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Overall median disease-free-survival increased by more than one year
(p-value = 0.047)
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100% improvement in disease-free-survival at three years (p-value =
0.024)
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Potential to be first ever anti-cancer vaccine approved in U.S. and/or
Europe
Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), 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.
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.
