Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”

[1] – 1995 (10/1995) – The National Cancer Institute (NCI) at the National Institutes of Health (NIH) issued its CancerNet “fact sheet”

The problem is that there were “factual issues” with the CancerNet “fact sheet”
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[0] – All Americans are “presumed to know the law:”

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”
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Below is how the “fact sheet” looked before and after the “fact sheet’s” “factual issues” were fixed
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BOLD = changes
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[1] – 10/1995 – CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health
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[2] – 5/20/2002 – CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services
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[1] – 10/1995 – National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth
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[2] – 5/20/2002 – Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas
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[1] – 10/1995 – Dr. Burzynski has used these compounds to treat patients with various cancers
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[2] – 5/20/2002 – Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers
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[1] – 10/1995 – In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility
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[2] – 5/20/2002 – In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston
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[1] – 10/1995 – For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons
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[2] – 5/20/2002 – The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI
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[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[A] – Gives the reader the impression that in his entire clinical experience he had only 7 patients who benefitted from antineoplaston treatment

[B] – He prepared not 7, but dozens of cases for the NCI reviewers

[C] – The reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

(averaging one case per hour)
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[1] – 10/1995 – This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski
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[2] – 5/20/2002 – This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”
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[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[D] – The patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

[E] – Michael Hawkins, M.D., leader of the site visit team, specifically complimented him on how complete and well-organized they were

[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“Seven patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed”
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[1] – 10/1995 – The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors
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[2] – 5/20/2002 – The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors
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[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI)
sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate”

[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[G] – The statement of the NCI scientists who actually reviewed patient records was quite different from the above

Their report stated:

“The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate

(minutes of Decision Network committee meeting)
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[1] – 10/1995 – The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski
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[1] – 10/1995 – Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski
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[2] – 5/20/2002 – Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski
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[1] – 10/1995 – These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center
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[2] – 5/20/2002 – These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health
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[1] – 10/1995 – However, accrual to these studies was very slow and only nine patients were enrolled
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[2] – 5/20/2002 – Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials
======================================
[1] – 10/1995 – On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner
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[2] – 5/20/2002 – Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion
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[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[H] – The only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

[I] – Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, states that

“The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred

[J] – The NCI never made any effort to “reach a consensus.”

[K] – It simply violated the written protocol we had agreed upon

[L] – Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases

[M] – When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it
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[1] – 10/1995 – Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons
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[2] – 5/20/2002 – Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons
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[1] – 10/1995 – It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
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REFERENCES:
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[1] – Date Last Modified 10/1995
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CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health

National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth

Dr. Burzynski has used these compounds to treat patients with various cancers

In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility

For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons

This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski

The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors

The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski

Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski

These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center

However, accrual to these studies was very slow and only nine patients were enrolled

On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner

Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons

It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
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[2] – This fact sheet was reviewed on 7/13/01

Editorial changes were made on 5/20/02
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CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services

Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas

Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers

In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston

The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI

This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”

The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors

Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski

These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health

Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials

Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion

A paper describing this research, “Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma,” appears in Mayo Clinic Proceedings 1999, 74:137–145

Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons

At present, the Burzynski Research Institute is conducting trials using antineoplastons for a variety of cancers
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[1] – Date Last Modified 10/1995
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20130919-152702.jpg
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[2] – This fact sheet was reviewed on 7/13/2001

Editorial changes were made on 5/20/2002
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20130919-174914.jpg
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[2]
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http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
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[3] – 10/27/1995 – Burzynski sent a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)
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https://stanislawrajmundburzynski.wordpress.com/2013/09/18/24-1995-10271995-burzynski-to-dr-richard-klausner-7-pgs/
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[0] – Title 18, Part I, Chapter 47, § 1001
——————————————————————
18 USC § 1001 – Statements or entries generally
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http://www.law.cornell.edu/uscode/text/18/1001
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[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network
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https://stanislawrajmundburzynski.wordpress.com/2013/09/17/5-1991-11151991-dr-michael-j-hawkins-to-decision-network/
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[G] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/17/6-1991-12291-nci-decision-network-report-on-antineoplastons/
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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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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.)

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, 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
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Michael A. Friedman, M.D., 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) 2 page letter to Burzynski

I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:

Date Report

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

I am enclosing a summary of the categories of data that are included in the reports you have received

These reports are the same ones that have been provided to us by the contractor during the conduct of the Antineoplaston studies

Both the format and frequency of these reports are routine for reporting data of ongoing NCI Phase II trials to the Cancer Therapy Evaluation Program staff

These are also the same types of reports that are provided to pharmaceutical companies when they are cosponsors of a study

We have no individual patient records in our possession in addition to the Theradex reports

As of the last report provided to you of 4/10/1995, prior to the studies being put on hold and subsequently closed, you were sent the same reports that were provided to CTEP staff and protocols T93-0078 and T93-0134

However, enclosed for your convenience is a recent print-out of the data that was prepared for our staff in a slightly different format

Once the routine quality control review of data entry has been completed, we will send you a final print-out
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1995 (9/19/1995) – Friedman to Burzynski [18]
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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, 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
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol
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Mario Sznol, M.D., Department of Health and Human Services, National Institutes of Health

Dear Dr. Sznol,

Your letter of 4/3/1995

(copy attached)

does not provide adequate justification for the changes in the protocol for

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced
Recurrent Astrocytomas.”

Let me make perfectly clear that, as the discoverer and developer of antineoplastons and the individual with nearly 20 years clinical experience using them, it is my professional opinion that the drugs will not produce substantial benefit in such advanced patients

The current protocol has had success only in patients who have tumors not exceeding 5 cm in diameter and who do not have multiple tumors or leptomeningeal or systemic metastases

As the Senior Investigator of NCI requested, patients should have Karnofsky Performance Status of not lower than 70%

(letter attached)

As I have repeatedly informed you, it is exactly because of the current protocol’s failure to benefit advanced patients that we developed new and more aggressive protocols for such advanced tumors, for example, provides antineoplaston A10 in doses 3 times greater than that specified in the protocol currently being used

In order to make such dosing possible, we are using a much higher concentration of A10 — 300mg/mL instead of 80mg/mL

The dosing schedule being used for such advanced tumors is also quite different

Instead of injections of each antineoplaston every 30 minutes, patients receive a much greater amount every 4 hours

Pg. 2

The acceptance of very advanced brain tumor patients to the current protocol would be highly unethical because there is no realistic chance they will have a meaningful response

The list attached to your letter of 4/3/1995 (enclosed), proves my observation that patients who had tumors substantially larger than 5 cm do not respond well under the current protocol

There were only 2 such patients, with the largest tumor diameter corresponding to 5.5 and. 6.5 cm

Both had less than 50% decrease in the size of their tumors

According to the existing protocol, patients should have more than a 50% decrease in tumor size to be classified as responders

Please bear in mind that the point of this trial is not to prove once again that this protocol does not work in patients with very large tumors, multifocal tumors, and low Karnofsky scores

We have already established this fact

Moreover, the informed consent form as currently written falsely implies that the discoverer of antineoplastons believes such advanced patients may benefit substantially from the current protocol

In fact, I have specifically informed you on several occasions that I do not believe advanced patients will obtain substantial benefit

Please be forewarned that you may face legal liability resulting from these unethical misrepresentations

We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995

Based on the limited information received from Theradex on the 1st 7 cases, we have reason to believe that the protocol has been violated in every case

5 cases have been accepted in violation of inclusion criteria

Due to interruptions in the treatment schedule and the time necessary to escalate the dosage, one of these patients received less than 3 weeks of full dose treatment

Such duration of treatment was not sufficient to show the effectiveness of the therapy

Finally, 2 additional patients were removed from the study and said to have progression of disease when in fact no progression was documented

One of these patients, #4369975, underwent tumor resection 3 weeks after discontinuation of the treatment with antineoplastons

Microscopic examination of the tumor specimen confirmed absence of viable tumor cells

It is clear that what was classified as tumor progression corresponded to extensive necrosis or tumor death

What I thought was especially inexcusable and unethical is that the 30 year old patient #196370, who clearly did not have progression of the tumor, was removed from the study against the criteria for removal listed in the protocol

This patients died a few months later
I strongly believe that if the patient had continued the treatment under the protocol, his life would have been saved

Attached to this letter, you will find a list of

Pg. 3

violations of the protocol

Based on these violations, it is clear that the current investigators are unable to conduct this study under the current protocol

I hereby request that:

1) The National Cancer Institute immediately terminate the current investigators and appoint mew investigators at different medical institutions acceptable to Burzynski Research Institute

2) Patient accrual must cease until such investigators and institutions are appointed

Until you appoint the new investigators, I will provide free treatment and medical care under my supervision as long as necessary to the patients currently being treated under the protocol

SRB/cf

Enclosure

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkly Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Daniel Eskinazi
Dr. Michael Friedman
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Mark Malkin
Ms. Mary McCabe
Dr. Ralph Moss
Dr. David Parkinson
Ms. Dorothy Tisevich
Mr. Frank Wiewel
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1995 (4/20/1995) – Burzynski to [14]
1995 (4/20/1995) – Burzynski to [15] (3 pgs.)
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
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[6] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, 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
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[6] – 1991 (12/2/91) – NCI Decision Network Report on Antineoplastons [5 pgs. – Pg. 11] guidelines of the NCI’s Decision Network
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Minutes of the Meeting of the NCI’s Decision Network Regarding Antineoplastons A10 and AS2-1 12/2/1991

Pg. 11 (2nd pg.)

B. Candidates for DN Stage IV
Antineoplastons A10 and AS2-1, NSCs 648539D and 620261/#2

The antineoplastons have been considered as unconventional manner of cancer treatment because there have been very few independent interpretable scientific data on their potential clinical efficacy

Based on a recent report of observed responses in brain cancer patients treated with antineoplastons at the Burzynski Research Institute (founded by Dr. S.R. Burzynski) in Houston, Texas, the Cancer Therapy Evaluation Program (CTEP) conducted a site visit to review a “best case” series of clinical responses to antineoplastons in the treatment of brain tumors at the Institute

This case series does not constitute a clinical trial; the cases were selected on the basis of positive response from many different studies of antineoplaston treatment at the Institute

The site visit team determined that antitumor activity was documented in this best case series and that the conduct of Phase II trials were indicated to determine the response rate

The antineoplastons were presented as DN Stage IV candidates for the conduct of Phase II trials in glioblastoma multiforme, anaplastic astrocytoma, pediatric brain tumors, and low-grade gliomas, to confirm the observation of brain tumors at the Burzynski Institute

It was proposed that the same treatment regimen as that used at the Institute would be used in the Phase II trials

A decision regarding subsequent trials (e.g., other tumors, additional Phase I development, Phase III trials in brain tumors) would be deferred until the results of these initial trials were known

If the antineoplastons are approved for Phase II study, Dr. Burzynski will provide supplies of the materials for the clinical trials to the NCI free of charge

Dr. Burzynski presented background on antineoplaston research

His research is based on the hypothesis that antineoplastons are components of a biochemical defense system against cancer

The antineoplastons are medium and small peptides and amino acid derivatives that form the defense against cancer by inducing differentiation in neoplastic cells
Initial study on antineoplastons was concentrated on isolation of peptides in blood and urine of healthy people

Pg. 12 (2nd pg.)

Two main groups of antineoplastons have been isolated

Pg. 13 (3rd pg.)
Pg. 14 (4th pg.)

Decision: Antineoplastons A10 (NSC 648539D) and AS2-1 (NSC 620261/#2) passed DN Stage IV

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1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 pgs.] [8]
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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, 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
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network
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Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI)

Re: Antineoplaston

[7 pgs. – 1 pg.]

To: Decision Network

Attached is a summary of a review of a best case series of antineoplastons in the treatment of brain tumors which was conducted by CTEP at the Burzynski Research Institute and some background information on antineoplastons A10 and AS2-1

7 patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed

It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate

At the DN meeting, Dr. Burzynski will present some brief background data on antineoplastons and Dr. Nicholas Patronas, a neuroradiologist from the Clinical Center who was on the site visit team, will review the radiologic findings for the committee

Antineoplastons are being proposed for DN IV (Phase II trials)

We feel the 1st step is to confirm the observations of Dr. Burzynski in brain tumors

Initially 3 or 4 Phase II trials would be conducted (one trial in each of the following diseases: glioblastoma multiforme, anaplastic astrocytoma, pediatric brain tumors and possibly low grade astrocytomas) using antineoplaston A10 and AS2-1 in exactly the same manner Dr. Burzynski gave them in the cases we reviewed

A decision regarding subsequent trials (e.g.–other tumors, additional Phase I development, Phase III trials in brain tumors, etc) would be deferred until the results of these initial trials were known

Dr. Burzynski is willing to provide sufficient antineoplaston A10 and AS2-1 for these studies

The only impact on DCT would be the IND filing and the use of our clinical trials resources

cc: Dr. Burzynski

20130920-143047.jpg
======================================

Burzynski (The SEC filings)

NET LOSS / NET (LOSS) / Net loss / Net (loss) / net loss / net losses / losses
8/31/2010 – $2,580,000 – 6 months ended
8/31/2010 – $(2,579,873) – 6 Months Ended
8/31/2010 – $1,205,000 – 3 months ended
8/31/2010 – $(1,204,550) – 3 Months Ended
5/31/2010 – $(1,375,323)
5/31/2010 – $1,375,000 – 3
months ended
2/28/2010 – $4,831,000 – year ended
2/28/2010 – $4,831,000 – fiscal year ended
2/28/2010 – $(4,830,610)
11/30/2009 – $(3,522,434)
11/30/2009 – $3,522,000 – 9 months ended
11/30/2009 – $1,209,000 – 3 months ended
11/30/2009 – $(1,208,930)
8/31/2009 – $2,314,000 – 6 months ended
8/31/2009 – $(2,313,502) – 6 Months Ended
8/31/2009 – $(1,194,255)
8/31/2009 – $(1,194,225) – 3 Months Ended
8/31/2009 – $1,194,000 – 3 months ended
5/31/2009 – $(1,119,277)
5/31/2009 – $1,119,000 – 3 months ended
2/28/2009 – $5,128,000 – year ended
2/28/2009 – $5,128,000 – fiscal year ended
2/28/2009 – $(5,127,729)
11/30/2008 – $3,915,000 – 9 months ended
11/30/2008 – $(3,914,731)
11/30/2008 – $(1,342,257)
11/30/2008 – $1,342,000 – 3 months ended
8/31/2008 – $(2,572,474)
8/31/2008 – $2,572,000 – 6 months ended
8/31/2008 – $(1,290,341)
8/31/2008 – $1,290,000 – 3 months ended
5/31/2008 – $(1,282,133)
5/31/2008 – $1,282,000 – 3 months ended
5/31/2007 – $(1,061,069)
5/31/2007 – $1,061,000 – 3 months ended
5/31/2006 – $(1,157,424)
5/31/2006 – $1,157,000 – 3 months ended
11/30/2005 – $(3,530,147)
11/30/2005 – $3,530,000 – 9 months ended
11/30/2005 – $1,039,000 – 3 months ended
11/30/2004 – $(3,666,261)
11/30/2004 – $3,666,000 – 9 months ended
11/30/2004 – $1,161,000 – 3 months ended
11/30/2002 – $3,201,000 – 9 months ended
11/30/2002 – $1,109,000 – 3 months ended
8/31/2002 – $2,093,000 – 6 months ended
8/31/2002 – $1,015,000 – 3 months ended
5/31/2002 – $(1,077,469)
5/31/2002 – $1,077,000 – 3 months ended
11/30/2001 – $3,952,000 – 9 months ended
11/30/2001 – $1,220,000 – 3 months ended
8/31/2001 – $2,733,000 – 6 months ended
8/31/2001 – $1,318,000 – 3 months ended
5/31/2001 – $1,415,000 – 3 months ended
5/31/2001 – $(1,414,934)
5/31/2000 – $(1,084,280)
5/31/2000 – $1,084,000 – 3 months ended
5/31/1999 – $(1,297,474)
5/31/1999 – $1,297,000 – 3 months ended
2/28/1997 – $541,825 – year ending
2/29/1996 – $50,499 – year ending

Operating loss before other income
2/28/2010 – (4,830,610) – Year Ended
2/28/2009 – (5,127,018) – Year Ended

8/31/2010 – $1,255,692 – Company had net operating loss carryforwards available to offset future income which may be carried forward and will expire if not used between 2012 and 2031 in varying amounts
5/31/2010 – $1,212,249 – net operating loss carryforwards available to offset future income which may be carried forward and will expire if not used between 2012 and 2031 in varying amounts
2/28/2010 – $1,188,847 – net operating loss carryforwards available to offset future income
8/31/2009 – $1,327,454 – net operating loss carryforwards available to offset future income which may be carried forward in varying amounts until 2030
5/31/2009 – $1,250,714 – net operating loss carryforwards available to offset future income which may be carried forward in varying amounts until 2030

Research and development costs
8/31/2010 – $2,421,000 – 6 months ended
Research and development
8/31/2010 – $2,420,725 – 6 Months Ended
Research and development
8/31/2010 – $1,122,339 – 3 Months Ended
Research and development costs
8/31/2010 – $1,122,000 – 3 months ended
8/31/2010 – $7,000 – other research and development costs
Research and development
5/31/2010 – $1,298,386
Research and development costs
5/31/2010 – $1,298,000 – 3 months ended
5/31/2010 – $6,000 – increase in other research and development costs
2/28/2010 – $4,480,000 – Total research and development costs for fiscal years ended
Research and development
2/28/2010 – $4,480,497
Research and development costs
2/28/2010 – $4,480,000 – fiscal year ended
2/28/2010 – $7,000 – decrease in other research and development costs
Research and development
11/30/2009 – $3,214,199 – 9 Months Ended
Research and development costs
11/30/2009 – $3,214,000 – 9 months ended
Research and development
11/30/2009 – $1,146,393 – 9 Months Ended
11/30/2009 – $1,146,000 – 3 months ended
11/30/2009 – $4,000 – other research and development costs
11/30/2009 – $3,000 – other research and development costs
Research and development costs
8/31/2009 – $2,068,000 – 6 months ended
Research and development
8/31/2009 – $2,067,807 – 6 Months Ended
Research and development costs
8/31/2009 – $1,076,000 – 3 months ended
Research and development
8/31/2009 – $1,075,784 – 3 Months Ended
8/31/2009 – $2,000 – other research and development costs
8/31/2009 – $1,000 – other research and development costs
Research and development
5/31/2009 – $992,023
Research and development costs
5/31/2009 – $992,000 – 3 months ended
5/31/2009 – $1,000 – other research and development costs
2/28/2009 – $4,894,255
2/28/2009 – $4,894,000 – fiscal year ended
2/28/2009 – $4,894,000 – Total research and development costs fiscal years ended
Research and development costs
11/30/2008 – $3,755,000 – 9 months ended
11/30/2008 – $3,754,621 – 9 Months Ended
11/30/2008 – $1,288,000 – 3 months ended
11/30/2008 – $1,287,762 – 9 Months Ended
Research and development costs
8/31/2008 – $2,467,000 – 6 months ended
Research and development
8/31/2008 – $2,466,859
Research and development
8/31/2008 – $1,254,049 – 3 Months Ended
Research and development costs
8/31/2008 – $1,254,000 – 3 months ended
Research and development costs
5/31/2008 – $1,213,000 – 3 months ended
Research and development
5/31/2008 – $1,212,810
5/31/2007 – $1,017,452
Research and development costs
5/31/2007 – $1,017,000 – 3 months ended
5/31/2007 – $2,000 – other research and development costs
Research and development costs
5/31/2006 – $1,101,112
5/31/2006 – $1,101,000 – 3 months ended
Research and development costs
11/30/2005 – $3,397,000 – 9 months ended
11/30/2005 – $1,059,000 – 3 months ended
11/30/2005 – $14,000 – other research and development costs
11/30/2005 – $7,000 – other research and development costs
Research and development costs
11/30/2004 – $3,469,000 – 9 months ended
11/30/2004 – $1,085,000 – 3 months ended
Research and development costs
11/30/2002 – $3,028,000 – 9 months ended
Research and development costs
11/30/2002 – $1,067,000 – 3 months ended
11/30/2002 – $6,000 – increase in other research and development costs
8/31/2002 – $1,961,000 – 6 months ended
8/31/2002 – $945,000 – 3 months ended
8/31/2002 – $4,000 – decrease in other research and development costs
8/31/2002 – $4,000 – which were partially offset by increase in other research and development costs
Research and development
5/31/2002 – $1,015,479
Research and development costs
5/31/2002 – $1,015,000 – 3 months ended
5/31/2002 – $10,000 – which were partially offset by increase in other research and development costs
5/31/2002 – $8,000 – increase in other research and development costs
Research and development costs
11/30/2001 – $3,695,000 – 9 months ended
Research and development costs
11/30/2001 – $1,165,000 – 3 months ended
8/31/2001 – $2,530,000 – 6 months ended
8/31/2001 – $1,234,000 – 3 months ended
Research and development
5/31/2001 – $1,296,310
5/31/2001 – $1,296,000 – 3 months ended
Research and development costs
5/31/2001 – $253,000 increase was due to increases in personnel cost
5/31/2001 – 24% increase was due to increases in personnel cost
5/31/2001 – $181,000 – increase
Research and development
5/31/2001 – $6,000 – increase
other research and development costs
5/31/2000 – $1,043,260
5/31/2000 – $1,043,000 – 3 months ended
5/31/2000 – $9,000 – 3 MONTHS ENDED – partially offset by increase in other research and development costs
other research and development costs
5/31/1999 – $1,247,320
5/31/1999 – $1,247,000 – 3 months ended
Total research and development expense
1997 – $993,947
1997 – $993,947 – for year ending
8/31/1997 – $364,000 – 6 months ended
Total research and development expense
1996 -$461,094
1996 – $461,094 – for year ending

net operating loss carryforwards expire as follows:
Year ending
2/28/
or
2/29/
2029 – Company minimum tax credit 2/28/2010
2028 – $722
2027 – $31,219
2026 – $47,083
2025 – $13,732
2024 – $59,706
2023 – $75,450
2022 – $19,315
2021 – $24,117
2020 – $49,976
2018 – $50,786
2017 – $511,871
2016 – $11,818
2013 – $261,184

1998 research and development plan calls for $700,000 development costs

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study

Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer

Annals of Oncology 2010;21:viii221
http://www.burzynskiclinic.com/images/stories/Publications/8774.pdf

http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558

11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets (May 27/09)
Positive results borne from PHASE II clinical study of ANTINEOPLASTON therapy (ANP therapy) in metastatic colon cancer following curative resection of liver mets

study performed in Japan

study consisted of 65 colon cancer patients who had undergone curative resection of liver mets and were randomized to one of following groups:

1. infusion of X

2. infusion of X plus IV ANP therapy

There was significant difference in overall survival between the 2 groups

5 year survival rate:
X plus ANP therapy arm – 63% vs.
X only arm – 32%

Recurrence rate differed for the 2 groups
34%
69%

Lead investigator claims ANP therapy may find application not only in treatment of brain tumors as reported previously, but also in more common colorectal cancer
http://finance.yahoo.com/news/Metastatic-Colon-Cancer-In-a-bw-15355368.html?.v=1

http://www.colorectal-cancer.ca/IMG/pdf/CCAC_Research_June_19_2009.pdf

ANTINEOPLASTON Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets

Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for Liver Metastases from Colorectal Cancer
http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

Publication date: May 17, 2010
Category: Colorectal cancer
Publisher: ESMO
Y. Ogata; K. Shirouzu; K. Matono; M. Ushijima; S. Uchida; H. Tsuda
http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558

Abstract: 3558
Congress: ESMO 2010
Type: Publication
Topic: Colorectal cancer
Authors: Y. Ogata, K. Shirouzu, K. Matono, M. Ushijima, S. Uchida, H. Tsuda; Kurume/JP
http://www.biomeddefine.com/sdx/t31/all/100/epithelial+neoplasm+glandular+piperidines+chemical+ingredient.html

http://www.biomeddefine.com/sdx/t31/all/100/ca+secondary+cancer+piperidines+chemical+ingredient.html

Antineoplaston Therapy Doubles Five-Year Survival Rate Following Curative Resection of Hepatic Mets

Metastatic Colon Cancer:

In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled the 5-Year Survival Rate Following Curative Resection of Hepatic Metastases
http://www.drugs.com/clinical_trials/metastatic-colon-cancer-randomized-phase-ii-clinical-study-antineoplaston-therapy-doubled-5-year-7307.html

HOUSTON–(BUSINESS WIRE)–May 27, 2009 – The Burzynski Research Institute, Inc.

(BRI) is pleased to announce the results of a RANDOMIZED Phase II clinical study of ANTINEOPLASTON therapy (ANP therapy) in metastatic colon cancer following curative resection of hepatic metastases

study was performed at Kurume University School of Medicine (Japan) Department of Surgery

A report of the study results is currently in press
http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

http://abstracts.webges.com/viewing/view.php?congress=esmo2010&congress_id=296&publication_id=3558

3 – 4/2003 – ANTINEOPLASTON AS2-1 – Japan
http://www.ncbi.nlm.nih.gov/m/pubmed/12579278
The preventive effect of ANTINEOPLASTON AS2-1 on HCC recurrence

We designed a PHASE II clinical trail to clarify whether ANTINEOPLASTON AS2-1 … prolongs the recurrence-free interval of HCC patients who undergo frequent treatments for recurrence

10 patients enrolled in trial

2 in stage I
6 in stage II
1 in stage III
1 in stage IV-B

10 patients experienced 35 recurrence-free intervals

Recurrence-free intervals during ANTINEOPLASTON AS2-1 administration were significantly longer than those without ANTINEOPLASTON AS2-1 …

Patients who experienced recurrence-free intervals with and without ANTINEOPLASTON AS2-1 showed longer intervals during ANTINEOPLASTON AS2-1 administration than those before and after ANTINEOPLASTON AS2-1 administration …

2 patients in stage I showed longer recurrence-free intervals than those in more advanced stages

… ANTINEOPLASTON AS2-1 … prolonged the recurrence-free interval between regional treatments and improved survival rate of these patients

Tsuda H, Sata M, Kumabe T, Uchida M, Hara H

Department of Anesthesiology, Kurume Daiichi Social Insurance Hospital, Kushihara Kurumeshi, Fukuoka, Japan

Oncol Rep. 2003 Mar-Apr;10(2):391-7
http://www.spandidos-publications.com/or/10/2/391

http://www.burzynskiclinic.com/images/stories/Publications/964.pdf
References:

3. 1976 – BURZYNSKI – ANTINEOPLASTONS
BURZYNSKI SR
ANTINEOPLASTONS;
Biochemical defense against cancer
Physiol Chem Phys 8: 275-279, 1976

4. 1996 – ANTINEOPLASTON A10 and AS2-1 – Japan
Tsuda H, Hara H, Eriguchi N, et al
Toxicology study on ANTINEOPLASTON A10 and AS2-1 in cancer patients
Kurume Med J 42: 241-246, 1996

12. 1987 – BURZYNSKI – ANTINEOPLASTON A10
Hendry LB, Muldoon TG, BURZYNSKI SR, et al
Stereochemical modelling studies of the interaction of ANTINEOPLASTON A10 with DNA
Drugs Exp Clin Res 1: 77-81, 1987

14. 1992 – SAMID (learned from BURZYNSKI)
Samid D, Shack S, and Sherman LT
Phenylacetate:
A novel nontoxic inducer of tumor cell differentiation
Cancer Res 52: 1988-1992, 1992

15. 1989 – BURZYNSKI

16. 1992 – ANTINEOPLASTON A10 – Japan

17. 1996 – ANTINEOPLASTON A10 and AS2-1 – Japan
Tsuda H, Iemura A, Sata M, et al
Inhibitory effect of ANTINEOPLASTON A10 and AS2-1 on human hepatocellular carcinoma cells
Kurume Med J 43: 137-47, 1996

19. 1998 – ANTINEOPLASTONS – Japan

20. 2002 – Japan

PUBLICATIONS BY S.R. BURZYNSKI AND ASSOCIATES (NOT INCLUDING PUBLICATIONS BEFORE 2002)
http://www.burzynskiclinic.com/scientific-publications.html

1996 – ANTINEOPLASTON A10 and AS2-1 – Japan
http://www.ncbi.nlm.nih.gov/m/PubMed/8755117
Inhibitory effect of ANTINEOPLASTON A10 and AS2-1 on human hepatocellular carcinoma cells

ANTINEOPLASTONS, first described by Burzynski …

ANTINEOPLASTON A10 is the first chemically identified ANTINEOPLASTONS

These metabolites are water soluble and have ANTITUMOR effect …

The mixture of phenylacetylglutamine and phenylacetic acid in the ratio of 1 to 4 was also shown to have ANTITUMOR effect in tissue culture study, then formulated as ANTINEOPLASTON AS2-1

The reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for the treatment of human hepatocellular carcinoma since this tumor recurs frequently despite initial successful treatment

Tsuda H, Iemura A, Sata M, Uchida M, Yamana K, Hara H.

Kurume University School of Medicine, Japan

1) Departments of Anesthesiology
2) Departments of Pathology
3) Departments of Medicine
4) Departments of Radiology
5) Departments of Surgery

Released 2009/08/11

Kurume Med J. 1996;43(2):137-47

The Kurume Medical Journal
https://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article
PDF:
https://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_pdf
References:
https://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article/references
1. 1976 – BURZYNSKI – ANTINEOPLASTON
BURZYNSKI SR
ANTINEOPLASTON;
Biochemical defense against cancer
Physiol Chem Phys 1976; 8:275-279

2. 1985 – BURZYNSKI – ANTINEOPLASTON A10
BURZYNSKI SR, and Hai TT
ANTINEOPLASTON A10
Drugs of the Future 1985; 10:103-105

3. 1986 – BURZYNSKI – ANTINEOPLASTON AS2-1 and AS2-5
BURZYNSKI SR, Mohabbat MO, and Lee SS
Preclinical studies of ANTINEOPLASTON AS2-1 and ANTINEOPLASTON AS2-5
Drugs Exp Clin Res 1986 (Suppl); 1:25-28

4. 1988 – JAPAN – ANTINEOPLASTON A10
Eriguchi N, Hara H, Yoshida H, Nishida H, Nakayama T et al.
Chemopreventive effect of ANTINEOPLASTON A10 on Urethane-induced pulmonary neoplasia in mice
J Jpn Soc Cancer Ther 1988; 23 (7):1560-1565

5. 1987 – BURZYNSKI – ANTINEOPLASTON A10
Hendry LB, Muldoon TG, BURZYNSKI SR, Copland JA, and Lerner AF
Stereochemical modelling studies of the interaction of ANTINEOPLASTON A10 with DNA
Drugs Exp Clin Res 1987 (Suppl); 1:77-81

7. 1986 – BURZYNSKI
Liau MC, and BURZYNSKI SR
Altered methylation complex isozymes as selective targets for cancer chemotherapy
Drugs Exp Clin Res 1986 (Suppl); 1:77-86

8. 1988 – see 5. – ANTINEOPLASTON A10
Muldoon TG, Copland JA, and Hendry LB
Actions of ANTINEOPLASTON A10 on the genesis and maintenance of specific subpopulations of rodent mammary tumor cells
Advances in Experimental and Clinical Chemotherapy 1988; 1:15-18

10. 1991 – JAPAN – ANTINEOPLASTON A10
Nishida H, Yoshida H, Eriguchi N, Hoshino K, Kubota H et al.
Inhibitory effect of orally administered ANTINEOPLASTON A10 on the growth curve of human breast cancer transplanted to athymic mice
J Jpn Soc Cancer Ther 1991; 26:596-601

12. 1991 – SAMID (learned from BURZYNSKI)
Samid D, Yeh T-J and Shack S
Interferon in combination with antitumorigenic phenylderivatives; potentiation of INF alpha activity in vitro
Br J Haematol 1991; 79 (Suppl) 1:81-83

13. 1992 – SAMID (learned from BURZYNSKI)
Samid D, Shack S, and Sherman LT
Phenylacetate:
A novel nontoxic inducer of tumor cell differentiation
Cancer Research 1992; 52:1988-1992
http://europepmc.org/abstract/MED/8755117/reload=0;jsessionid=MhBwMcen2a7a9AibBaLc.2