Title: Vical Begins Phase 1 Trial of DNA Vaccine Against H5N1
Pandemic Influenza Date: 8/28/2007 6:30:00 AM
SAN DIEGO, Aug. 28 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today
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 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 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.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
(858) 646-1127 (619) 849-6007
Website: http://www.vical.com
SOURCE Vical Incorporated
-0- 08/28/2007
/CONTACT: 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/
/Web site: http://www.vical.com/
(VICL)
CO: Vical Incorporated
ST: California
IN: HEA MTC
SU: TRI
SO-ND
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