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Antineoplastons-Burzynki Research Institute

Clinical Trials Information

8/20/07 Annie Appleseed Project received the following email from Randy Hinton:

On March 13, 2007, I recieved a e-mail from Doctor B descibing his meeting with the FDA to close out his Diffuse Intrinsic Brainstem Glioma Trial.The results were as follows;

1. 26 out of 110 children symptom free at 24 months.

2. 6 out of the 26 were symptom free at 5 years and presumed cured.

This is matched by no hospital anywhere and on June 22 the FDA verified this to me on the phone.

Randy Hinton

Ann's NOTE: Randy arranged for Dr. Burzynski's office to send us a copy of the letter that was sent to FDA authorizing them to share the results of the "Phase II clinical trials with Antineoplastons in Brain Stem Glioma and the Phase III clinical study design".

According to a letter dated May 2, 2007, Dr. Burzynski stated that "FDA recommended the submission of the final Phase III protocol for a Special Protocol Assessment (SPA)."

9/07/04

Burzynski Research Institute Receives Orphan Drug Designation for Antineoplastons A10 and AS2-1 for Treatment of Brain Stem Glioma

HOUSTON--(BUSINESS WIRE)--Sept. 7, 2004--Burzynski Research Institute (BRI) (OTCBB:BZYR) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its drug candidates Antineoplastons A10 and AS2-1 for the treatment of brain stem glioma.

The FDA's orphan drug program is intended to encourage research, development and approval of products for diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.

If Antineoplastons A10 and AS2-1 receive approval from the FDA, orphan drug designation will provide Antineoplastons A10 and AS2-1 with seven years of market exclusivity following such regulatory approval. The designation also enables BRI to apply for clinical research funding, tax credits on clinical research and development expenses, a potential waiver of user fees associated with filing the marketing application and assistance from the Office of Orphan Product Development (OOPD) in guiding the drug through the regulatory approval process.

"We are pleased to receive the FDA's orphan drug designation for Antineoplastons A10 and AS2-1, an important step toward bringing this treatment to market," said Luke E. Lawson, Ph.D., Director of Regulatory Affairs of BRI. "Therapeutic options for brain stem glioma patients are rather limited.

We are committed to accelerating, wherever possible, our efforts to help address the unmet medical need of these patients worldwide."

Burzynski Research Institute is a biopharmaceutical company committed to developing medicines for serious and life threatening diseases from genomics and naturally occurring compounds. Research and development efforts are focused on antineoplastons, autoimmune disease and HIV.

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. BRI cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Information contained in forward-looking statements is based on current expectations and is subject to change, and future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to BRI's ability to obtain regulatory approval for Antineoplastons A10 and AS2-1. Receiving orphan drug designation does not increase the likelihood of eventual regulatory approval for a product candidate. BRI does not undertake to update any such forward-looking statements or to publicly announce developments or events relating to the matters described herein.

March 2000 update

Dr. Stanislaw Burzynski has a clinic in Houston, TX. Currently there are trials underway (still recruiting patients) with many different types of cancers.

Click on the website below and see what is being offered. Usually pre-treatment with conventional therapies are a prerequisite to participate.

At the first International Congress on Alternative and Complementary Medicine, I met Dr. Burzysnki. His talk was very scientific and complex. At that time I did not understand much of it. Later I read about his work.

His first clinical trial began in 1995. Even as this trial began, he was arrested and indicted for allowing his product to be sent through the U.S.Mail. He was acquitted.

Antineoplastons are protein compounds composed of peptides and amino acid derivatives that occur naturally in the body. They were first isolated from human blood, then human urine-now synthetically made.

Since 1977, Dr. Burzynski has treated thousands of patients with advanced cancers of many types. He has many dedicated and grateful patients. Some of them testified in Congress about the value of his therapy (February 1998).

A Phase I clinical trial demonstrated 20% survival for five years on advanced prostate, bladder, primary malignant brain tumors. In 1990, he reported that a number of these original patients were still alive and free from cancer.

In 1984, NCI tested antineoplastons using a mouse leukemia model which Dr. Burzynski felt was inappropriate. This test failed. But in 1992, a statement came from NCI stating that antitumor responses had been shown in 7 patients with primary brain tumors whose cases they reviewed.

Trials are also underway in Japan,Poland and the Netherlands.

Burzynski Research Institute, 12000 Richmond, Suite 260, Houston, TX. 77082-2431 (713)597-0111 Fax 597-1166


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padInterview w/ Dr. Burzynski, 12/02
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LINK This telephone interview with Dr. Burzynski was held in December 2002. The purpose of the interview is to inform people about Dr. Burzynski’s cancer treatment, Antineoplastons. It will be circulated for free on the Internet. Gavin Phillips has no affiliations with Dr. Burzynski either personally or professionally.
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padCenterwatch
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A place to look up trials Search under antineoplastons
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padCancermed website
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Check out Buryzinki trials home page
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pad9/02 Update on Trials w/Antineoplastons
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Clinical Trial updates
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padOur Alexander
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LINK to site
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padMarch 16, 2004  Clinical Trial Results
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Receive from health advocate, Arnold G.
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padAntiumor Effect Antineoplaston AS2-1: Colon Ca
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Abstract #2976 AACR, 3/04
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padDr. Stanislaw R. Burzynski
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LINK to Ralph Moss on Cancer articles on Burzynski
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padPatient Perspective - Stage IV Breast Cancer
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Received via email, 7/23/04
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padSusan Zimmerman, artist, cancer survivor
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In praise of Burzysnki article by Life Extension Foundation
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padBurzynski Patient Group
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LINK
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padTargeted Therapy w/Antineoplastons - Gliomas
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Integrative Cancer Therapies, 3/06
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padBurzynski Yahoo Group
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LINK to listserv for pts and future patients
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padNational Cancer Institute on Antineoplastons
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LINK to discussion
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