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Avantogen Limited, (formerly Australian Cancer
Technology Limited "AustCancer")(ASX:ACU), and Hawaii Biotech, Inc.
(HawaiiBio) today announced that they have signed an important
worldwide, nonexclusive License Agreement under which HawaiiBio will
evaluate Avantogen's proprietary adjuvant GPI-0100. HawaiiBio will
develop a series of vaccines for infectious diseases and pay
Avantogen milestones, sublicense fees, and royalties as their
products which utilize GPI-0100 move to market.
Avantogen's lead adjuvant-immunopotentiator, GPI-0100, a key
component of vaccines for boosting the immune response, will be
evaluated by HawaiiBio initially with vaccines for West Nile virus and
dengue fever. In the case of West Nile Virus, the U.S. market
potential for treating individuals at "increased risk" is estimated to
be nearly $1 Billion.
In the last three years, HawaiiBio has received $33 million in the
most competitive funding from the National Institutes of Health and
other federal and state agencies. Hawaii Biotech, Inc. is privately
held and is engaged in the research and development of human
vaccines, based on the production of proprietary antigens (proteins)
that produce immune responses equivalent to, or better than,
traditional live or inactivated virus approaches -- with a
significantly improved safety profile. Hawaii's platform technology is
applicable to a wide variety of diseases including West Nile, dengue
fever, hepatitis C, malaria, Japanese encephalitis, Ebola, Eastern
equine encephalitis and others. The Company's vaccine technology was
featured on the cover of the prestigious scientific journal Nature
on January 22, 2004.
Virtually unknown in the U.S. prior to 1999, the West Nile virus
is now permanently established throughout the U.S. and Canada. In an
estimated 1 of 150 infected with West Nile, encephalitis and
meningitis will occur, characterized by polio-like symptoms. Live,
attenuated virus vaccines being developed by potential competitors
have a small but real risk of causing severe, encephalitic West Nile
disease. Hawaii Biotech's approach utilizes genetically engineered
viral proteins that cannot cause disease, which confers a substantial
safety advantage.
Unlike most human viral diseases, West Nile causes both disease
and death in animals. A well-validated model of human West Nile
disease, the golden hamster, has been developed by Robert B. Tesh,
M.D., of the University of Texas Medical Branch-Galveston and one of
the leading researchers in this field. Dr. Tesh tested two
formulations of Hawaii Biotech's West Nile vaccine in this model. 100%
of the animals in Hawaii Biotech's two vaccine groups remained alive
and healthy, compared to 77% mortality in the control group.
Avantogen's GPI-0100 product is currently under license to Pfizer
Animal Health Inc and Endocyte Inc. as an adjuvant to boost immunity
of their vaccine-based products. Furthermore, Avantogen is actively
seeking further licensees to adopt GPI-0100 as their preferred
adjuvant as a component of their vaccines.
Dr. Firestone, CEO of Avantogen, said, "We are excited about the
potential applications of GPI-0100 in the treatment of infectious
disease. I am pleased to see that our investments in GMP manufacture
at Dr Reddys, and our filing of a Drug Master File with the US FDA,
are bearing fruit. To service the needs of our collaborators and
licensees, we are manufacturing GPI-0100 under fully FDA compliant
GMP; this is being undertaken by Dr. Reddys."
The GPI-0100 adjuvant, which has been shown to significantly
enhance the immune response with a variety of vaccines, has been shown
to have good overall performance characteristics on safety and
efficacy. GPI-0100 is Avantogen's lead compound for use in the active
immunotherapy of cancer and some chronic infectious diseases. A
proprietary semi-synthetic saponin derivative, GPI-0100 acts by
up-regulating the body's immune system and stimulating both humoral
and an effective T-cell immunity with CTL production. Compared with
other immune stimulatory saponins, GPI-0100 has superior stability and
safety profile, making it an ideal candidate for the development of
novel therapeutics or preventive vaccines.
About Avantogen (www.avantogen.com)
Avantogen is an international biotechnology Company developing a
broad oncology-related product portfolio. Avantogen has acquired the
North American marketing rights for RP101, a promising pancreatic
cancer drug and is currently conducting Phase II clinical studies
through a subsidiary company, Resistys Inc, a joint venture with
Bioaccelerate of New York. Avantogen's Pentrys(TM) anti-cancer vaccine
is being evaluated in prostate cancer patients in Phase IIb clinical
studies, and the Avantogen Limited Company is advancing several immune
enhancing adjuvants, including GPI-0100, which have been in three
Phase I cancer trials in the U.S. The immune-enhancing adjuvants were
developed by Galenica, a privately held U.S. vaccine developer.
Avantogen acquired Galenica in July 2004. The Company also markets
revisys(TM), a branded line of medical nutritionals designed for
people with special needs, including those undergoing cancer
treatments.
Forward-Looking Statements
Statements contained in this press release that are not historical
information are forward-looking statements as defined within the
Private Securities Litigation Reform Act of 1995. Such forward-looking
statements are subject to risks and uncertainties that could cause
Avantogen's ("company") actual results to differ materially from those
projected or implied. Such potential risks and uncertainties relate,
but are not limited, to the results of clinical trials, product demand
and market acceptance, the impact of competitive products and pricing,
effectiveness and pace of current and future product development, and
regulatory approval. More detailed information on these and additional
factors that could affect the company's operating and financial
results are described in the company's annual reports filed or to be
filed with the Australian Stock Exchange. The company urges all
interested parties to read these reports to gain a better
understanding of the many business and other risks that the company
faces. The historical results achieved by the company are not
necessarily indicative of its future prospects. The company undertakes
no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.