Message #9 From:
NewsBot Date: October 19, 2006 05:30:00 AM
BVTI News Biovest International's Phase 3 Therapy for Follicular Lymphoma Receives Independent Support From Newly Published Phase 2 Trial Data
WORCESTER, Mass.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB: BVTI) announced that a publication
in the September 20th issue of the Journal of the National Cancer
Institute provides support for its ongoing phase 3 trial of BiovaxID, an
autologous immunotherapy for follicular non-Hodgkin’s
Lymphoma. The publication, entitled “Clinical
Benefit Associated With Idiotypic Vaccination of Patients With
Follicular Lymphoma” by Susana Inoges, et al
(Journal of the National Cancer Institute, Vol. 98, No 18, 2006,
pp1292-1301), was based on research conducted at the Oncology Division
of the University of Navara, in Pamploma, Spain.
In the study 25 patients with indolent follicular lymphoma who had
relapsed after chemotherapy (including approximately 1/2 who had
received Rituxan therapy) were put into a second remission with CHOP
chemotherapy followed by vaccination with anti-idiotype vaccine. Of the
25 patients immunized, 20 developed a measurable anti-idiotype immune
response. All of the responders with sufficient follow up for a
comparison to be made experienced a second complete response that was
significantly longer (P<0.0001) than their
first response and than the median length of typical CHOP-induced second
complete responses. The authors note that it is highly unusual if not
unique that a second remission in this disease would be longer than the
first, suggesting that this hybridoma-derived anti-idiotype
immunotherapy represents a new treatment paradigm for this disease.
Significantly, the median DFS for the second vaccine-associated
remission has not been reached, but is >33
months; median DFS for 1st remission was 17 months. The authors conclude
that "Specific immune response was associated with a dramatic and highly
statistically significant increase in disease free survival. This is the
first formal demonstration of clinical benefit associated with the use
of a human cancer vaccine." (J Natl Cancer Inst 2006; 98:1292-1301).
Dr. Steve Arikian, Biovest CEO and Chairman commented, “We
are very pleased with the results of this new phase 2 trial from the
University of Navara. This group used the same hybridoma method to
produce their anti-idiotype vaccines as we use at Biovest. We are
confident that these impressive results are supportive of the great
potential value of our therapy, and even suggest a benefit for extended
booster immunizations, for which Biovest will be well prepared when we
go to market. We are especially pleased to see that the study suggests a
benefit of this therapeutic approach even after relapse following
administration of Rituxan. This independent validation comes at a
pivotal point in out own trial, as we ramp up patient recruitment and
prepare for commercial launch following approval. Our unique ability to
efficiently manufacture the active component of these vaccines in our
AutovaxID instruments will enable us to meet what we believe will be a
significant demand in the worldwide market.”
About Biovest International, Inc.
Biovest International, Inc. is a pioneer in the development of advanced
individualized immunotherapies for life-threatening cancers of the blood
system. Biovest is a majority-owned subsidiary of Accentia
Biopharmaceuticals, Inc. (NASDAQ: ABPI), with its remaining shares
publicly traded. Biovest has a foundation in the manufacture of
biologics for research and clinical trials. In addition, Biovest
develops, manufactures and markets patented cell culture systems,
including the innovative AutovaxID™,
which is being developed as an automated vaccine manufacturing
instrument and for production of cell-based materials and therapeutics.
Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in
a Phase 3 pivotal clinical trial at more than 20 major medical centers
throughout the U.S. For further information, visit the Company Web site
at http://www.biovest.com.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but
are not limited to, statements about BiovaxID™
and any other statements relating to products, product candidates, and
product development programs. Such statements may include, without
limitation, statements with respect to the Company's plans, objectives,
expectations and intentions and other statements identified by words
such as "may," "could," "would," "should," "believes," "expects,"
"anticipates," "estimates," "intends," "plans" or similar expressions.
Such forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause the actual results of
Accentia and/or Biovest to be materially different from historical
results or from any results expressed or implied by such forward-looking
statements. These factors include, but are not limited to, risks and
uncertainties related to the progress, timing, cost, and results of
clinical trials and product development programs; difficulties or delays
in obtaining regulatory approval for product candidates; competition
from other pharmaceutical or biotechnology companies; and the additional
risks discussed in filings with the Securities and Exchange Commission.
All forward looking statements are qualified in their entirety by this
cautionary statement, and neither Accentia nor Biovest undertakes any
obligation to revise or update this news release to reflect events or
circumstances after the date hereof.
