-
Company Closes Phase 3 Fast-Tracked Clinical Trial
-
Will Petition to Offer All Study Patients Treatment with BiovaxID
-
Intends to Seek Approval in the U.S. and Internationally
Biovest International, Inc. (OTCBB:BVTI), a majority-owned subsidiary of
Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), today provided an
update on its personalized, anti-cancer vaccine, BiovaxID®,
including reporting clinically and statistically significant data from
its randomized controlled pivotal Phase 3 Fast-Tracked clinical trial
for the treatment of indolent follicular non-Hodgkin’s
lymphoma, an often fatal blood cancer. After a recent meeting with the
FDA, the Company closed the clinical trial, unblinded the patients, and
analyzed the disease-free survival in both arms through June 30, 2008.
The Company has committed to provide the FDA with a detailed clinical
report based on this end-of-study data, including statistical analysis,
prior to the next meeting in order to discuss a petition to treat all
patients in the clinical trial with BiovaxID and to seek Accelerated
Approval under subpart E. Originally, the study was intended to follow
patients in both arms after unblinding for the purpose of determining
overall survival, but based on the trial results, the Company now
believes that it would be unethical to withhold BiovaxID from control
patients, and that the study, therefore, is closed. Beyond the Company’s
U.S. strategy, Biovest disclosed plans regarding preparations to seek
approvals in Europe (EU and select non-EU countries), Asia and Australia.
BiovaxID Summary Results for End of
Study:
Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s
lymphoma. Randomization required that patients achieve a complete
clinical remission (CR or CRu) following chemotherapy. Both arms of the
clinical trial are well-balanced in terms of stage and degree of
malignancy and in terms of patient characteristics at enrollment and
randomization. The intent-to-treat (ITT) analysis from the point of
randomization for all patients in the trial who received at least one
dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID
versus control) showed that the median duration of complete remission in
the BiovaxID arm of the study was 44.2 months which is clinically and
statistically significant compared to the control arm, median duration
of cancer-free survival of 30.6 months. BiovaxID prolonged the
cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6)
with a median follow up of 56.6 months (range 12.6 to 89.3 months).
The time point at which the difference in disease-free survival between
the two arms was greatest was approximately 36 months. At 36 months, 61%
of BiovaxID patients and 37% of control patients were cancer-free,
meaning that BiovaxID patients were 65% more likely to be cancer-free
than were the control patients (p-value = 0.023; HR = 1.9). The Company
believes that the data suggests that this might be an optimal time for
supplemental booster shots, expected to further enhance the maintenance
of clinical remissions.
With regards to safety, there was not a single serious adverse event
that was definitely ascribed to BiovaxID.
According to study investigator, Dr. Christopher Flowers, these results
herald a new era of personalized medicines in targeting cancers: “I
am impressed that these results for BiovaxID represent a breakthrough
for the treatment of non-Hodgkin's lymphoma and ultimately for many
other kinds of B-cell blood cancers." Dr. Flowers serves as Assistant
Professor of Hematology and Oncology at Winship Cancer Institute at the
Emory University School of Medicine. He also directs the Lymphoma Clinic
at Emory and is a past recipient of the clinical and translational
research awards that provide grant funding for exciting new research in
hematology.
Biovest’s Chairman and CEO, Dr. Steven
Arikian, commented on the Company’s plans to
seek U.S. and international approvals for BiovaxID: “We
believe that these strongly positive clinical results make it unethical
to continue the trial as originally designed. In particular, we believe
that we should offer BiovaxID to patients in the control arm who have
not relapsed yet, and to patients in both arms who have relapsed but who
can achieve another complete remission. Accordingly, we will be seeking
a petition to treat these patients with BiovaxID and to file for
Accelerated Approval in the U.S. Moreover, based on the data at 36
months, we believe that BiovaxID patients in complete remission
post-vaccination should be getting booster shots at about this time
frame to maximize their chances of maintaining complete remissions. We
are preparing to make submissions with the European Medicines Agency
(EMEA) related to the approval process for the European Union (EU), as
well regulatory agencies in select European nations (non-EU), Australia,
and select Asian countries.”
A Unique Approach to Immunotherapy
Targeting B-Cell Blood Cancers:
B-cells (a type of white blood cell or lymphocyte) are a vital part of
the human immune system, as they produce antibodies that seek out and
bind to foreign substances in the body.