Burzynski Research Institute Announces Positive Results of Phase II ANP Clinical Trial
5/6/2009 8:41:24 AM
HOUSTON--(BUSINESS WIRE)--The Burzynski Research Institute (BRI) announced today positive safety and efficacy results in its Phase II clinical trial of Antineoplaston A10 and Antineoplaston AS2-1 therapy (ANP therapy) in children with optic pathway glioma (OPG). The results were presented to the FDA in the Request for End of Phase II Meeting Briefing Package (ANP in OPG), to be discussed at a meeting with the FDA on May 7, 2009. The FDA responded to the questions in the Briefing Package and issued additional comments before the meeting. The answers and comments were clear, and the meeting was cancelled since further discussion was not required. Based on preliminary responses and additional comments from the FDA, a protocol for a Phase III randomized trial with ANP in OPG will be prepared and submitted for FDA Special Protocol Assessment (SPA) to secure agreement on the design of a Phase III trial to serve as an efficacy claim in a New Drug Application (NDA).
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