Biovest International Inc.(fka BVTIQ)

[surf1944]

7:23AM Biovest conducts end of Phase III Review with FDA of BiovaxID as consolidation therapy in Non-Hodgkin's Lymphoma (BVTI) 0.41 : Co identifies potential biomarker associated with significant increase in duration of cancer-free survival in vaccinated patients compared to matched controls. In the upcoming meeting with the FDA regarding the design of the confirmatory registration study, Biovest anticipates exploring the use of a specific subtype of the idiotype biomarker found in a retrospective analysis of the first Phase III clinical trial, BV301. In Biovest's analysis of the first Phase III trial, the Company identified the IgM subtype showing an 84% improvement in duration of first complete remission in patients with this biomarker who received vaccine compared to matched IgM isotype control vaccinated subjects (median of 52.9 months in vaccinated patients vs 28.7 in matched controls; adj. p=0.001). Concurrent with FDA's registration activities, Biovest will continue to advance seeking marketing approvals for BiovaxID in the European Union (EU) and Canada with those planned applications supported by evidence of clinical benefit from the three human clinical trials conducted to date in collaboration with the U.S. National Cancer Institute (NCI).