The Burzynski Research Institute Inc. (BRI) announced 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.
Date: June 23, 2014
Source: Burzynski Research Institute