Biovest wants accelerated approval for anti-cancer vax
Accentia Biopharmaceuticals' subsidiary Biovest International today announced positive results from its Phase 3 Fast-Tracked clinical trial of BiovaxID for the treatment of indolent follicular non-Hodgkin's lymphoma. The trials were halted in June upon analyses by the data monitoring board that revealed a significant survival rate for BiovaxID patients, versus the control arm. According to study data, at 36 months, 61 percent of BiovaxID patients were cancer-free, while only 37 percent of control patients were.
Rather than follow patients in both trial arms, Biovest will now petition for approval to offer all study participants treatment with the drug after analyses demonstrated that the vaccine prolongs cancer-free survival by 44 percent (nearly 14 months). "We believe that these strongly positive clinical results make it unethical to continue the trial as originally designed," said Biovest's Chairman and CEO, Dr. Steven Arikian. "In particular, we believe that we should offer BiovaxID to patients in the control arm who have not relapsed yet, and to patients in both arms who have relapsed but who can achieve another complete remission."
Biovest will seek Accelerated Approval from the FDA, and intends to apply for approval in Europe, Asia and Australia.
- read the Biovest release