CAM Conference4/10 From Rita Starr, Patient Advocate: An enterprising documentary maker Eric Merola has made a movie regarding Dr. Stanislaw Burzynski, the pioneering cancer doctor whose scientific discovery–Antineoplastons–has saved the lives of hundreds of terminal cancer patients over the past 30+ years. Now you can order the DVD directly from the movie site: http://www.burzynskimovie.com/
As many of you know, my mother Sarah is alive today because of Dr. Burzynski. While she was still on his treatment for non-Hodgkin’s lymphoma, Dr. B was indicted by the federal government. Up until that point, the FDA had been trying for years to put him out of business but was unable to do so.
Because of our patient group (See http://www.burznskipatientgroup.org/ for patients’ stories) and some good lawyers, Dr. B was acquitted in 1997. Even during the trial, he was treating patients in FDA-approved clinical trials. Dr. B continues to treat cancer patients in clinical trials with his Antineoplastons and also outside of clinical trials with innovative & individualized treatments.
(See his website for more info:: http://www.cancermed.com/)
Dr. B’s Antineoplastons recently received Orphan Drug Designation for certain deadly brain tumors, and he has been given a green light to start Phase 3 trials which can lead to approval of this breakthrough cancer therapy. In spite of the excellent results he often achieves against some of the deadliest cancers and FDA permission to start Phase 3 trials, Dr. B still faces an uphill battle to get Antineoplastons approved. The FDA and large pharmaceutical companies do not want Antineoplastons approved because they threaten the chemotherapy industry.
Please see this movie and tell everyone you know (especially those with cancer) about Dr. Burzynski: The Movie. The more people who learn about this maverick doctor and his treatment, the more likely Antineoplastons will one day be approved and available to the millions of cancer patients who could benefit from this treatment.
AIDS drugs were approved with pressure from the public. Sadly, cancer patients & their families often suffer alone and don’t realize they are part of a very large special interest group that could exert enough pressure on the government to force the approval of Antineoplastons.
This important documentary is playing now around the country at various film festivals to rave reviews. Go to the link below for more information that everyone should see.
If it doesnt come to your area, you can eventually buy it on DVD.
2/10/09 Check out the press release from Burzyinski’s work with liver and kidney cancers.
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 describing
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.
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).”
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
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.
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