BRI reports positive results from Phase II glioma trial

Fri. May 08, 2009; Posted: 09:07 AM

May 08, 2009 (Datamonitor via COMTEX) -- BZYR | Quote | Chart | News | PowerRating -- Burzynski Research Institute, a US-based biopharmaceutical company, has reported positive safety and efficacy results in its Phase II clinical trial of antineoplaston A10 and antineoplaston AS2-1 therapy, or ANP therapy, in children with optic pathway glioma.

Based on preliminary responses and additional comments from the FDA, a protocol for a Phase III randomized trial with ANP in optic pathway glioma (OPG) will be prepared and submitted for FDA special protocol assessment to secure agreement on the design of a Phase III trial to serve as an efficacy claim in a new drug application.

According to Burzynski Research Institute (BRI), results from the Phase II study of ANP therapy suggest that this form of treatment is a very good alternative to chemotherapy.

Based on the treatment of 16 patients, complete and partial responses were documented in five patients, stabilization of disease in six patients, and progressive disease in only one patient. ANP therapy was associated only with grade 1 and grade 2 toxicities in some patients. There were no grade 3 or 4 or chronic adverse events, the company said.

Stanislaw Burzynski, chairman and CEO of BRI, said: "Children diagnosed with OPG are in need of therapies that can provide long-term responses and minimal toxicities. The results of the ANP trial in OPG demonstrate the potential role of ANP as a novel treatment option for this type of brain tumor. We are very encouraged by the outcome of our discussion with the FDA."

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