Title: Vical Expands Clinical
Testing of DNA Vaccine Against H5N1 Pandemic Influenza
Date:
12/6/2007 6:30:00 AM
SAN DIEGO, Dec. 6 /PRNewswire-FirstCall/ -- Vical
Incorporated (Nasdaq: VICL) today 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 http://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, 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.
Contact: Alan R. Engbring (858) 646-1127 Website: http://www.vical.com SOURCE Vical Incorporated -0- 12/06/2007 /CONTACT: Alan R. Engbring of Vical Incorporated, +1-858-646-1127/ /Web site: http://www.vical.com / (VICL) CO: Vical Incorporated ST: California IN: HEA IDC BIO SU: TRI MW-AS -- LATH001 -- 5643 12/06/2007 06:30 EST http://www.prnewswire.com |