Interim analysis of anti-cancer vaccine, BiovaxID, to be conducted
Jun 13, 2007 - 3:59:37 AM
Tampa, FL--June 13, 2007 -- Biovest International, Inc. (OTCBB: BVTI), a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) announces a milestone in its effort to gain accelerated conditional approval for BiovaxID. The independent Data Monitoring Committee (DMC) has requested an interim analysis of all primary and secondary endpoints. The DMC is the independent committee that is responsible for safety and efficacy reviews of the BiovaxID Phase 3 Clinical Trial. Further, the DMC has requested data lock to occur in September 2007 to facilitate this interim analysis.
Additionally, the DMC has informed the Company that, after its review of unblinded data for the BiovaxID Phase 3 Clinical Trial, there are no identifiable safety concerns related to this therapy. The company believes that BiovaxIDs strong safety record will be supportive of its planned application for accelerated conditional approval of BiovaxID.
BiovaxID is an anti-cancer vaccine that is in pivotal Phase 3 Clinical Trial for the indication of non-Hodgkins lymphoma (NHL). BiovaxID is a personalized, patient specific vaccine designed to stimulate the patients own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating NHL, BiovaxID is designed to kill only cancerous B-cells. The BiovaxID Phase 3 clinical trial is being conducted at fourteen oncology centers within the United States and nineteen centers in Russia.
The Chairman of the DMC, Dr. Gerry Messerschmidt, MD, FACP, stated, There are no identifiable safety concerns in the current BiovaxID Phase 3 pivotal Clinical Trial at this time in our data review. To facilitate Biovests regulatory agency discussions and petitions based on its announced decision to seek accelerated conditional approval of BiovaxID, the DMC has requested that the database be fully updated and appropriate analyses of all enrolled/randomized patients to-date be performed for DMC-only closed session review at the Committees next scheduled meeting in September 2007.
At that time, the independent committee will explore possible mechanisms of unblinded data review with regulatory agencies.
Dr Messerschmidt further stated, The DMC recommends continuation of the Trial with the following changes: that the CHOP-R induction chemotherapy arm (the current Standard of Care) remain open and active; the PACE therapy arm of the study be discontinued, with protocol- defined follow-up of all current PACE patients enrolled.Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by mid-2008. The DMC has agreed to serve as a liaison between the Company and the FDA and the EMEA. If conditionally approved by the target date of mid-June 2008, BiovaxID would be commercially available in early 2009.
Dr. Steven Arikian, Chairman and CEO of Biovest, stated that The Phase 2 efficacy and safety data, combined with the Phase 3 safety data, blinded disease progression data, and third-party published data, reinforce our confidence that this anti-cancer vaccine is effective and the risk-benefit of BiovaxID in defeating NHL will be proven. Our follow-up data, which was generated during the National Cancer Institute (NCI) Phase 2 Clinical Trial, is now 10 years mature and our initial Phase 3 Clinical Trial patients will be 7 years mature at the data lock scheduled for September of this year. We believe that our robust and lengthy follow-up data, which covers over 200 patients in the Phase 2 and Phase 3 Clinical Trials to date, will be helpful in supporting our application for accelerated conditional approval of BiovaxID.
Pursuant to the DMCs request, we plan to submit a comprehensive interim analysis to the DMC in September 2007. Dr. Arikian added that, We are pleased with the independent confirmation of BiovaxIDs overall safety profile in its ongoing Phase 3 Clinical Trial. We are committed to getting BiovaxID to NHL patients as soon as possible. The support being offered by the DMC in upcoming discussions with the FDA and EMEA is of the utmost importance in achieving this goal.
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