Burzynski Research Institute, Inc. Announces Lifting of the FDA Partial Clinical Hold - Phase 3 Clinical Study Agreed Upon
HOUSTON, June 23, 2014 /PRNewswire/ -- The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (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 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.
About Burzynski Research Institute, Inc.
Burzynski Research Institute, Inc. (OTCBB:BZYR) 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.
Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. 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 an ability to use Antineoplastons A10 and AS2-1. Burzynski Research Institute, Inc. does not undertake to update any such forward-looking statements or to publicly announce developments or events relating to the matters described herein.
SOURCE Burzynski Research Institute, Inc.