Vical Incorporated
(Nasdaq: VICL) announced today that the company has signed a Cooperative
Research and Development Agreement (CRADA) with the Naval Medical Research
Center (NMRC), a biomedical research organization within the U.S. Navy, to
explore the use of Vical's novel Vaxfectin(TM) adjuvant with experimental
DNA vaccines against malaria. Vaxfectin(TM) is a cationic lipid/co-lipid
formulation designed to increase the immune response to vaccines.
The company holds patents in the United States and Europe covering a
new class of adjuvants including Vaxfectin(TM) and their use with DNA
vaccines, as well as patents in the United States covering the use of
Vaxfectin(TM) with conventional vaccines based on proteins, polypeptides,
and polysaccharides, including those containing all or part of a bacterial
or viral pathogen. Vical has provided Vaxfectin(TM) to academic researchers
for several years, and data have been published showing evidence of
increased immunogenicity and/or protective efficacy of DNA vaccines against
diseases including anthrax (Vical), tuberculosis (Pasteur Institute of
Brussels), HIV (UC-San Francisco), Japanese Encephalitis Virus (Kobe U.
School of Medicine), influenza (Vical), and malaria (NMRC) in animal models
ranging from mice to non-human primates.
"We expect initial human testing of a Vaxfectin(TM)-formulated DNA
vaccine to begin in the second half of 2007 in our pandemic influenza
program," said Vijay B. Samant, Vical's President and Chief Executive
Officer, "potentially paving the way for other applications to advance into
clinical-stage development. We believe the potential of this new class of
adjuvants is quite broad, including DNA vaccines and conventional vaccines
against infectious diseases or cancer. We are especially pleased to expand
our collaboration with the U.S. Navy on the malaria vaccine development
program with the Vaxfectin(TM) adjuvant."
Vaxfectin(TM) was developed to boost the immune response to DNA
vaccines, but also has been shown to boost the immune response to a
conventional seasonal influenza vaccine. In mouse studies, conventional
influenza vaccines (Sanofi-Pasteur Fluzone(R) 2005-2006 Formula commercial
product) formulated with Vaxfectin(TM) yielded significantly higher
hemagglutination inhibition titers, the accepted standard correlate of
protection, than unformulated vaccines at even an approximately 10-fold
higher dose. Results from the study suggest that Vaxfectin(TM) has the
potential to be used as a dose-sparing agent with conventional influenza
vaccines against seasonal or possibly pandemic influenza strains.
The NMRC plans to conduct a series of antigen screening tests and
further development in several animal models of malaria to optimize the
design of a vaccine potentially leading to initial testing in humans. The
Vaxfectin(TM)-formulated vaccine will be designed to elicit both T-cell and
antibody immune responses.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements about
Vical's technology and its current and potential applications, the scope of
coverage of and potential applications for the company's issued and future
patents and the potential uses and benefits of Vaxfectin(TM), as well as
the company's focus, collaborative partners, and product candidates. Risks
and uncertainties include whether the company's technology will be
successfully applied by the NMRC or others; whether the company's issued
patents will be challenged and whether such challenges will have an adverse
effect on the scope of the patents; whether the company will enforce its
issued patents or will be successful in any enforcement efforts; whether
the company will successfully prosecute additional patent applications and
whether such applications will lead to the issuance of additional patents;
whether we will begin human testing of a Vaxfectin-formulated vaccine as
anticipated in the second half of 2007, or at all; whether Vaxfectin(TM),
if used as an adjuvant in any vaccine in human clinical trials, will be
safe and effective at enhancing the immune response; whether the company or
any of its collaborative partners will incorporate Vaxfectin(TM) into any
of their products; whether Vical or others will continue evaluation of
Vaxfectin(TM) as an adjuvant for conventional vaccines against seasonal or
pandemic influenza; whether Vaxfectin(TM) will be used as a dose-sparing
agent with conventional influenza vaccines against seasonal or pandemic
influenza strains; whether Vical or others will continue development of the
pandemic influenza DNA vaccine candidate; whether any strains of influenza
will emerge as pandemic threats; whether the company's DNA vaccine
candidate will be effective in protecting humans against emerging strains
of influenza; whether the influenza vaccine or any other product candidates
will be shown to be safe and effective; the timing, nature and cost of
clinical trials; whether Vical or its collaborative partners will seek or
gain approval to market any product candidates; whether Vical or its
collaborative partners will succeed in marketing any product candidates;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
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