Non-Hodgkins Lymphoma Vaccine Shows Promise (ABPI, BVTI)
Biovest International, Inc. (OTCBB:BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI). This morning the company has what appears to be some very positive cancer vaccine data. It released clinically and statistically significant unblinded data from a randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID(R) (personalized anti-idiotype vaccine). This is for the treatment of indolent follicular non-Hodgkin’s lymphoma (NHL), which is an often fatal blood cancer.
This was originally developed and advanced into human clinical trials by the National Cancer Institute, and BiovaxID is designed to recruit the immune system to recognize and destroy only cancerous B-cells. Based on the highly encouraging clinical evidence reporting on vaccinated patients to date, Biovest plans to proceed with plans to seek accelerated
and/or conditional regulatory approvals in the U.S. and European Union.
The first result for vaccinated patients followed up to 80 months showed that 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. This was compared to the BiovaxID arm which had a median time to relapse of 33.8 months. This statistically significant difference represents an increase of approximately 60% in the duration of complete remission since first vaccination. Disease-free survival was the primary endpoint of the study.
The second result 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.
So far after 90 minutes of trading (11:00 AM EST) we have seen Accentia (ABPI) trade up over 10% at $0.94 and Biovest (BVTI) is up by more than 50% at $0.51 today.
Jon Ogg
July 17, 2008