Biovest International, Inc., an emerging leader in the field of active personalized immunotherapies and a subsidiary of Accentia Biopharmaceuticals, Inc., is seeking marketing approval in Canada for BiovaxID, its personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system.

Biovest plans to file a New Drug Submission (NDS) later this year with Health Canada, the Agency responsible for approving drugs in Canada. If approved, BiovaxID would represent the world’s first cancer vaccine available for lymphoma patients.

BiovaxID is an autologous active immunotherapy (personalized cancer vaccine) for the treatment of certain B-cell subtypes of non-Hodgkin's lymphoma, an incurable form of blood cancer. Over the past decade, two phase II clinical trials and a phase III clinical trial have demonstrated strong and cumulative evidence with regards to BiovaxID’s safety and efficacy. With regards to safety, all clinical trials to date demonstrate that BiovaxID vaccination is highly safe and poses a nearly vanishingly small toxicity risk relative to approved anti-lymphoma agents. Moreover, BiovaxID provides substantial and durable clinical efficacy with the phase III clinical trial demonstrating that BiovaxID significantly improves disease-free survival in follicular lymphoma and the phase II mantle cell lymphoma clinical trial demonstrating that BiovaxID induces strong idiotype-specific T-cell responses which strongly correlate with highly-statistically significant overall survival.

Biovest based its decision to pursue Canadian marketing approval following a formal pre-filing advisory meeting with Health Canada's Biologics and Genetic Therapies Directorate (BGTD). The meeting with the BGTD included a comprehensive presentation of the three BiovaxID clinical trials conducted as part of a nearly decade-long collaboration with the U.S. National Cancer Institute (NCI). The data review included long-term outcomes from two phase II clinical studies and a controlled, randomized, double-blinded, multi-centre phase III clinical trial. In addition to company representatives, the BGTD received presentations from two key lymphoma opinion leaders, Larry W. Kwak, M.D., Ph.D., chairman of the Department of Lymphoma/Myeloma and Associate Director of the Center for Cancer Immunology Research at the University of Texas MD Anderson Cancer Center and Neil L. Berinstein, M.D., Professor of Medicine, University of Toronto and Director of Translational Research, Ontario Institute for Cancer Research.

Carlos F. Santos, Ph.D., Biovest’s senior vice president, product development & regulatory affairs stated, “Our meeting with Canada’s BGTD confirms the comprehensive and robust nature of our clinical data including data from three long-running clinical trials. Importantly, our studies provide a substantial body of evidence of vaccine safety and efficacy, including the first randomized vaccine trial to show benefit in lymphoma and demonstrate that BiovaxID provides patients with an effective and highly-safe vaccination option to complement current treatment options. At the meeting, the BGTD supported the filing of an NDS with Health Canada seeking marketing approval for BiovaxID, thus validating more than 15-years of committed, diligent work conducted by Biovest and the NCI. Accordingly, we continue to move forward with preparations for the future product launch and commercialization assuming we obtain an approval decision for the Canadian market.”

According to M.D. Anderson’s Dr. Kwak, “An urgent need exists for improved post-chemotherapy consolidation therapies for patients with follicular lymphoma. While combination rituximab-chemotherapy regimens available today often induce tumour remissions in the early stages of treatment, these remissions seldom last; most patients relapse within years after discontinuing treatment. Moreover, upon relapse, the eventual development of resistant disease means this disease remains incurable. With BiovaxID, we hope to offer patients a non-immunosuppressive vaccine to consolidate the benefits achievable with modern induction therapy, and in doing so spare them the toxicities and relapses common to lymphoma today.” In 2010, Dr. Kwak was the first active MD Anderson faculty member to be named to TIME Magazine’s “TIME 100” annual list of the 100 most influential people in the world for his contributions to the advancement of cancer vaccines.

Dr. Berinstein, who formerly led the development of cancer vaccines at Sanofi Pasteur, commented on how BiovaxID might be perceived if approved in Canada, “When patients are diagnosed with lymphoma, by definition, their malignant cells have ‘escaped’ the immune system, but by creating a customized vaccine using a target protein exclusively expressed on the cancerous cells, we can add another powerful agent to existing treatment regimens. I’m impressed with the BiovaxID study results to date, and I believe Canadian patients and physicians will embrace a highly safe and effective personalized vaccine approach that recruits the patient’s own immune system to engage in the fight against lymphoma.”

The decision to proceed with an NDS filing in Canada is a significant step in Biovest’s worldwide regulatory strategy. Following the positive meeting result in Canada, Biovest is in the process of conducting other clinical pre-filing meetings in various jurisdictions including with European authorities, the U.S. FDA and potentially other countries as part of the Company’s global commercialization plan for BiovaxID.

Biovest’s president & CEO, Samuel S. Duffey, added, “It is 100% certain that Biovest will seek marketing approval in Canada, which represents a significant potential market opportunity for BiovaxID. Based on the feedback from Health Canada, we have confidence in our ongoing worldwide regulatory strategy to seek marketing approvals in multiple countries, supported by a compelling body of evidence demonstrating the safety and efficacy of BiovaxID.”