Biovest Announces BiovaxID® ASCO Abstract Available On-line; NCI to Present Cancer Vaccine Data from Mantle Cell Lymphoma St...
May 18 2012 - 10:24AM
Business Wire
Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that an abstract reporting new data from the
BiovaxID® Phase II mantle cell lymphoma clinical trial conducted by
the U.S. National Cancer Institute (NCI) is now available on-line
with the significance of these results to be presented by the NCI
at the 2012 American Society of Clinical Oncology Annual Meeting
(ASCO 2012).
The abstract (#2528), titled, “Association of idiotype
vaccine-induced T-cell response with improved survival and
time-to-next treatment (TTNT) in untreated mantle cell lymphoma
(MCL)”, is now available on-line at the ASCO website at:
http://abstract.asco.org/AbstView_114_100528.html.
Biovest will further comment on these results following the
NCI’s presentation at ASCO on Saturday, June 2nd in a poster
presentation session from 8:00 am – 12:00 pm CST in Room S405,
followed by a poster discussion session at 12:00 pm CST, also in
Room S405, at the McCormick Place Convention Center in Chicago.
According to Biovest’s President and CEO, Samuel S. Duffey,
Esq., "The long-term commitment of the clinicians at the NCI to the
potential of cancer vaccines to treat lymphoma is a tribute to the
role of our federal government in the ongoing fight against cancer.
BiovaxID was developed under a Cooperative Research and Development
Agreement (CRADA) between Biovest and the NCI, and Biovest's
ongoing progress is to a large degree due to the pioneering vision
of NCI clinicians and their effort that has spanned almost two
decades. We are indeed proud to have participated in such an
important public/private partnership.”
To meet with Biovest at ASCO 2012, please contact Douglas Calder
at 813-507-2633 or dwcalder@biovest.com.
About BiovaxID®
Biovest's lead drug product is BiovaxID®, an autologous active
immunotherapy (personalized cancer vaccine) for the treatment of
certain B-cell subtypes of non-Hodgkin's lymphoma, an incurable
form of blood cancer. Over the past decade, two Phase II clinical
trials and a Phase III clinical trial have demonstrated strong and
cumulative evidence with regards to BiovaxID’s safety and efficacy.
With regards to safety, all clinical trials to date demonstrate
that BiovaxID vaccination is highly safe and poses a nearly
vanishingly small toxicity risk relative to approved anti-lymphoma
agents. Moreover, BiovaxID provides substantial and durable
clinical efficacy with the Phase III clinical trial demonstrating
that BiovaxID significantly improves disease-free survival over 15
months (Check/verify extension) in follicular lymphoma and the
Phase II mantle cell lymphoma clinical trial demonstrating that
BiovaxID induces strong idiotype-specific T-cell responses which
correlate with highly-statistically significant overall
survival.
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.