Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that the U.S. National Cancer Institute (NCI)
presented long-term (median 10-year follow-up) outcomes at the 2012
American Society of Clinical Oncology Annual Meeting (ASCO 2012)
from a Phase II BiovaxID® lymphoma vaccine clinical trial. The
results (detailed in Abstract #2528), reported in a poster
presented by the NCI, demonstrated that vaccination following
rituximab combination chemotherapy induced nearly universal T-cell
immune responses, the elevation of which strongly correlated with
overall survival and time-to-next treatment benefits in patients
with mantle cell lymphoma (MCL), a highly aggressive form of B-cell
non-Hodgkin’s lymphoma.
Wyndham H. Wilson, M.D., Ph.D., Chief of the Lymphoma
Therapeutics Section at NCI and the principal investigator of the
MCL study, stated in an article published in Genetic Engineering
& Biotechnology News (GEN), “We found that among MCL patients
treated with a hybridoma-based idiotype vaccine, patients who had
T-cells that produced GM-CSF when exposed to tumor antigen had a
significantly longer survival and delayed time to next treatment
compared to patients who did not have GM-CSF producing T-cells.
Interestingly, studies have shown that GM-CSF producing T-cells are
important for promoting autoimmunity, which is what we hope an
antitumor vaccine will do. In the latter case, the autoimmunity is
against a tumor antigen and not a normal cell.”
Additionally, Sattva S. Neelapu, M.D., Associate Professor at
the Department of Lymphoma/Myeloma, Division of Cancer Medicine,
The University of Texas MD Anderson Cancer Center (Houston, TX), a
co-investigator of this Phase II study and an investigator on the
Phase III (BV301) BiovaxID clinical trial in follicular lymphoma,
commented that, “These results complement the body of data
supporting the safety and efficacy of BiovaxID.”
The study (n=24), with 122 months of median potential follow-up
(range: 111-132 months), demonstrates a median overall survival of
104 months, exceeding reported historic overall survival rates for
‘low-risk’ MIPI patients and substantially exceeding reported
historic overall survival rates for ‘high-risk’ and
‘intermediate-risk’ MIPI patients (See Figure 1). Furthermore, the
study demonstrates a highly statistically-significant association
between overall survival and specific vaccine-induced anti-tumor
GM-CSF cytokine (T-cell) responses.
Overall Survival Benefit in MCL: Patients with a high
degree of this T-cell response to vaccination experienced an
estimated survival of approximately 75% at 10-years, compared to a
survival of approximately 25% in the group of patients with a low
degree of T-cell GM-CSF responses (See Figure 2). Overall, patients
with the T-cell response experienced an approximately three-fold
improvement in their probability of survival compared with those
did not achieve this response to vaccine.
Time-to-Next Treatment Benefit in MCL: In addition to the
overall survival benefit observed, there was also a highly
statistically significant association between the BiovaxID-induced
T-cell response and time-to-next-treatment benefit with a nearly a
10-fold improvement for those patients that developed this specific
BiovaxID-induced T-cell response versus those who did not (51.9
months versus 5.5 months from the time of first progression) (See
Figure 3).
According to Carlos F. Santos, Ph.D., Biovest’s Senior Vice
President, Product Development & Regulatory Affairs, “We
believe that these study results from the Phase II bridging study
conclusively demonstrate that BiovaxID vaccine consolidation
engenders strong anti-tumor T-cell immune responses following
rituximab-combination chemotherapy which correlate with long-term
clinical benefits. With our vaccine’s T-cell activating properties,
long persistence of effect, high degree of safety and a mechanism
of action that complements rituximab, BiovaxID represents an
urgently needed non-immunosuppressive consolidation therapeutic
option for lymphoma patients. These study results suggest that with
minimal toxicity, BiovaxID induces tumor-specific T-cell responses
which could dramatically slow tumor growth and improve survival in
lymphoma patients.”
BiovaxID MCL Study Conclusions
- At 11-years follow-up, post-vaccination
GM-CSF producing anti-tumor T-cells were significantly associated
with overall survival and time-to-next-treatment benefits.
- Results suggest that post-vaccination
GM-CSF producing T-cells induce clinically significant anti-tumor
effects which could slow tumor growth and improve survival.
- Pre-treatment GM-CSF producing
anti-tumor T-cells correlated with post-treatment enhancement of
immune response, suggesting a priming effect.
- This is the first evidence that
idiotypic vaccination may improve survival of MCL, an aggressive
B-cell subtype of non-Hodgkin’s lymphoma for which there is no
current consensus standard-of-care.
The article published in Genetic Engineering & Biotechnology
News (GEN) covering Biovest’s latest exciting BiovaxID MCL study
results can be accessed in the Media Center at Biovest’s corporate
website at:
http://www.biovest.com/investor-relations/media-center
About Biovest International,
Inc.
Biovest International, Inc. is an emerging leader in the field
of active personalized immunotherapies. In collaboration with the
National Cancer Institute, Biovest has developed a
patient-specific, cancer vaccine, BiovaxID®, with three clinical
trials completed, including a Phase III study, demonstrating
evidence of safety and efficacy for the treatment of indolent
follicular non-Hodgkin’s lymphoma.
Headquartered in Tampa, Florida with its bio-manufacturing
facility based in Minneapolis, Minnesota, Biovest is
publicly-traded on the OTCQB™ Market with the stock-ticker symbol
“BVTI”, and is a majority-owned subsidiary of Accentia
Biopharmaceuticals, Inc. (OTCQB: “ABPI”).
For further information, please visit:
http://www.biovest.com
Forward-Looking
Statements:
Statements in this presentation/interview that are not
strictly historical in nature constitute "forward-looking
statements.” Such statements include, but are not limited
to, statements about Biovest and its product candidate, BiovaxID®
and any other statements relating to products, product candidates,
product development programs, the FDA, the EMA, Health Canada or
clinical study process including the commencement, process, or
completion of clinical trials or the regulatory process.
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. In
particular (and without limitation), statements regarding the
timing of anticipated filing of a Marketing Authorization
Application for BiovaxID with the EMA or a New Drug Submission for
BiovaxID with Health Canada, pre-filing meetings with the FDA or
other jurisdictions and/or commercial plans reflect current
expectations but are subject to inherent risks of delay in
compilation and finalization of all components of the licensing
application. Such forward-looking statements involve known and
unknown risks, uncertainties, and other factors that may cause the
actual results of 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 Biovest undertakes
no obligation to revise or update this news release to reflect
events or circumstances after the date hereof. The product
names used in this statement are for identification purposes
only. All trademarks and registered trademarks are the
property of their respective owners.
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