TAMPA, Fla.--(BUSINESS WIRE)--A majority-owned subsidiary of Accentia Biopharmaceuticals Inc. (NASDAQ:
ABPI), Biovest International, Inc. (OTCBB: BVTI), announced that it has
launched its breakthrough AutovaxID automated cell culture device for
commercial sale.AutovaxID is a fully automated, reusable
instrument that employs a fully disposable, closed-system cell-growth
chamber incorporating a hollow-fiber cell-growth cartridge. This unique
bioreactor replaces conventional stainless steel, glass, and plastic
cell-growth chambers that require up to ten times as much laboratory
space. Because it is fully enclosed and automated, AutovaxID requires
almost no supervision and is less expensive to operate. AutovaxID is the
most advanced commercial cell culture system enabling scalable,
cost-effective production of cells or cell-derived products, including
monoclonal antibodies, for personalized medicine applications.
AutovaxID is suitable for growing antibody-secreting cell lines,
including hybridomas and Chinese hamster ovary (CHO) cells which are
currently the back bone of commercial therapeutic protein manufacture.
The system operates with both suspension- and attachment-dependent
cells. Potential applications of the AutovaxID include growth and
expansion of a wide array of cell types including patient-specific cells
for emerging cell-based and cell-derived therapies. Biovest’s
most advanced clinical product employing the AutovaxID bioreactor is a
personalized vaccine against non-Hodgkin’s
lymphoma which is currently in Phase III testing. This vaccine is
manufactured in the AutovaxID from individual cancer patients’
immune system cells.
AutovaxID is the first cell culture system that enables production of
personalized cell-based treatments economically and in compliance with
U.S. Food and Drug Administration Good Manufacturing Practices (GMPs).
Biovest expects that additional applications for AutovaxID will be in
the field of cell based therapeutics including the use of stem cells to
treat a cancers as well as age-related and other degenerative diseases.
Dr. Steve Arikian, Chairman and Chief Executive Officer of Biovest
commented, "The AutovaxID is a major advance in cell culture for
production of complex biologics, especially in personalized medicine.
Today, companies working on personalized medicine must invest millions
of dollars in dedicated facilities to produce products for clinical
trials. AutovaxID will provide these firms with a low-cost alternative
to expensive cell culture methods, while affording unprecedented
regulatory compliance and manufacturing versatility."
Biovest has manufactured and distributed patented hollow-fiber
cell-culture technologies for more than 20 years. AutovaxID, which
incorporates hollow-fiber membranes, is the Company's next-generation
bioreactor. By automating production and employing closed-system,
single-use components, AutovaxID minimizes costly and error-prone manual
monitoring and adjustments while reducing the need for large production
facilities. AutovaxID will facilitate the emerging field of personalized
medicine by allowing production of personalized therapeutics in far less
costly facilities while still maintaining sterility and strict
segregation of patient-specific materials.
Dr. Arikian added, "We believe the AutovaxID holds great promise in
research settings as well as GMP production due to the instrument’s
ease of use, robust operation, and high productivity. Our market
research suggests a very robust demand for AutovaxID from university,
biotech, pharmaceutical and diagnostics clients who need to produce gram
quantities of antibodies in a single run."
AutovaxIDs are currently used for producing cells and cell derived
products at the Biovest’s National Cell
culture Center located in Minneapolis. The National Cell Culture Center
has utilized Biovest’s proprietary hollow
fiber cartridge technology for the production of hundreds of cell lines
for biomedical researchers over the past 15 years.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused
on the development and commercialization of late-stage clinical products
in the therapeutic areas of respiratory disease and oncology. Two of
these products are SinuNase(TM) and BiovaxID(TM). The Company's SinuNase
product, in development to treat chronic sinusitis (rhinosinusitis), is
a novel application and formulation of a known anti-fungal licensed from
the Mayo Foundation for Medical Education and Research. BiovaxID is a
patient-specific anti-cancer vaccine focusing on the treatment of
follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by
Accentia subsidiary Biovest International, Inc., is currently in a Phase
3 clinical trial. In addition, Accentia's growing specialty
pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of
currently marketed products plus a pipeline of additional products under
development by third parties. For further information, visit the Company
Web site at www.accentia.net.
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, AutovaxID and any other
statements relating to products, product candidates, and product
development programs of Accentia and/or Biovest. Such statement may
include, without limitation, statements with respect to either 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 actual
results of either Accentia 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 Accentia's and/or Biovest's 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 of Accentia and Biovest 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.
