Obviously, “TROLLS” is a term that “The Skeptics” label anyone who questions their “infallibility” with, in order to supposedly buttress their questionable “reasoning” for not dealing with the questions they do not want to deal with, before they quickly change the subject

“This is by stark contrast with the world of quackery where nasty reality is not often not allowed to intrude”

As opposed to the stark contrast with the world of “The Skeptics” where nasty “rational reasoning” is not often allowed to intrude

“A new worst offender has come up in the shape of Burzynski shill and conspiracy whacknut Eric Merola”

As opposed to Guy Chapman who believes that a steel building like WTC7 collapsing is perfectly rational when hundreds and hundreds of architects and engineers disagree with him and he is unable to offer any example of any other steel building collapsing under such similar circumstances, or whether he is an architect or engineer more qualified that the aforementioned ones

Be that as it may,
maybe that’s how people think in the UK

“Merola ran a Q&A session around a screening of his propaganda movie”

“Some skeptics attended”

Like the “Skeptic Mule” who could not bother taking a minute out of their life to find out how the first movie was funded though it was clearly disclosed on the movie web-site
http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html
A blog which I awarded the first ever “PigASSus award for their adolescent voting option which allows viewers to vote on comments so that they are minimized and have to be maximized to view

If your viewers are so insecure that they need a voting option so they can “see no evil,” maybe you are too insecure to be running a blog:
https://stanislawrajmundburzynski.wordpress.com/2013/04/02/finally-james-randi-educational-fund-jref-wins-an-award-that-they-richly-deserve
“When they challenged on the provable absence of any randomised controlled trials, or any published outcomes from the sixty Phase II trials registered by Burzynski, there was an immediate cut to sinister music and obfuscatory web links that have already been addressed, content that does not address the issue f RCTs or failure to publish”

This is because individuals like Guy Chapman make a conscious decision to NOT do Internet searches in order to “Fact Check” before they “Insert Foot in Mouth”

3/28/3013 I had already addressed the Randomized question on my blog:
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
3/26/2013 I had already addressed the Phase II clinical trials on my blog:
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12
“This Gish Gallop is a standard tactic of Burzynski shills – every time they are challenged on the lack of published evidence they come up with the same list of conference abstracts, junk journals and so on, and every time they get the same response: that is not proper published evidence, where is the trial data?”

Not “proper published evidence” per WHO?

YOU?

YOU-WHO, you do NOT get to decide what is “proper published evidence”

“To find Merola editing a video to blatantly misrepresent the position of the reality-based community is hardly a surprise”

I am NOT quite certain what “reality” YOU are living in

“Needless to say, people asked questions in the Comments section of the YouTube video”

“And needless to say the comments were deleted”

If it was “needless to say,” why did you “say” it?

“Not just deleted, the commenters were immediately and summarily blocked from making any comment whatsoever on that video”

Reminds me of Orac’s YouTube video:
David H. Gorski – Quackademic Medicine, which had a video stream, and now does NOT have a video stream

“Hilariously, he then claimed that “skeptics don’t want to argue” – despite the fact that we have been arguing with him constantly on Twitter over these self-same misrepresentations!”

“Prize for best exposure of this idiocy goes to Adam Jacobs:”

THIS is the same Adam Jacobs who “creates” excuses for censoring comments, using “misinformation” and “disinformation” (MisDisInformation) and “misdirection,” as he did when I commented on Guy Chapman’s comments on his blog

Adam Jacobs March 16, 2013 at 8:40 am

“In the interests of transparency, I should point out that Didymus has left another comment which I’ve not approved

This is not something I do lightly:

I hate to censor comments, and believe firmly that everyone should have their say

However, the comment I consigned to the spam bin was another long, pointless, rambling one, with many irrelevant links

It doesn’t say anything of importance that Didymus hasn’t already said in his previous comments

I fear that Didymus is simply trying to make these comments unreadable by posting large quantities of irrelevance, and that’s something I really don’t think I can allow

Any future comments from Didymus with similar quantities of distraction material will be treated similarly”
http://dianthus.co.uk/burzynski-qa

Quidama (@IamBreastCancer) tweeted at 7:00pm – 9 Apr 13:

rjblaskiewicz:

rjblaskiewicz:

rjblaskiewicz:

Post #199 – Orac – 2/13/2013

“BTW, a certain commenter has been flooding the threads over the last 12 hours

His most recent comments are all in the moderation queue, but with more than 40 over the last 12 hours I probably won’t be releasing the vast majority of them, given how repetitive and inane they are

That would be a lot of annoying and obnoxious idiocy to release in such a short period of time, and if you look further upstream in this comment thread you’ll see that there’s already plenty of that from him there

Enough’s enough. I’m more tolerant of trolls and just plain obnoxious commenters than almost any blogger you’ll come across, but this is getting ridiculous”
http://scienceblogs.com/insolence/2013/02/08/will-the-fda-finally-slap-down-stanislaw-burzynski-for-good
“It’s astounding that Merola thinks he can get away with this kind of nonsense”

Yet “The Skeptics” have no qualms about trying to “get away with this kind of nonsense”

“Pretending that the ruthless suppression of any awkward questions like “where are the randomised controlled trials” and “where are the published results of the clinical trials conducted on humans, per the Helsinki Protocol” somehow equates to us not wanting to debate”

And yet curiously, Guy does NOT point out that the Declaration of Helsinki does NOT require a certain timetable be followed
http://www.wma.net/en/30publications/10policies/b3
“I think this is going to get really ugly when BBC’s Panorama runs an actual documentary (rather than a propaganda film) that is apparently in the works”

One man’s “propaganda” is another man’s “propergenda”

“This was expected soon but seems to be delayed, possibly because of the FDA raid about which Burzynski’s shills have made dark mumblings, and which was immediately followed by the removal of all reference to antineoplastons and trials from the content of the Burzynski clinic website”

THAT sure explains THIS:
http://www.burzynskiclinic.com/scientific-publications.html
Which is another item I had already addressed on my blog:
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page
“Tijuana beckons”

Or, probably in your case, Mad Dog 20/20
http://www.chapmancentral.co.uk/blahg/2013/04/the-dishonesty-of-eric-merola-burzynski-shill

Burzynski Clinical Trials (The SEC filings)

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

Company’s IND applications have been approved by FDA and Company’s conducting FDA-approved clinical trials

at present time all Burzynski’s patients are enrolled in FDA approved clinical trials or have FDA approval under special exceptions

medical chemical compounds composed of growth-inhibiting peptides, amino acid derivatives and organic acids which are known under trade name “Antineoplastons

Company’s currently conducting Phase II clinical trials of Antineoplastons

Burzynski has developed 6 formulations of natural Antineoplastons and 6 synthetic formulations of Antineoplastons

All Phase II clinical trials currently sponsored by Company involve use of 4 formulations of synthetic Antineoplastons known as A10 and AS2-1 in capsules and injections

Company currently conducting laboratory research involving new generation of Antineoplastons A10 and AS2-1

anticancer activity of compounds has been documented in preclinical studies employing methods of cell culture, pharmacology, cell biology, molecular oncology, experimental therapeutics and animal models of cancer

At level of clinical studies, Company believes that anticancer activity of Antineoplastons is supported by preliminary results from ongoing FDA authorized Phase II clinical trials

cellular mechanism underlying anticancer effects of Antineoplastons continues to be investigated in Company’s own basic preclinical research program and independent laboratories around the world

review of work suggests several mechanisms may underlie antineoplastic activity of Antineoplastons

it has been found, in cell culture experiments, that Antineoplastons induce pathologically undifferentiated cancer cells to assume more normal state of differentiation

Cell culture experiments have shown Antineoplaston components can kill some cancer cells by activating cell’s intrinsic “suicide” program

data collected in cell culture experiments may or may not indicate mechanism of action of Antineoplastons in humans

At more molecular or sub-cellular level, cell culture experiments have shown Antineoplastons can block biochemical pathways involving oncogenes required to produce abnormal cell growth

cell culture experiments have shown Antineoplastons can increase expression of anticancer tumor suppressor genes

experiments conducted using human cancer cells, they may or may not indicate mechanism of Antineoplaston action in humans

In addition to original family of Antineoplaston compounds (the “Parental Generation”), Company continues development of 2nd generation of Antineoplastons

In cell culture experiments 2nd generation Antineoplastons developed by Company, have been shown to be at least a thousand times more potent then Parental Generation

Company developing 3rd generation structurally altered Antineoplaston Company believes will exhibit markedly improved anticancer activity in human cancer cell lines resistant to Parental Generation

increases of antineoplastic activity in cell culture experiments may or may not translate into increased efficacy in humans

Company involved in ongoing studies examining pharmacokinetics (absorption, distribution, metabolism, and excretion) and pharmacodynamics (dose-response) of Antineoplastons in patients with neoplastic disease

Company primarily engaged in research and development of drugs currently being tested for use in treatment of cancer, and provides chemical consulting services

All clinical trials are conducted in Houston

One of clinical trials is for treatment of breast cancer using Antineoplaston A10 capsules in combination with FDA-approved drug Methotrexate

All other clinical trials are for treatment of wide variety of cancers using only combination of Antineoplastons A10 and AS2-1

In most trials intravenous formulations of Antineoplastons are used

In few other trials, oral formulations of Antineoplastons are used

All Company’s clinical trials, except study with Antineoplaston A10 and Methotrexate involve use of Historic Controls

Where tumor size is used as Milestone

clinical trial Protocol describes

“complete response” is complete disappearance of all tumors with no reoccurrence of tumors for at least 4 weeks

“partial response” is at least 50% reduction in size of total tumor size, with such reduction lasting at least 4 weeks

A “response” is either complete or partial response

“Stable disease” is less than 50% reduction in size but no more than 50% increase in size of tumor mass, lasting for at least 12 weeks

“Progressive disease” is more than 50% increase in total tumor mass or occurrence of new tumors

protocols of Company’s clinical trials are a 2-stage design, wherein 20 patients are initially to be accrued

After specified time period, if 0 responses by patients after 1st 20 patients, trial will be discontinued and drug declared to have less than desired activity

If at least one response, trial will be continued until 40 patients accrued

If study continues, following conclusions according to protocols based on 40 patients can be made:

If 3 or fewer responses, there’s less than desired activity

If there are 4 or more responses, there is sufficient evidence to conclude that Antineoplaston regimen used shows beneficial activity

There are no clinical trials being conducted that involve “double blind” studies and all but one clinical trial involve no randomization into multiple treatment groups

one randomized trial is of A10 capsules plus Methotrexate, a proven chemotherapy agent, in treatment of breast cancer

In trial, persons are randomized into one of 2 groups
one group receives Methotrexate alone
one group receives Methotrexate and A10 capsules

10/1997 only 2 clinical trials reached Milestone

These are

Clinical Trial BT-11
and
Clinical Trial BT-18

Clinical Trial BT-18 involving intravenous administration of Antineoplastons A10 and AS2-1 in treatment of “mixed glioma”, a type of PMBT

3/1996 – trial approved by FDA
results evaluated after 9 patients accrued

Of these there have been
2 complete responses
2 partial responses

Another trial of Clinical Trial BT-11 involves patients with brain stem glioma

trial approved by FDA 5/1996

12 patients accrual
1 complete
3 partial responses

there can be no assurance that results of

Clinical Trial BT-11
or
Clinical Trial BT-18

can be repeated or that other clinical trials will result in same or similar responses

Company intends to release updated information when it becomes available

one trial that’s retrospective is CAN-1 Clinical Trial of patients treated by Burzynski through 2/23/1996

analysis has been made of patients with PMBT in CAN-1 trial

40 evaluable patients
17 experienced more than 50% reduction in size of tumors of whom 7 had complete disappearance of tumor

FDA indicated it will not accept data generated by this trial since it wasn’t wholly prospective one

Notwithstanding response results of

Clinical Trial BT-11
and
Clinical Trial BT-18

management believes it’s likely that FDA may require additional clinical trials based upon

Clinical Trial BT-11
and
Clinical Trial BT-18

Protocols be conducted by institution not affiliated with Company or Burzynski before advising that NDA filing is warranted

AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BL-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE BLADDER
3 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BR-10 PROTOCOL FOR RANDOMIZED CONTROLLED TRIAL COMPARING METHOTREXATE TREATMENT ALONE TO THE COMBINATION OF METHOTREXATE AND ANTINEOPLASTON A10
7 40
4/12/97 – Revised
7/28/97 – Revised

BR-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE BREAST 17 40
7/20/96 – Revised
4/29/97 – Revised

BR-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN PATIENTS WITH ADVANCED BREAST CANCER
6 40
8/26/96 –
12/10/96 – Revised
4/12/97 – Revised

BR-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH HIGH GRADE GLIOMA
9 40
3/1996

BT-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH GLIOBLASTOMA MULTIFORME
34 40
3/1996;

BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised

BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA
15 40
5/15/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
5/10/97 – Revised

BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

BT-14 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM
3 40
5/17/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

BT-16 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH LOW GRADE ASTROCYTOMA
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

BT-17 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH OLIGODENDROGLIOMA
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised

BT-19 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NEUROFIBROMA AND SCHWANNOMA
0 40
4/14/97 – Revised

BT-20 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME
35 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN
TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised

BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN
TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised

BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY
GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-24 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH EPENDYMOMA
7 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-25 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CRANIOPHARYNGIOMA
0 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-26 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CHOROID PLEXUS NEOPLASM
1 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-27 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH GERM CELL TUMOR OF THE BRAIN
0 40
5/15/96 –
11/18/96 – Revised
4/14/97 – Revised

BT-28 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN PATIENTS WITH MENINGIOMA
2 40
5/17/96 –
9/10/96 – Revised
4/14/97 – Revised

CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH REFRACTORY MALIGNANCIES
133 133
7/11/96 – Revised

CO-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE COLON
12 40
7/9/96 – Revised
9/7/96 – Revised
(RE-2 was added to this Protocol)
4/14/97 – Revised

CO-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 CAPSULES IN PATIENTS WITH ADENOCARCINOMA OF THE COLON
4 40
8/12/96 – Revised
12/2196 – Revised

ES-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE
ESOPHAGUS
4 40
7/9/96 – Revised
9/10/96 – Revised
10/30/96 – Revised
4/14/97 – Revised

HB-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH HEPATOBLASTOMA
7/8/96 – Revised
9/10/96 – Revised
3/2/97 – Revised
4/14/97 – Revised

HE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 IN PATIENTS WITH PRIMARY LIVER CANCER
1 40
2/12/97 – Origination date
5/28/97 – Revised

HN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE HEAD AND NECK
6 40
7/9/96 – Revised
9/10/96 – Revised
11/6/96 – Revised
added Children’s Informed Consent,
Revised 4/14/97 –

LA-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE LUNG
13 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
6/26/97 – Revised

LA-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH LARGE CELL, UNDIFFERENTIATED CARCINOMA OF THE LUNG
4 40
7/20/96 – Revised
9/28/96 – Revised
12/11/96 – Revised
4/14/97 – Revised

LA-5 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRONCHIAL ALVEOLAR CARCINOMA OF THE LUNG
1 40
7/20/96 – Revised
9/28/96 – Revised
12/11/96 – Revised
4/14/97 – Revised

LA-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE LUNG
5 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

LA-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SMALL CELL CARCINOMA OF THE LUNG
2 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

LA-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN PATIENTS WITH NON SMALL CELL LUNG CANCER
9 40
8/12/96 – Revised
9/9/96 – Revised
12/9/96 – Revised

LY-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA
2 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

LY-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, LOW GRADE
18 40
6/22/96 – Revised
8/12/96 – Revised
9/28/96 – Revised
10/23/96 – Revised
5/11/97 – Revised

LY-7 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, INTERMEDIATE GRADE
10 40
6/22/96 – Revised
8/12/96 – Revised
9/28/96 – Revised
10/23/96 – Revised
4/14/97 – Revised

LY-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NON-HODGKIN’S LYMPHOMA, HIGH GRADE
1 40
6/22/96 – Revised
5/11/96 – Revised

LY-9 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MANTLE ZONE LYMPHOMA
4 40
6/22/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

LY-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 WITH CHRONIC MYELOGENOUS LEUKEMIA
0 40
10/4/96 – Revised
4/14/97 – Revised

LY-11 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MYCOSIS FUNGOIDES – SEZARY SYNDROME
0 40
9/10/96 – Revised
4/14/97 – Revised

LY-12 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
0 40
9/10/96 – Revised
4/14/97 – Revised

LY-13 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH PRIMARY LYMPHOMA OF THE GASTROINTESTINAL TRACT
0 40
9/10/96 – Revised
4/14/97 – Revised

LY-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 INFUSIONS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
5/22/96 – Revised
9/18/96 – Revised
12/9/96 – Revised
4/14/97 – Revised

MA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MESOTHELIOMA
4 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT MELANOMA
8 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

MF-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT FIBROUS HISTIOCYTOMA
0 40
6/1997

MM-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MULTIPLE MYELOMA
5 40
7/26/96 – Revised
10/2/96 – Revised

MW-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH MACROGLOBULINEMIA OF WALDESTROM
0 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

NB-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH NEUROBLASTOMA
1 40
Orig: Dec 6, 1996
2/13/97 – Revised
4/14/97 – Revised

NE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH NEUROENDOCRINE TUMORS
3 40
7/9/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

OV-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE OVARY
5 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

PA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE PANCREAS
11 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

PN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMOR OUTSIDE THE CENTRAL NERVOUS SYSTEM
1 40
Orig: Dec 6, 1996
2/10/97 – Revised
4/14/97 – Revised

PR-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
11 40
7/5/96 – Revised
10/3/96 – Revised
7/9/97 – Revised
10/14/97 – Revised

PR-5 PHASE II STUDY OF ADENOCARCINOMA OF THE PROSTATE WITH ANTINEOPLASTON A10 AND AS2-1 CAPSULES
16 40
5/16/96 – Revised
7/29/96 – Revised
10/3/96 – Revised
10/14/97 – Revised

PR-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN COMBINATION WITH TOTAL ANDROGEN BLOCKADE IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
0 40
8/1/97;
8/25/97 – Revised

PR-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
0 40
7/5/96 – Revised
9/10/96 – Revised
4/14/97 – Revised
10/14/97 – Revised

RN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE KIDNEY
9 40
7/20/96 – Revised
9/28/96 – Revised
10/25/96 – Revised
4/14/97 – Revised

SA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH SOFT TISSUE SARCOMA
8 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – revised

SI-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE SMALL INTESTINE
1 40
7/9/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

ST-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ADENOCARCINOMA OF THE STOMACH
6 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

UC-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE UTERINE CERVIX AND/OR VULVA
8 40
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

UP-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF AN UNKNOWN PRIMARY
6 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

WT-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH WILMS’ TUMOR
2 40
7/8/96 – Revised
9/10/96 – Revised
4/14/97 – Revised

3/1/1997 Company entered into research funding agreement with Burzynski and terminated all royalty, rent, administrative services and supply agreements entered into 1/23/1992

Under research funding agreement Company agrees to undertake all scientific research in connection with development of new or improved Antineoplastons for treatment of cancer and other diseases

Company will hire personnel as required to fulfill obligation

Burzynski agrees to fund all basic research Company undertakes in connection with development of other Antineoplastons or refinements to existing Antineoplastons for treatment of cancer and other diseases

Burzynski agrees to pay expenses to conduct clinical trials

Burzynski agrees to provide Company laboratory and research space and office space at no charge

Burzynski may fulfill obligation in part by providing administrative staff for Company to manage business, at no cost

Burzynski agrees to pay full amount of monthly and annual budget or expenses for operation together with unanticipated but necessary expenses which Company incurs

3/1/1997 Company entered into research funding agreement with Burzynski and terminated all aforementioned agreements

term of Research Funding Agreement is one year, and automatically renewable for 3 additional one year terms, unless one party notifies other at least 90 days prior to expiration of term of agreement of intention not to renew agreement

In addition to termination provisions, agreement automatically terminates in event Burzynski owns less than 50% of outstanding shares of Company, or removed as President and/or Chairman of Board of Company, unless notifies in writing of intention to continue agreement notwithstanding automatic termination provision

Pursuant to Research Funding Agreement:

o Company agreed to undertake all scientific research in connection with development of new or improved Antineoplastons for treatment of cancer and other diseases

Company will hire personnel required to fulfill obligations under agreement

o Burzynski agreed to fund in entirety all basic research which Company undertakes in connection with development of other Antineoplastons or refinements to existing Antineoplastons for treatment of cancer and other diseases

o Burzynski agreed to pay expenses to conduct clinical trials

o Burzynski agreed to provide laboratory and research space, office space at facility, at no charge

o parties agreed Burzynski may fulfill obligations in part by providing administrative staff to manage business, at no cost

o Burzynski agreed to pay full amount of monthly and annual budget or expenses for operation of Company, together with other unanticipated but necessary expenses which Company incurs

Payments from Burzynski to Company of monthly budget made in 2 equal installments on 1st and 15th of each month

3/25/1997 Company and Burzynski entered into Royalty Agreement amended 9/29/1997, pursuant to which Burzynski agreed to act as principal clinical investigator of clinical trials necessary for obtaining FDA approval for interstate marketing and distribution of Antineoplastons

Payments made to Burzynski for 20% of cost of chemicals used in clinical trials being conducted by Burzynski 3/1/1996 – 2/28/1997

Burzynski is acting as principal investigator during clinical trials pursuant to 3/25/1997 Royalty Agreement between Company and Burzynski

11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing

12/10/1997
http://www.siliconinvestor.com/readmsg.aspx?msgid=2965068
Burzynski Research Institute Advances Clinical Trials for New Cancer Treatment and Completes New SEC Filing

HOUSTON–(BUSINESS WIRE)
12/10/1997–Burzynski Research Institute Inc.

Company announced new clinical trial earlier this year for experimental drugs, ANTINEOPLASTONS, for treatment of liver cancer

Company plans to submit results of current clinical trials to FDA 1/1998

If FDA finds results of trials sufficiently promising, Burzynski Research Institute Inc. will initiate procedure to generate data which will support New Drug Application (NDA)

BRI retained services of Brewer-Gruenert Capital Advisors, L.L.C., in Houston, to guide Company in preparing for expected growth based upon expectations of positive results of latest round of clinical trials

currently conducting approximately 72 FDA approved clinical trials

12/10/1997 – Burzynski Research Institute is sponsoring 72 Phase II Clinical Trials of ANTINEOPLASTONS in treatment of variety of cancer types and advanced stages

Early clinical results indicate particular promise with malignant brain tumors and lymphomas

interim analysis of 3 clinical studies indicates that 33% to 50% of evaluable brain tumor patients accomplished either complete tumor elimination or reduction of tumor size by more than 50%

5/31/2000
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-514477.txt
5/31/2000 5/31/1999
10QSB
5/31/2000 – CONFORMED PERIOD OF REPORT
5/11/2001 – FILED AS OF DATE

STANDARD INDUSTRIAL CLASSIFICATION:

IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]

5/31/2000 – quarterly period ended

currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs which are regulated by FDA

Company currently conducting 72 FDA approved clinical trials

5/31/2001 (7/12/2001)
http://www.sec.gov/Archives/edgar/data/724445/0000912057-01-523630.txt
CONFORMED PERIOD OF REPORT: 5/31/2001
FILED AS OF DATE: 7/12/2001
10QSB

Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations, however, at this time none of antineoplaston drugs have received FDA approval

significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs regulated by FDA

Company believes Antineoplastons are useful in treatment of human cancer and other diseases of body and is currently conducting Phase II clinical trials of Antineoplastons

Burzynski’s medical practice has
successfully funded Company’s research activities over last 17 years and, in 1997, medical practice was expanded to include traditional cancer #Burzynskitreatment options such as chemotherapy, 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 Antineoplaston clinical trials

As result of expansion of Burzynski’s medical practice, financial condition of medical practice has improved Burzynski’s ability to fund Company’s operations

Company currently conducting 72 FDA approved clinical trials

5/31/2002 – quarterly period ending
http://www.sec.gov/Archives/edgar/data/724445/0000912057-02-027187.txt
5/31/2002 – CONFORMED PERIOD OF REPORT
7/12/2002 – FILED AS OF DATE
FORM 10-QSB

Company is currently conducting clinical trials on various antineoplastons in accordance with FDA regulations

A significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs which are regulated by FDA

Company is currently conducting approximately 72 FDA approved clinical trials

1/14/2003 – Filing Date
11/30/2002 – Period of Report
http://pdf.secdatabase.com/1129/0001047469-03-001370.pdf

currently conducting clinical trials on various antineoplastons in accordance with FDA regulations

currently conducting approximately 72 FDA approved clinical trials

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

2003 – 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/m/pubmed/12718563

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

6 months median duration of treatment

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003 – Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report

http://www.ncbi.nlm.nih.gov/m/pubmed/15563234

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

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma

4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy

19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

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

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004 – Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

11/10/2004
http://www.sec.gov/Archives/edgar/data/724445/000104746904033767/0001047469-04-033767.txt
Burzynski Research Institute, Inc., announced signing Financial Advisory and Consulting Agreement with Millennium Energy Ventures.com, LLC (“MEVCO”)

Agreement provides BRI with access to MEVCO’s advisory services related to manufacturing realignment, pharmaceutical plant expansion, corporate focus and other consulting services to support FDA approval process for Antineoplastons A10 and AS2-1 for treatment of brain stem glioma

Press Release
11/9/2004
“Burzynski Research Institute, Inc. and Millennium Energy Ventures.com, LLC Sign Agreement

HOUSTON, TX
Burzynski Research Institute, Inc. and Houston based Millennium Energy Ventures.com, LLC, (MEVCO) announced today signing of Financial Advisory and Consulting Agreement that provides BRI with access to MEVCO’s advisory services related to manufacturing realignment, pharmaceutical plant expansion, corporate focus and other consulting services to support FDA approval process for Antineoplastons A10 and AS2-1 for treatment of brain stem glioma

This agreement is part of BRI’s strategy to facilitate fast track completion of necessary FDA approval process to bring treatment to the market place

Millennium EnergyVentures.com, LLC, is focused on providing financial and management expertise to technology-oriented growth companies in Energy and Medical sectors

firm focuses primarily on
energy technology markets including:

Enabling Technologies and Infrastructure, Power, Water, Communications, Oil and Gas, and Life Sciences

11/30/2005 – For the quarterly period ended
http://edgar.secdatabase.com/1472/95012906000296/filing-main.htm

significant portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, regulated by FDA

Company is currently conducting 35 FDA-approved clinical trials

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

3/2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma

http://www.ncbi.nlm.nih.gov/m/pubmed/16484713

Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG

14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections

5 months median duration

Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

5/31/2007 – quarterly period ended
http://edgar.secdatabase.com/1173/110465907054073/filing-main.htm

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

A portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

currently conducting 27 FDA-approved clinical trials

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

2007 – Recent clinical trials in diffuse intrinsic brainstem glioma

Review Article

http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html

E. Multitargeted therapy

Antineoplaston A10 injections (A10) consist of synthetic phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (isoPG) in a ratio 4:1

antineoplaston AS2-1 (AS2-1) consists of PG and phenylacetate sodium (PN) in a ratio of 1:4

Phase II studies with ANP included patients with DBSG began 1988
(Burzynski, 2004a)

Only small # of patients with DBSG involved in most studies, which dealt with broad spectrum of primary brain tumors
(Burzynski, 2004a)

1996, phase II study of ANP in patients with brainstem gliomas opened and nearing completion
(Burzynski et al, 2003, 2004a, 2007)

studies are conducted at Burzynski Clinic and monitored by FDA and Institutional Review Board (IRB)

most recent report describes results in children with newly diagnosed DBSG
(Burzynski et al, 2007)

20 evaluable patients
5 with high-grade gliomas

overall survival (OS)
2 years – 40%
5 years – 30%

CR – 30%
PR – 10%
SD – 20%
PD – 40%
(Burzynski et al, 2007)

study closed for accrual and final results will be evaluated before end of 2007

Phase III protocol currently under FDA’s review

Results summarized in Table 2

proposed antineoplastic activity of ANP in DBSG consists of targeted therapy affecting AKT2 and TGFB1 pathways (PG), RAS, TP53, and p21 (PN) MYCC (PG and PN), MAD (PG), INI1 (PG), and apoptosis (PG and isoPG)

PG is formed in patient’s liver from PN and PB, but doesn’t share with PN and PB an inhibitory affect on HDAC

details of these mechanisms have been described previously

(Castillo et al, 1991; Liau et al, 1992; Adam et al, 1995; Liu and Samid, 1995; Shack et al, 1995; Danesi et al, 1996; Gorospe et al, 1996; Prasanna et al, 1996; Adam et al, 1997; Engelhard et al, 1997; Harrison et al, 1998; Ng et al, 2000; Witzig et al, 2000; Li et al, 2001; Burzynski et al, 2003, 2004a,b, 2005; Waldbillig and Burzynski, 2003; Burzynski, 2004b, 2006a,b)

DBSGs remain some of most tragic diagnoses in oncology

general opinion of neuro-oncologists that results of treatment for DBSG constitute worst response in all primary brain tumors

DBSGs occur usually in children, in whom brain tumors in general are 2nd most frequent malignancy, and most common form of solid tumors

Due to poor response, # of clinical trials in DBSG is small, and there isn’t much interest in bringing new agents into approval process by pharmaceutical companies

Results of treatment with antineoplastons A10 and AS2-1 (ANP) in patients with diffuse, intrinsic brain stem glioma

Author – Burzynski et al, 2007
Phase II – Study Type
N – newly diagnosed tumor – Tumor Type
20 – # of patients
ANP – Treatment
ANP – antineoplastons A10 and AS2-1
Efficacy
overall survival
2 yrs / 5 yrs
40% / 30%
median survival time
16.4 – months

6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease

Most results of phase II trials with targeted therapy and ANP have been presented at oncology meetings and published as abstracts

It was decided to include data from meeting abstracts in order to present most up to date results, but they should be treated with caution until they pass scrutiny of peer review

Children, older than 3 years, and young adults with newly diagnosed tumors, are usually temporarily helped with standard radiation therapy, but it’s estimated that less than 10% of them will survive 2 years

Children, younger than 3 years, adults after age 40, and patients with high-grade glioma pathology have very grave prognosis, and median survival is similar to supratentorial GBM, or worse

Children diagnosed with DBSG and neurofibromatosis 1 have better prognosis, except those that show contrast-enhancement on MRI

prognosis is especially grave for patients with recurrent DBSG, who typically don’t survive longer than 6 months

Targeted radiotherapy and bevacizumab in combination with irinotecan may offer hope, but they would require further clinical trials

The patients with recurrent DBSG can be helped with treatments currently in phase II clinical trials

The results of phase II trials in DBSG with ANP compare favorably with responses and survival data in radiation therapy and chemotherapy trials

Currently conducted phase II studies are closed for accrual and nearing completion, and phase III studies are scheduled to open soon

Introduction of new multitargeted agents and acceleration of basic and clinical research in DBSG may offer better chances in the future

http://www.wikinvest.com/stock/Burzynski_Research_Institute_(BZYR)/Liquidity_Capital_Resources
Since 2009, permission for final phase of FDA clinical testing to allow Antineoplastons to be “FDA-approved” has been granted

only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in Phase 3 trials, claiming it would be “unethical” not to do so

In 2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close

Phase III trials are 3rd and final phase before reaching FDA approval

trials could begin worldwide in 2010, barring ability to raise money to fund them

FDA has officially mandated that some patients participating in these Phase III trials be subjected to radiation treatment while simultaneously receiving Antineoplaston treatment—claiming it would be “unethical” not to do so

1/13/2009 Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy, Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma
EX-99.1 4 a09-2965_1ex99d1.htm EX-99.1
Exhibit 99.1
HOUSTON, TX – 1/13/2009 – Burzynski Research Institute, Inc. today announced its reached an agreement with US FDA that enables company to move forward immediately with pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

Antineoplaston therapy (ANP) uses synthetic version of naturally occurring peptides and amino acid derivatives found in human body to target and control cancer cells without destroying normal cells

agreement was made under FDA’s Special Protocol Assessment (SPA) procedure and means that design and planned analysis of Phase III study is acceptable to support a regulatory submission seeking new drug approval

“We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant and challenged further by severely limited treatment options and clinical trials that could expand and discover new, efficacious therapies,”

said Burzynski

“The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management.”

“BRI has reached important milestone independently without financial backing from government, and without major pharmaceutical partner—a unique accomplishment in the oncology field

From inception, we’ve been committed to developing a targeted gene therapy option that’s less aggressive on the body than conventional therapies and have made considerable progress on steps mandated by FDA to bring a new drug to a patient community and cancer type that has unmet needs.”

About Phase III study

primary objective of randomized study is to compare overall survival of children with newly-diagnosed diffuse intrinsic brainstem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) & AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone

DBSG are considered to be 1 of most difficult types of cancer to treat

It combines highly malignant characteristics with very difficult location of brainstem

DBSG are inoperable because they involve most of brainstem (diffuse and intrinsic)

Number of children in US with brainstem gliomas is approximately 660

Absent treatment, survival rate from time of diagnosis is 6 months or less

At present, there are no standard curative treatments for the disease

RT is only treatment that may slow its progress, but at 2 years 93% of children with this type of cancer die, and none survive for 5 years

Other conventional treatments such as chemotherapy have generally been tried in clinical trials but are shown to be ineffective

There are no pharmacological treatments approved for DBSG at this time

Research and development efforts are focused on basic ANP research and 19 Phase II clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465909043323/0001104659-09-043323-index.htm
For quarterly period ended 5/31/2009
5/31/2009 – Period of Report
7/15/2009 – Filing Date Changed
Form 10-Q

12/2/2008 Company announced orphan drug designation of Antineoplastons A10 and AS2-1 was expanded to treatment of all gliomas

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

Company is currently conducting 12 FDA-approved clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465909059014/0001104659-09-059014-index.htm
quarterly period ended 8/31/2009
8/31/2009 – Period of Report
10/15/2009 – Filing Date Changed
Form 10-Q – Quarterly report

9/9/2009 Company entered into Clinical Study Agreement with University of Alabama at Birmingham pursuant to which Company retained University to provide following services in connection with clinical trials of Antineoplastons:

develop and implement statistical plans

analyze and manage data

review and amend Case Report Forms (CRFs)

prepare statistical reports for Data Safety Monitoring Boards (DSMB) and US FDA

services will be performed for certain protocols listed in Agreement

Agreement will terminate at completion of protocols listed in Agreement, however, either party may terminate Agreement, with or without cause, by giving 30 calendar days’ prior written notice

5/1/2007 – 8/31/2009 – $24,641 – Company paid University for services previously provided which was accrued during 3 month period ended 8/31/2009

Subsequent services are billed to Company on monthly basis

All rights, title and interest in all data and reports generated in performance of services, pursuant to Agreement, are sole and exclusive property of Company

Company intends to enter into clinical development agreement with contract research organization for services relating to Phase III clinical study, including initially a feasibility analysis of patient enrollment and site requirements of planned study

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

Company is currently conducting 12 FDA-approved clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910031825/0001104659-10-031825-index.htm
fiscal year ended 2/28/2010
2/28/2010 – Period of Report
6/1/2010 – Filing Date Changed
Form 10-K

Burzynski has developed 6 formulations of natural Antineoplastons and 6 synthetic formulations of Antineoplastons

All Phase II clinical trials currently sponsored by Company involve use of 4 formulations of synthetic Antineoplastons known as A10 and AS2-1 in capsules and injections

Company is also conducting laboratory research involving new generations of Antineoplastons A10 and AS2-1

Orphan Drug Designation

9/7/2004 FDA granted “orphan drug” status to Company’s Antineoplastons under Orphan Drug Act of 1983

In enacting Orphan Drug Act of 1983, Congress sought to provide incentives to promote development of drugs for treatment of rare diseases

drug may be considered for orphan drug designation if drug is intended to treat rare disease or condition affecting fewer than 200,000 people in US or, even if drug treats a disease affecting more than 200,000 people in US, drug isn’t expected to be profitable from sales in US

Subject to applicable laws and regulations, 1st sponsor to obtain FDA marketing approval for a drug with orphan drug designation for designated disease or condition receives limited marketing exclusivity for 7 years; no other sponsor may bring to market “same drug” for treatment of same disease or condition for period of 7 years from date application is approved by FDA

drug with orphan drug designation must meet same criteria for safety and efficacy as drug without orphan drug designation

Company began Phase II clinical studies in 1994 with 4 studies

At that time, a number of patients were also receiving Antineoplastons at Burzynski’s clinic in Houston, Texas (the “Burzynski Clinic”) outside clinical trials

2/23/1996 FDA requested that all then-current patients of Burzynski Clinic desiring to continue Antineoplaston treatment be admitted to Phase II Study, according to Protocol CAN-1

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
quarterly period ended 5/31/2010
5/31/2010 – Period of Report
7/15/2010 – Filing Date Changed
Form 10-Q

Company is primarily engaged as research and development facility for Antineoplaston drugs being tested for use in treatment of cancer

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of brainstem glioma

2008 FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for the treatment of all glioma

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910001658/0001104659-10-001658-index.htm
quarterly period ended 11/30/2009
11/30/2009 – Period of Report
1/14/2010 – Filing Date Changed
Form 10-Q

Company is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations

9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of brainstem glioma

During 2008, FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treatment of all gliomas

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs, which are regulated by FDA

Company is currently conducting 12 FDA-approved clinical trials

http://www.sec.gov/Archives/edgar/data/0000724445/000110465910038168/0001104659-10-038168-index.htm
quarterly period ended 5/31/2010
5/31/2010 – Period of Report
7/15/2010 – Filing Date Changed
Form 10-Q

portion of Burzynski’s patients are admitted and treated as part of clinical trial programs regulated by FDA

Company believes Antineoplastons are useful in treatment of human cancer and currently conducting Phase II clinical trials of Antineoplastons relating to treatment of cancer

Upon completion of assessment, randomized, international phase III study will commence

9/2004 Company announced FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for treating patients with brainstem gliomas

1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)

agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval

2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

Upon completion of assessment, randomized, international phase III study will commence

study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone

Company is currently conducting 5 FDA-approved clinical trials

8/31/2010 (10/15/2010) 10-Q
http://edgar.secdatabase.com/541/110465910052441/filing-main.htm
8/31/2010 quarterly period ended

Company is currently conducting 5 FDA-approved clinical trials

A10 & AS2-1 in children w/high grade glioma

19 – Ptnts Accrued
11 – Evaluable Ptnts
1 / 19.1% – #&% of Ptnts Show Complete Resp
3 / 27.3% – #&% of Ptnts Show Partial Resp
3 / 27.3% / #&% of Ptnts Show Stable Disease
4 / 36.4% – #&% of Ptnts Show Progress Disease

Certain prospective protocols which have reached a Milestone as of May 1, 2012

The results of Protocols
BT-06
BT-07
BT-08
BT-09
BT-10
BT-11
BT-12
BT-13
BT-15
BT-18
BT-20
BT-21
BT-22
BT-23
are set forth below (as of May 1, 2012)

A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma

Optic Nerve Glioma
Drug: Temozolomide
Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
Phase 3

ClinicalTrials.gov Identifier:
NCT01260103
“Optic Pathway Glioma”
5% of all childhood tumors

http://www.ncbi.nlm.nih.gov/m/pubmed/22607912

Today is “Rare Disease” Day
http://rarediseases.info.nih.gov/GARD/Condition/4107/Optic_pathway_glioma.aspx

NCT01260103 (BRI-BT-54)
http://www.clinicaltrials.gov/ct2/show/record/NCT01260103?term=Burzynski&rank=61

Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm

Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2

Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066486
BC-BR-12, NCT00003454
http://cancer.gov/clinicaltrials/BC-BR-12

Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003455
CDR0000066487, BC-BR-14
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066488
BRI-BT-7, NCT00003456
http://cancer.gov/clinicaltrials/BRI-BT-7
· Protocol BT-07, involving the study of Antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy

BT-07 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
2 / 8.3% – # and % of Patients Showing Complete Response
1 / 4.2% – # and % of Patients Showing Partial Response
3 / 12.5% – # and % of Patients Showing Stable Disease
18 / 75.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066489
BC-BT-9, NCT00003457
http://cancer.gov/clinicaltrials/BC-BT-9
· Protocol BT-09, involving the study of Antineoplastons A10 and AS2-1 in patients with brain tumors

BT-09 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
4 / 14.3% – # and % of Patients Showing Complete Response
5 / 17.9% – # and % of Patients Showing Partial Response
13 / 46.4% – # and % of Patients Showing Stable Disease
6 / 21.4% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066490
BC-BT-10, NCT00003458
http://cancer.gov/clinicaltrials/BC-BT-10
· Protocol BT-10, involving the study of Antineoplastons A10 and AS2-1 in children with brain tumors

BT-10 – Protocol #
30 – Patients Accrued
22 – Evaluable Patients
3 / 13.6% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
7 / 31.8% – # and % of Patients Showing Stable Disease
11 / 50.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066491
BC-BT-11, NCT00003459
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11, involving the study of Antineoplastons A10 and AS2-1 in patients with brainstem glioma

BT-11 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
5 / 17.9% – # and % of Patients Showing Complete Response
4 / 14.3% – # and % of Patients Showing Partial Response
12 / 42.9% – # and % of Patients Showing Stable Disease
7 / 25.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
· Protocol BT-12, involving the study of Antineoplastons A10 and AS2-1 in children with primitive neuroectodermal tumors (PNET)

BT-12 – Protocol #
13 – Patients Accrued
11 – Evaluable Patients
3 / 27.3% – # and % of Patients Showing Complete Response
1 / 9.1% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in children with low grade astrocytoma, a type of PMBT

BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066505
BC-BT-14, NCT00003469
http://cancer.gov/clinicaltrials/BC-BT-14

Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066507
BC-BT-15, NCT00003470
http://cancer.gov/clinicaltrials/BC-BT-15
· Protocol BT-15, involving the study of Antineoplastons A10 and AS2-1 in adult patients with anaplastic astrocytoma, a type of PMBT

BT-15 – Protocol #
27 – Patients Accrued
20 – Evaluable Patients
3 / 15.0% – # and % of Patients Showing Complete Response
2 / 10.0% – # and % of Patients Showing Partial Response
9 / 45.0% – # and % of Patients Showing Stable Disease
6 / 30.0% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066508
BC-BT-16, NCT00003471
http://cancer.gov/clinicaltrials/BC-BT-16

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Closed
Age 18 and over
Phase 2
Phase II
CLOSED
Protocol IDs
CDR0000066509
BC-BT-17, NCT00003472
http://cancer.gov/clinicaltrials/BC-BT-17

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066510
BC-BT-18, NCT00003473
http://cancer.gov/clinicaltrials/BC-BT-18
Protocol BT-18, involving a study of Antineoplastons A10 and AS2-1 in the treatment of “mixed glioma,” a type of PMBT

BT-18 – Protocol #
20 – Patients Accrued
13 – Evaluable Patients
3 / 23.1% – # and % of Patients Showing Complete Response
1 / 7.7% – # and % of Patients Showing Partial Response
3 / 23.1% – # and % of Patients Showing Stable Disease
6 / 46.2% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066511
BRI-BT-20, NCT00003474
http://cancer.gov/clinicaltrials/BRI-BT-20
· Protocol BT-20, involving the study of Antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme, which recurred after standard radiation and/or chemotherapy

BT-20 – Protocol #
40 – Patients Accrued
22 – Evaluable Patients
1 / 4.5% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
12/ 54.5% – # and % of Patients Showing Stable Disease
8 / 36.4% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066512
BC-BT-21, NCT00003475
http://cancer.gov/clinicaltrials/BC-BT-21
· Protocol BT-21, involving the study of Antineoplastons A10 and AS2-1 in adults with primary malignant brain tumors

BT-21 – Protocol #
40 – Patients Accrued
23 – Evaluable Patients
2 / 8.7% – # and % of Patients Showing Complete Response
2 / 8.7% – # and % of Patients Showing Partial Response
9 / 39.1% – # and % of Patients Showing Stable Disease
10 / 43.5% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II
Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066513
BC-BT-22, NCT00003476
http://cancer.gov/clinicaltrials/BC-BT-22
· Protocol BT-22, involving a study of Antineoplastons A10 and AS2-1 in children with primary malignant brain tumors

BT-22 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
1 / 4.2% – # and % of Patients Showing Complete Response
3 / 12.5% – # and % of Patients Showing Partial Response
9 / 37.5% – # and % of Patients Showing Stable Disease
11 / 45.8% – # and % of Patients Showing Progressive Disease

Antineoplaston Therapy in Treating Patients With Ependymoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066516
BC-BT-24, NCT00003479
http://cancer.gov/clinicaltrials/BC-BT-24

Antineoplaston Therapy in Treating Patients With Meningioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066521
BC-BT-28, NCT00003483
http://cancer.gov/clinicaltrials/BC-BT-28

Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer
Colorectal Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066523
BC-CO-2, NCT00003485
http://cancer.gov/clinicaltrials/BC-CO-2

Antineoplaston Therapy in Treating Patients With Colon Cancer
Stage IV Colon Cancer
Recurrent Colon Cancer
Adenocarcinoma of the Colon
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003486
CDR0000066524, BC-CO-3
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
Esophageal Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
NCT00003487
CDR0000066525, BC-ES-2
THIS STUDY HAS BEEN TERMINATED (Withdrawn due to slow enrollment)

Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Head and Neck Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 16 and over
Protocol IDs
CDR0000066527
BC-HN-2, NCT00003489
http://cancer.gov/clinicaltrials/BC-HN-2

Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Phase 2
Closed
Protocol IDs
CDR0000066530
BC-LA-3, NCT00003491
http://cancer.gov/clinicaltrials/BC-LA-3

Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066531
BC-LA-4, NCT00003492
http://cancer.gov/clinicaltrials/BC-LA-4

Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066533
BC-LA-5, NCT00003494
http://cancer.gov/clinicaltrials/BC-LA-5

Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Age 18 and over
CLOSED
Protocol IDs
CDR0000066534
BC-LA-6, NCT00003495
http://cancer.gov/clinicaltrials/BC-LA-6

Antineoplaston Therapy in Treating Patients With Recurrent or Extensive-Stage Small Cell Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066535
BC-LA-7, NCT00003496
http://cancer.gov/clinicaltrials/BC-LA-7

Antineoplaston Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Lung Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
Closed
Age 18 and over
Phase 2
CLOSED
Protocol IDs
CDR0000066536
BC-LA-10, NCT00003497
http://cancer.gov/clinicaltrials/BC-LA-10

Antineoplaston Therapy in Treating Patients With Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066537
BC-LY-3, NCT00003498
http://cancer.gov/clinicaltrials/BC-LY-3

Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066538
BC-LY-6, NCT00003499
http://cancer.gov/clinicaltrials/BC-LY-6

Antineoplaston Therapy in Treating Patients With Refractory or Recurrent Intermediate-Grade Stage II, Stage III, or Stage IV Non-Hodgkin’s Lymphoma
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066540
BC-LY-7, NCT00003500
http://cancer.gov/clinicaltrials/BC-LY-7

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin’s Lymphoma
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066541
BC-LY-8, NCT00003501
http://cancer.gov/clinicaltrials/BC-LY-8

Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003502
CDR0000066542, BC-LY-9
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapyuuhnp
Procedure: differentiation therapy
Phase 2
NCT00003505
CDR0000066545, BC-LY-12
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Malignant Mesothelioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
NCT00003508
CDR0000066551, BC-MA-2
THIS STUDY HAS BEEN TERMINATED (Withdrawn due to slow enrollment)

Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509
http://cancer.gov/clinicaltrials/BC-ME-2
COMPLETED

Antineoplaston Therapy in Treating Patients With Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066554
BC-MM-2, NCT00003511
http://cancer.gov/clinicaltrials/BC-MM-2

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066555
BC-MW-2, NCT00003512
http://cancer.gov/clinicaltrials/BC-MW-2

Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory
Neuroblastoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066556
BC-NB-2, NCT00003513
http://cancer.gov/clinicaltrials/BC-NB-2

Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
Merkel Cell Carcinoma
Islet Cell Carcinoma
Neuroendocrine Carcinoma
Pituitary Tumor
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003514
CDR0000066557, BC-NE-2
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
Sarcoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066558
BC-PN-2, NCT00003515
http://cancer.gov/clinicaltrials/BC-PN-2

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066559
BC-PR-5, NCT00003516
http://cancer.gov/clinicaltrials/BC-PR-5

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Adenocarcinoma of the Prostate
Stage III Prostate Cancer
Stage IV Prostate Cancer
Recurrent Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Drug: bicalutamide
Drug: flutamide
Drug: leuprolide acetate
Procedure: alternative product therapy
Procedure: antiandrogen therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Procedure: endocrine therapy
Procedure: hormone therapy
Phase 2
NCT00003517
CDR0000066560, BC-PR-6
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Kidney Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066564
BC-RN-2, NCT00003520
http://cancer.gov/clinicaltrials/BC-RN-2

Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
Sarcoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066565
BC-SA-2, NCT00003521
http://cancer.gov/clinicaltrials/BC-SA-2

Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine
Small Intestine Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066566
BC-SI-2, NCT00003522
http://cancer.gov/clinicaltrials/BC-SI-2

Antineoplaston Therapy in Treating Patients With Stomach Cancer
Gastric Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066568
BC-ST-2, NCT00003524
http://cancer.gov/clinicaltrials/BC-ST-2

Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva
Cervical Cancer
Vulvar Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066569
BC-UC-2, NCT00003525
http://cancer.gov/clinicaltrials/BC-UC-2

Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Carcinoma of Unknown Primary
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase
Phase II
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066570
BC-UP-2, NCT00003526
http://cancer.gov/clinicaltrials/BC-UP-2

Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Liver Cancer
Drug: antineoplaston A10
Phase 2
Phase II
CLOSED
Age 14 and over
Protocol IDs
CDR0000066577
BC-HE-2, NCT00003530
http://cancer.gov/clinicaltrials/BC-HE-2

Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
Pancreatic Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Protocol IDs
Age 18 and over
CDR0000066578
BC-PA-2, NCT00003531
http://cancer.gov/clinicaltrials/BC-PA-2

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer
Ovarian Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066579
BC-OV-2, NCT00003532
http://cancer.gov/clinicaltrials/BC-OV-2

Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066580
BC-PR-4, NCT00003533
http://cancer.gov/clinicaltrials/BC-PR-4

Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
Phase 2
Phase II
CLOSED
Age 18 and over
Protocol IDs
CDR0000066581
BC-PR-8, NCT00003534
http://cancer.gov/clinicaltrials/BC-PR-8

Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2
Phase II
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066582
BC-BT-6, NCT00003535
http://cancer.gov/clinicaltrials/BC-BT-6
· Protocol BT-06, involving the study of Antineoplastons A10 and AS2-1 in children with high grade glioma

BT-06 – Protocol #
19 – Patients Accrued
11 – Evaluable Patients
1 / 9.1 % – # and % of Patients Showing Complete Response
3 / 27.3% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease

Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Drug: antineoplaston A10
Drug: methotrexate
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: chemotherapy
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
Phase 2
NCT00003536
CDR0000066584, BC-BR-10
THIS STUDY HAS BEEN WITHDRAWN PRIOR TO ENROLLMENT

Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Recruiting
Phase 2
Phase II
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066585
BC-BT-8, NCT00003537
http://cancer.gov/clinicaltrials/BC-BT-8
· Protocol BT-08, involving the study of Antineoplastons A10 and AS2-1 in patients with anaplastic astrocytoma

BT-08 – Protocol #
19 – Patients Accrued
14- Evaluable Patients
4 / 28.6% – # and % of Patients Showing Complete Response
0 / 0.0% – # and % of Patients Showing Partial Response
6 / 42.9% – # and % of Patients Showing Stable Disease
4 / 28.6% – # and % of Patients Showing Progressive Disease

A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma
Optic Nerve Glioma
Drug: Temozolomide
Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
Phase 3
NOT YET RECRUITING
NCT01260103
BRI-BT-54

(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in children with visual pathway glioma)

BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease

2003
recurrent diffuse intrinsic brain stem glioma
Phase 2
phase II
antineoplaston A10 and AS2-1

6 months median duration of treatment

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from the start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003
Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004
incurable recurrent and progressive multicentric glioma
Phase 2
Phase II
antineoplaston A10 and AS2-1 (ANP)
9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

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

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

http://www.secinfo.com/d11MXs.p23hz.htm

8/31/2012 (10/15/2012)
Form 10-Q (Received 10/15/12 • Period 08/31/12)
“The Company believes Antineoplastons are useful in the treatment of human cancer and is currently conducting PHASE II CLINICAL TRIALS of Antineoplastons relating to the treatment of cancer”

11/30/2012 (1/14/2013)
40–Active/Not Recruiting/Closed
Form 10-Q (For the quarterly period ended November 30, 2012) (1/14/2013)
“The Company is currently conducting ONE FDA-approved CLINICAL TRIAL”
http://www.faqs.org/sec-filings/130114/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-Q

Clinical trial costs paid direct
2010 – $4,243,476
FDA clinical trial expenses paid directly by Burzynski
5/31/2010 – $1,230,650
2/28/2010 – $4,243,476
Clinical trial costs paid direct
2009 – $4,678,626
FDA clinical trial expenses paid directly by Burzynski
11/30/2009 – $3,040,367
8/31/2009 – $1,951,248
5/31/2009 – $934,293
2/28/2009 – $4,678,626
11/30/2008 – $3,605,450
8/31/2008 – $2,375,780
5/31/2008- $1,160,297
5/31/2007 – $964,090
5/31/2006 – $978,705
11/30/2005 – $3,070,881
11/30/2004 – $3,128,619
8/31/2002 – $1,741,950
5/31/2002 – $908,639
8/31/2001 – $2,320,149
5/31/2001 – $1,178,965
5/31/2000 – $902,027
5/31/1999 – $1,095,523
3/1/1996 – 2/28/1997 – $532,853 – increase
3/1/1996 – 2/28/1997 – 115.6% – increase mainly due to Company agreeing to pay 20% of cost of chemicals used in Phase II clinical trials conducted by Burzynski