FDA Gives Permission To Use Very Sensitive Molecular Evidence Of Cancer In BiovaxID Pivotal Phase 3: Company Intends To Use Blood Test To File Application For Accelerated Approval
5/16/2006 12:53:14 PM
WORCESTER, Mass.--(BUSINESS WIRE)--May 16, 2006--Biovest International, Inc. (OTCBB: BVTI - News) has been notified by the United States Food and Drug Administration (FDA) that its proposal to utilize molecular remissions data as a new secondary endpoint in its ongoing clinical trial is acceptable to the agency. Biovest is conducting a pivotal Phase 3 trial evaluating BiovaxID(TM), the Company's personalized, targeted anti-cancer immunotherapy for treatment of follicular non-Hodgkin's lymphoma at over 20 major medical centers throughout the U.S. Biovest previously reported positive Phase 2 results for BiovaxID - more than 9 years after treatment 95% of BiovaxID treated patients are still alive. Approximately 70 % of evaluable patients showed no evidence of tumor cells when measured using highly precise molecular remissions data.
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