Biovest strong Ph III data for BiovaxID

USA-based Biovest International is seeking to make its personalized cancer vaccine, BiovaxID, available to all patients in a late-stage follicular non-Hodgkin's lymphoma trial after the unblinded data showed strong efficacy.

The intent-to-treat analysis from the point of randomization for all patients in the Phase III trial showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months, which is clinically and statistically significant compared to the control group, that saw a median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p=0.045) with a median follow up of 56.6 months (range 12.6 to 89.3 months).

The company, which is a wholly-owned unit of Accentia Biopharmaceuticals, has committed to provide the Food and Drug Administration with a detailed report based on this end-of-study data, including statistical analysis, prior to their next meeting in order to discuss a petition to treat all patients in the clinical trial with BiovaxID and to seek accelerated of the vaccine approval under sub-part E.