Vical Incorporated
(Nasdaq: VICL) today announced that a seasonal influenza vaccine formulated
with the company's Vaxfectin(TM) adjuvant generated up to 60-fold higher
antibody responses than an unformulated vaccine at the same dose in a
recently completed study in mice. Formulation of sanofi pasteur's
Fluzone(R) commercial vaccine with Vaxfectin(TM) also allowed a nearly
10-fold reduction in vaccine dose while generating equivalent or better
antibody responses compared with unformulated vaccine, even at the lowest
doses tested. Alain P. Rolland, Pharm.D., Ph.D., the company's Senior Vice
President of Product Development, presented the data at the Drug Delivery
2007 meeting (San Francisco, April 9 - 11).
Vical is developing its own Vaxfectin(TM)-formulated DNA vaccine
designed to protect against emerging strains of influenza virus that have
the potential to cause a pandemic. In previously reported studies conducted
at St. Jude Children's Research Hospital, Vical's lead
Vaxfectin(TM)-formulated, DNA vaccine candidate provided 100% protection in
mice and ferrets against lethal challenges with a highly pathogenic strain
of H5N1 influenza virus. Initial human testing of Vical's influenza DNA
vaccine is expected to begin in the second half of 2007.
Vical tested the Vaxfectin(TM) adjuvant with Fluzone(R) seasonal
influenza vaccine to evaluate its potential to ease the anticipated
shortage of stockpiled pandemic influenza vaccine and the limited global
vaccine manufacturing capacity. In separate studies conducted by others,
stockpiled sanofi pasteur H5N1 pandemic influenza vaccine with no adjuvant
achieved target levels of antibodies in less than half the subjects after
two 90 mcg doses -- a total of six times the normal 15 mcg dose of each
strain that provides 75% to 90% protection against seasonal influenza.
The new Fluzone(R) study data confirm and expand on an earlier study in
mice, presented last year, which suggested the potential for Vaxfectin(TM)
to be used as a dose-sparing agent with conventional influenza vaccines.
Both studies used the Fluzone(R) 2005-2006 Formula trivalent inactivated
seasonal influenza vaccine. In the recent study, mice were vaccinated with
1, 3, or 9 mcg of Fluzone(R) alone, or Fluzone(R) formulated with one of
two dose levels of Vaxfectin(TM). Immune responses were evaluated by
measuring hemagglutination inhibition (HI) antibody titers, the accepted
standard correlate of protection for conventional influenza vaccines,
against a single influenza strain included in the trivalent inactivated
vaccine, as well as total antibody titers against all three of the strains
included in the vaccine. Vaxfectin(TM)-formulated vaccines yielded HI
antibody titers up to 30-fold higher, and total antibody titers up to
60-fold higher than unformulated vaccines at the same dose. Vaccines
formulated with even the lowest tested dose of Vaxfectin(TM) yielded
equivalent or better immune responses at the 1 mcg dose than unformulated
vaccines at the 9 mcg dose, confirming the dose-sparing potential of
Vaxfectin(TM). The improved performance of Vaxfectin(TM) in the latest
studies reflected further optimization of the Vaxfectin(TM)/vaccine ratio
at each of three dosing levels tested in mice.
Vaxfectin(TM) was designed by Vical to increase the immune response to
DNA vaccines, and Vaxfectin(TM)-formulated DNA vaccines have demonstrated
good tolerability and adjuvant activity in multiple animal models,
including nonhuman primates. The Fluzone(R) data suggest that Vaxfectin(TM)
could provide a dose-sparing effect with the government-stockpiled H5N1
pandemic influenza vaccine, also produced by sanofi pasteur. Since neither
Fluzone(R) nor the sanofi pasteur H5N1 pandemic influenza vaccine are
formulated with an adjuvant, Vaxfectin(TM) could, if approved, simply be
added to either vaccine prior to administration. Vaxfectin(TM) may have
potential applications as an adjuvant for other protein-based vaccines as
well. The company holds patents in the United States covering Vaxfectin(TM)
and its use with conventional vaccines against infectious diseases and
cancer, and in both the United States and Europe covering the use of
Vaxfectin(TM) with DNA vaccines.
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, including: 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 H5N1 or other strains of avian influenza will emerge as pandemic
threats; whether the company's DNA vaccine candidate will be effective in
protecting humans against H5N1 or other strains of avian influenza; whether
the influenza vaccine or any other product candidates will be shown to be
safe and effective in clinical trials; the timing, nature and cost of
clinical trials; whether Vaxfectin(TM) will provide a dose-sparing effect
with the government-stockpiled H5N1 pandemic influenza vaccine; whether
Vaxfectin(TM) will be used with other protein-based vaccines; whether Vical
or its collaborative partners will seek or gain approval to market the
influenza vaccine or any other product candidates; whether Vical or its
collaborative partners will succeed in marketing the influenza vaccine or
any other product candidates; 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; 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.
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