Biovest Reports Results for Patients Treated with Anti-Cancer Vaccine: BiovaxID(R) Demonstrates Clinically and Statistically Significant Improvement of Disease-Free Survival in Non-Hodgkin's Lymphoma in Pivotal Phase 3 Clinical Trial
Thursday July 17, 11:17 am ET
-- Overall median disease-free-survival increased by more than one year (p-value = 0.047)
-- 100% improvement in disease-free-survival at three years (p-value = 0.024)
-- Potential to be first ever anti-cancer vaccine approved in U.S. and/or Europe
TAMPA, Fla.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB:BVTI - News), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News), today announced clinically and statistically significant unblinded data from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® (personalized anti-idiotype vaccine) for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), an often fatal blood cancer. Originally developed and advanced into human clinical trials by the National Cancer Institute (NCI), BiovaxID is designed to recruit the immune system to recognize and destroy only cancerous B-cells. Based on this study’s highly encouraging clinical evidence reporting on vaccinated patients to date, including efficacy and safety, Biovest intends to move forward with plans to seek accelerated and/or conditional regulatory approvals in the U.S. and European Union, respectively.
Source: Biovest International, Inc.
· BiovaxID Phase 3 Disease Free Survival Results (Graphic: Business Wire). View Multimedia Gallery
Summary Results:
Biovest reported on two clinically relevant data points: 1) Overall median disease-free survival data as measured up to 80 months; and 2) Disease-free survival data on these same patients as measured at three years. All analyses performed were predetermined prior to unblinding and consistent with the Statistical Analysis Plan that was submitted and accepted by the FDA and the data review performed by the independent Data Monitoring Committee (DMC), which is vested with the responsibility for monitoring the safety and efficacy of the BiovaxID trial.
First, for vaccinated patients followed up to 80 months, the overall results showed that BiovaxID improved median disease-free-survival by more than one year with the control arm showing a median time to relapse from first vaccination of 21.2 months, as compared to the BiovaxID arm which had a median time to relapse of 33.8 months. This statistically significant difference (p-value = 0.047) represents an increase of approximately 60% in the duration of complete remission since first vaccination. Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study.
Second, for these same patients measured at 36 months from vaccination, BiovaxID improved median disease-free-survival by approximately 100% - a statistically significant improvement as compared to the control group (p-value = 0.024).
See Accompanying Graph Showing Disease-Free Survival Curves
Biovest intends to seek accelerated and/or conditional approvals immediately in the U.S. and Europe, respectively, based on the current unblinded data and plans to supplement the clinical analysis with additional follow-up data through August 29, 2008, as per the recommendation of the DMC.
According to the Leukemia & Lymphoma Society, non-Hodgkin’s lymphoma is the 5th leading cause of new cancer cases in the U.S., with an estimated 63,190 new cases of NHL to be diagnosed in 2008, with approximately 18,660 deaths expected to be attributed to the disease. In Europe, NHL is the 6th most common form of cancer with approximately 50,000 new cases diagnosed each year in the European Union alone.
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No interest?? PR from a couple of days ago. They made a basic mistake and now they are screwed. Someone needs to start a clinic in Mexico for something like BiovaxID because it is too damn bad. |
