Vical Incorporated (Nasdaq:
VICL) announced the expansion as planned of Phase 1 testing of the
company's Vaxfectin(TM)-formulated plasmid DNA (pDNA) pandemic influenza
vaccine to allow comparison of vaccination with needle and syringe to
vaccination with the Biojector(R) 2000 needle-free injection system. The
Biojector(R) 2000 needle-free injection system has been shown to enhance
the immunogenicity of pDNA vaccines in previous animal studies, and has
demonstrated encouraging safety and immunogenicity data in multiple human
pDNA vaccine studies.
Needle and syringe testing in up to 60 subjects, following successful
completion of initial safety evaluations, is now being tested at the
highest planned dose. Needle-free testing is being conducted in up to 50
subjects at the two highest doses. All tests are double-blind and
placebo-controlled, and are designed to evaluate safety, tolerability and
immune responses.
"In August, we began our first human trial of a vaccine incorporating
the novel Vaxfectin(TM) adjuvant," said Larry R. Smith, Ph.D., Vical's Vice
President of Vaccine Research, "and we have now initiated the first human
testing of a Vaxfectin(TM)-formulated vaccine delivered by needle-free
injection. These advances are crucial steps in developing alternative
vaccines for the prevention of pandemic influenza, and in pursuing
potential future vaccine applications."
Vical's vaccine contains three individual plasmids encoding consensus
sequences of two highly-conserved influenza virus proteins -- nucleoprotein
(NP) and ion channel protein (M2) -- and 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
become 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 conventional seasonal and
pandemic influenza vaccines in animals.
Pandemic Influenza Vaccine Background
Vical's pandemic influenza vaccine 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.
About Vaxfectin(TM)
Vaxfectin(TM) is a novel cationic lipid formulation optimized by Vical
to increase the immune response to pDNA vaccines. Vaxfectin(TM)
formulations have demonstrated safety and adjuvant activity in pDNA vaccine
applications in multiple animal models, including nonhuman primates. In
addition to the influenza studies cited above, studies of pDNA vaccines
against cytomegalovirus and measles have shown enhanced immunogenicity in
rodent and nonhuman primates, respectively. In addition, Vaxfectin(TM) has
demonstrated dose-sparing attributes as an adjuvant for protein-based
influenza 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
development of the Vaxfectin(TM)-formulated pandemic influenza DNA vaccine
candidate; whether needle and syringe delivery or needle-free delivery of
the vaccine will be safe and tolerable, or effective in eliciting immune
responses; whether H5N1 or other strains of avian influenza will emerge as
pandemic threats; whether the Vaxfectin(TM) adjuvant or needle-free
delivery will be applied with other vaccine candidates; whether results
from the pandemic influenza vaccine studies will be predictive of results
in other vaccine applications; whether the company's DNA vaccine candidate
will be effective in protecting humans against H5N1 or other strains of
avian influenza; whether development of a pandemic influenza vaccine would
lead to development of a seasonal influenza vaccine; whether results in
mouse and ferret studies will be predictive of results in human studies;
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 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
vical