Biovest seeking market approval for lymphoma vaccine in Canada


Biovest International, the maker of the as-yet-unapproved BiovaxID, a personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, is announcing that it will pursue market approval for the vaccine in Canada as early as this year.

Biovest intends to file a New Drug Submission (NDS) later in 2012 with Health Canada, that country's drug approval agency. If approved by Health Canada, BiovaxID would represent the world’s first cancer vaccine available for lymphoma.

Biovest made the decision to pursue approval after meeting with Health Canada's Biologics and Genetic Therapies Directorate (BGTD). In that meeting, Biovest presented the results of three separate clinical trials conducted over a decade in conjunction with the United States' National Cancer Institute. Two trials were Phase II and the third, a controlled, randomized, double-blinded, multi-center Phase III clinical trial.

Said Carlos F. Santos, Ph.D., Biovest’s Senior Vice President of Product Development & Regulatory Affairs:

"Our meeting with Canada’s BGTD confirms the comprehensive and robust nature of our clinical data including data from three long-running clinical trials ... 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."

Source: Biovest

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