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
Anti-Cancer Vaccine Data Creates Two Huge Moves (BVTI, ABPI)
There are two tiny stocks that are benefiting from some positive Phase III data on an anti-cancer vaccine. Biovest International, Inc. (OTCBB: BVTI) is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), and this morning the company reported what it noted as “the company believes” to be highly encouraging blinded results from its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial of BiovaxID® for the treatment of indolent follicular non-Hodgkin’s lymphoma. This is an often fatal blood cancer.
It reported a blinded disease-free survival data for patients that have completed 36 months of follow-up subsequent to randomization in both the treatment and control arms, with one arm demonstrating 100% improvement in disease-free survival over the other arm.
Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study. With a “fast track designation” from the FDA and with a 100% improvement over the other arm, you can imagine the interest in such a small company.
Accentia Biopharmaceuticals, Inc. (ABPI) has a mere $61.5 million market cap and that is after a 24% gain today to $1.36. Its 52-week trading range is $0.65 to $3.39. As of March 31, 2008, its balance sheet was inverted and that doesn’t make this any assured home run by a financial count. Biovest International (BVTI) is seeing a surge of 26% to $0.52 today, and its market cap is only about $50 million.
Jon Ogg
June 11, 2008