Vical Incorporated
(Nasdaq: VICL) announced the enrollment of the first subject in its
Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA)
pandemic influenza vaccine. The double-blind, placebo-controlled trial will
evaluate safety, tolerability and immune responses in up to 60 healthy
volunteers age 18 to 45 at two U.S. clinical sites.
"We have designed a promising pandemic influenza vaccine and
demonstrated its effectiveness against a highly lethal H5N1 challenge in
ferrets, the best available animal model," said Vijay B. Samant, Vical's
President and Chief Executive Officer, "and we have now begun testing in
humans. The currently stockpiled pandemic influenza vaccines primarily
generate antibody responses against a specific strain, and have a limited
shelf life because they cannot be stored frozen. Our pDNA vaccine is
designed to provide T-cell and antibody immune responses for broad
cross-strain protection, and if frozen, would offer improved storage and
deployment. This trial is also important because it marks the first time in
humans for our Vaxfectin(TM) adjuvant, which has potential applications
with both pDNA vaccines and conventional protein-based vaccines."
Vical's vaccine contains three individual DNA plasmids encoding
consensus sequences of two highly-conserved influenza virus proteins --
nucleoprotein (NP) and ion channel protein (M2) -- plus a hemagglutinin
(HA) surface protein from the H5N1 influenza virus strain,
A/Vietnam/1203/04. The combination is designed to elicit both T-cell and
antibody immune responses against emerging strains of influenza virus that
have the potential to cause a pandemic. A monovalent pDNA vaccine encoding
only the H5 protein will also be tested. Both vaccines are formulated with
the company's Vaxfectin(TM) adjuvant, which has demonstrated effectiveness
with a variety of pDNA vaccines in multiple animal models. It has also
demonstrated dose-sparing and immune-enhancing ability with a conventional
seasonal influenza vaccine in animals.
Pandemic Influenza Vaccine Background
Vical's pandemic influenza program goal is to design a vaccine that can
be developed and manufactured quickly and safely without handling the
infectious organism, provide cross-strain protection, and be stockpiled
longer and in less restrictive conditions than conventional vaccines. Vical
systematically tested prototype vaccines using a range of viral antigens to
determine the optimum combination of conserved and variable targets. The
company then systematically tested different formulations for maximum
efficacy at the lowest possible dose. Initial virus challenge studies at
Vical with Vaxfectin(TM)-formulated vaccines encoding NP, M2 and HA
demonstrated significant protection in mice against H1N1 and H3N2 strains
of human influenza. Subsequent studies at St. Jude Children's Research
Hospital demonstrated complete protection with a single dose of the
trivalent vaccine against a lethal challenge in ferrets with the highly
pathogenic A/Vietnam/1203/04 (H5N1) influenza virus strain. Funding for the
preclinical development was provided under a previously-announced grant
from the National Institutes of Health.
"We are excited to advance our pandemic influenza DNA vaccine program
into initial human testing," said Larry R. Smith, Ph.D., Vical's Vice
President of Vaccine Research, "and to conduct our first human tests with
the novel Vaxfectin(TM) adjuvant, which was designed for pDNA vaccines but
also has demonstrated significant dose-sparing and immune-enhancing results
with the sanofi pasteur trivalent inactivated influenza vaccine in
animals."
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 results in mouse and ferret studies
will be predictive of results in human studies; 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
development of an avian influenza vaccine would lead to development of a
seasonal influenza vaccine; 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 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;
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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