Dr. Stanislaw Burzynski won the largest, and possibly the most convoluted and intriguing legal battle against the Food & Drug Administration in American history.
His victorious battles with the United States government were centered around Dr. Burzynski's gene-targeted cancer medicines he discovered in the 1970's called Antineoplastons, which have currently completed Phase II FDA-supervised clinical trials in 2009. The FDA proceeded to place a hold on any further trials, until now…
The Burzynski Research Institute, Inc. announced that the FDA has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.
The FDA's decision to lift the clinical hold marks on an important step in the development of Antineoplastons for the treatment of various forms of brain tumors in the US. At the same time, the Company is evaluating possible next steps for the Antineoplastons clinical program given the current progress and anticipated resource requirements of the ongoing program.
Burzynski Research Institute, Inc. is a biopharmaceutical company committed to developing treatment for cancer based on genomic and epigenomic principles. Research and development efforts are focused on basic research and phase 3 clinical trials, particularly in the treatment of brain tumors and other forms of cancer.
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