Biovest targets mantle cell lymphoma as next indication for BiovaxID

Jun 22 2010

Biovest International, Inc. (Other OTC:BVTI) today announced at the Active Immunotherapeutics Forum in Barcelona, Spain, that the Company is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication for its personalized cancer vaccine, BiovaxID®. At the conference, the Company reviewed positive data from an open label Phase II mantle cell lymphoma clinical trial and reported plans to meet with the FDA later this year to discuss a pathway to seek regulatory approval for this hematological indication for which there is no current consensus standard-of-care. Biovest is also currently preparing to seek approvals for BiovaxID for the treatment of follicular non-Hodgkin's lymphoma.

According to Biovest's Vice President, Product Development & Regulatory Affairs, Dr. Carlos F. Santos, "There is an urgent unmet need for new and safe treatment options targeting this incurable, aggressive type of non-Hodgkin's lymphoma, as mantle cell patients are currently limited to few treatment options, often consisting of autologous stem cell transplants or aggressive immunochemotherapies which have significant toxicity and mortality risks. Based on encouraging Phase II data for BiovaxID in the treatment of mantle cell lymphoma, we plan to meet with the FDA to discuss a strategy to seek regulatory approval in the most expedited manner possible. In this study, we observed a tumor-specific immune response in 20 of 23 patients vaccinated with BiovaxID, and consistent with all of our other studies, the vaccine was very well tolerated and safe. As these results were obtained following a rituximab-containing chemotherapy (EPOCH-R), the cellular and humoral responses observed suggest that BiovaxID can augment benefits obtained with a rituximab-containing chemotherapy induction regimen."

Biovest recently filed an application with the FDA seeking Orphan Drug status for BiovaxID for the mantle cell lymphoma indication. This aggressive form of lymphoma constitutes about 6% of all non-Hodgkin's lymphoma cases or approximately 7,800 cases per year in the U.S. and Europe combined.

Dr. Santos also reported that, "The median overall survival for mantle cell lymphoma is approximately 36-months, and our Phase II study showed an 89% overall survival rate at a median follow-up of 46-months