Biovest plans Canadian submission for personalized cancer vax
Biovest has chosen Canada for the first submission for approval of its personalized cancer vaccine, BiovaxID. The vaccine, created to treat follicular non-Hodgkin lymphoma, specifically targets the malignant B cells causing the disease, and could become the first cancer vaccine marketed for lymphoma patients.
The BiovaxID cancer vaccine is based on proteins from the patients' own cancerous B cells, along with KLH and GM-CSF to trigger the immune system. In Phase III trials, the vaccine increased disease-free survival by 14 months.
Biovest's president and 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."
BiovaxID could also have potential in other B cell cancers, including mantle cell lymphoma (for which it has orphan drug status in Europe), chronic lymphocytic leukemia and multiple myeloma.
- read the press release
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