Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that the Max Planck Society recently hosted a
research seminar in Berlin, Germany at which the Max Planck
Institute for Dynamics of Complex Technical Systems (Magdeburg,
Germany) presented highly encouraging viral growth data from
studies using a Biovest proprietary hollow fiber bioreactor system
to produce human influenza virus. The results reported by the Max
Planck Institute were consistent with earlier studies conducted by
the U.S. Naval Health Research Center (NHRC) finding that Biovest’s
instruments offer a flexible and modular manufacturing platform for
the rapid, robust and cost-effective production of virus for
vaccine production.
Biovest's AutovaxID™ bioreactor
represents a novel manufacturing platform for the production of
viral vaccines and personalized medicines. (Photo: Business
Wire)
According to Dr. Yvonne Genzel (Max Planck Institute), a
recognized expert in the field of bioprocess engineering, influenza
virus production and bioreactor systems, “Our preliminary results
suggest that Biovest’s hollow fiber technology may provide a novel
solution for urgently needed improvements in the cell culture
manufacture of viral vaccines. The Biovest instrument we used in
our preliminary studies supported the growth of both adherent and
suspension MDCK cells with high titers of H1N1 virus. Our next
studies will implement further optimization and scale-up techniques
in Biovest’s AutovaxID® bioreactor which we expect may further
improve the already encouraging results.” These initial study
results are expected to be published in a peer-reviewed
journal.
In addition to the Max Planck Institute, Biovest is
collaborating with the NHRC and U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID) on additional studies
utilizing Biovest’s hollow fiber technology for production of
vaccines, virus-like particles (VLPs) and antibodies for treatment
and prevention of influenza and filovirus diseases including those
caused by Ebola and Marburg viruses.
According to Biovest’s consulting medical advisor, J. David
Gangemi, Ph.D., Professor Emeritus, Microbiology and Molecular
Medicine, Clemson University, “In a series of world-class
collaborative studies, we’re establishing the utility, versatility
and flexibility of Biovest’s hollow fiber perfusion systems as an
optimal cell culture biomanufacturing platform. Additionally, based
on our success to date, there is considerable interest being
expressed from other companies, government agencies and research
institutes which I believe will result in new contracts and
collaborations to be established this year.”
To review the viral growth study results previously reported by
the NHRC and published in Genetic Engineering & Biotechnology
News (GEN), please visit:
http://www.genengnews.com/gen-articles/novel-uses-for-hollow-fiber-bioreactors/3700/
Biovest’s patented hollow fiber bioreactor systems are compact,
scalable and economical for large-scale virus and antibody
production. In contrast to other systems, Biovest’s technology
provides multiple benefits including: 1) controlled culture
conditions with high cell density attained; 2) space efficiency and
high-yield production; and 3) selective dilution/removal of
inhibitory byproducts.
AutovaxID® is an automated, self-contained, scalable system that
employs a single-use, hollow-fiber bioreactor for cell expansion.
Since it is functionally closed, computer-controlled and
fully-automated, operation of the AutovaxID requires limited
supervision and minimal manpower compared to other systems. The
AutovaxID is a flexible system, uniquely designed to address a
variety of biotechnology and pharmaceutical applications.
About the Max Planck
Institute
The Max Planck Institute for Dynamics of Complex Technical
Systems is part of the Max Planck Society, Germany’s most
successful research organization with more than 17 Nobel laureates
having emerged from the rank of its scientists.
About Biovest International,
Inc.
Biovest International, Inc. develops active immunotherapies
(cancer vaccines) which treat and diminish the aggressiveness of
B-cell non-Hodgkin’s lymphoma, a cancer of the immune system. The
Company’s lead personalized cancer vaccine product candidate,
BiovaxID™, has been evaluated in three clinical trials conducted in
collaboration with the U.S. National Cancer Institute (NCI)
demonstrating that BiovaxID increases the duration of cancer
remission following chemotherapy and induces immune responses which
correlate highly with long-term survival. Biovest is currently in
the process of seeking US and international marketing approvals for
BiovaxID.
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 press release 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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