Breaking News: FDA Lifts Ban On Burzynski
JAMES COLQUHOUN
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.
Watch the full story of Burzynski on FMTV as the documentary takes you on a journey through the treacherous, yet victorious, 14-year fight both Dr. Burzynski and his patients have had to endure in order to obtain FDA-approved clinical trials of Antineoplastons.
James Colquhoun is the filmmaker behind Food Matters, Hungry For Change, and Transcendence Seasons 1 & 2 and founder of Food Matters and FMTV. Along with Laurentine ten Bosch, James founded the Food Matters community following the release of the 2008 documentary, giving people the tools (films, books, articles, and guided programs) to take charge of their own health. From here, FMTV was born! It was designed as a place where you can access vital information by watching all of your favorite inspiring documentaries, expert interviews, & recipe videos in one place, and in early 2020 FMTV found it's new home on Gaia.