Biovest International, Inc. Conducts End of Phase III Review With FDA of BiovaxID™ as Consolidation Therapy in Non-Hodgkin's Lymphoma
8/14/2012 9:03:40 AM
TAMPA, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that it conducted a formal clinical guidance meeting with the U.S. FDA to determine the most expeditious U.S. registration pathway for BiovaxID™, its personalized cancer vaccine for the consolidation treatment of follicular non-Hodgkin’s lymphoma. During the FDA meeting, Biovest reviewed the unmet need in the U.S. where an estimated 50% of follicular lymphoma patients achieving first remission do not receive any treatment even though their cancer is at near-universal risk of relapse. A primary contributing factor to this urgent medical need for additional consolidation agents is the immunosuppressive nature of all approved consolidation agents, which target the same antigen, CD20, used as part of induction therapy. This includes rituximab which when used as a consolidation agent (rituximab maintenance) is generally administered on a bi-monthly dosing schedule over several years resulting in immunosuppression that is significantly prolonged as compared to the use of rituximab as an agent in first line chemo induction therapy or following disease progression. At the meeting, the FDA required that Biovest conduct a second Phase III clinical trial to confirm the clinical data generated in the Phase III trial BV301 and complete the Company’s BiovaxID development program to support the filing of a Biologics License Application (BLA). Further, FDA offered to work out with Biovest a registration trial design for such a confirmatory Phase III study. The Company intends to accept this FDA offer to meet within the next several months to advance the clinical development of BiovaxID to discuss a trial protocol that can most expeditiously generate registration data using agreed upon endpoints.