July 18, 2008
Biovest Reports Positive Results From Phase III Lymphoma Trial
Biovest International, a majority-owned subsidiary of Accentia Biopharmaceuticals, has announced clinically and statistically significant unblinded data from its randomized controlled pivotal Phase III fast-tracked clinical trial of BiovaxID for the treatment of indolent follicular non-Hodgkin's lymphoma, an often fatal blood cancer.
Biovest reported on two clinically relevant data points - overall median disease-free survival data as measured up to 80 months; and disease-free survival data on these same patients as measured at three years.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).
Based on this study's encouraging clinical evidence reported on vaccinated patients to date, including efficacy and safety, Biovest intends to move forward with plans to seek accelerated or conditional regulatory approvals in the US and EU, respectively.