Avantogen's Vaccine Adjuvant GPI-0100 Licensed by Hawaii Biotech Inc.; GPI-0100 Is Licensed Initially for West Nile Virus and De
October 12 2005 - 9:13PM
Business Wire
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.
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