Title: Vical Expands Testing of Vaxfectin(TM) Adjuvant to U.S. Navy
Malaria Vaccine Program Date: 4/19/2007 6:30:00 AM
SAN DIEGO, April 19, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- 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 www.vical.com.
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.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
(858) 646-1127 (619) 849-6007
Website: www.vical.com
SOURCE Vical Incorporated
Investors, Alan R. Engbring of Vical Incorporated, +1-858-646-1127; or Media, Susan
Neath of Porter Novelli Life Sciences, +1-619-849-6007, for Vical Incorporated
http://www.vical.com
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