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 a
Contact: Adam Holdsworth
The Investor Relations Group