Published on June 29, 2007 at 5:21 AM
Biovest International announced on June 27, 2007 blinded interim data from the start of its fast-tracked pivotal Phase 3 clinical trial of BiovaxID for Non-Hodgkin's lymphoma (NHL) from September 2000 through June 2006.
This interim blinded data is the most recent data that has been made available to the Company prior to its latest meeting with the Data Monitoring Committee for the ongoing Phase 3 study. The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine. Randomization was 2:1 in favor of BiovaxID. The blinded data in a Kaplan Meier disease-free survival curve for the per-protocol treatment group in the trial showed that approximately 40% of the evaluable patients in the study remained disease-free from 40 months to almost 70 months.
Dr. Steve Arikian, Biovest Chairman and Chief Executive Officer, stated,Biovest believes these results are consistent with the expected efficacy of BiovaxID vs. control. Moreover, BiovaxID has the longest Phase 3 follow-up data for patients receiving an active immunotherapy for follicular Non-Hodgkin's Lymphoma of any of the Phase 3 Non-Hodgkin's Lymphoma immunotherapy trials ongoing today. We are greatly encouraged by the blinded interim data presented at the Jeffries Healthcare Conference on June 27th, 2007.
BiovaxID is an anti-cancer vaccine undergoing testing in a Fast-Tracked pivotal Phase 3 clinical trial for a target indication of Non-Hodgkin's Lymphoma. BiovaxID is a personalized, patient-specific vaccine designed to stimulate the patient's own immune system to recognize and destroy residual cancerous B-cells that remain after the patient has undergone chemotherapy. Unlike many other approaches to treating NHL, BiovaxID is designed to target only cancerous B-cells. The BiovaxID Phase 3 clinical trial is being conducted at fourteen U.S. oncology centers and 8 centers in Russia.
Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by mid-2008. The DMC has agreed to serve as a liaison between the Company and the FDA and the EMEA. If conditionally approved, BiovaxID could become commercially available in early 2009.
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