Vical and U.S. Navy to Expedite Development of H1N1 Pandemic Influenza (Swine Flu) Vaccine
SAN DIEGO, May 6, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company has entered into a Cooperative Research and Development Agreement (CRADA(i)) with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, for the expedited development of a vaccine against the potentially pandemic H1N1 strain of influenza virus. The goal of the collaborative development program is to rapidly advance a Vaxfectin(r)-formulated H1N1 DNA vaccine into clinical testing as quickly as possible. Vical would be responsible for securing regulatory approval of the vaccine for use in the United States and other countries.
"The rapid spread and potential impact of H1N1 influenza have led to a U.S. government declaration of a health care emergency and a World Health Organization (WHO) declaration of a Phase 5 pandemic alert," said Vijay B. Samant, Vical's President and Chief Executive Officer. "We believe our technology is particularly well-suited to emerging infectious diseases like H1N1 influenza for which conventional vaccine technologies are too slow in both development and manufacturing. The successful completion of Phase 1 human trials of our Vaxfectin(r)-formulated DNA vaccines against H5N1 pandemic influenza last year positions us to pursue rapid development of a vaccine to address the threat of an influenza pandemic. We are pleased to collaborate with the U.S. Navy on this H1N1 vaccine development mission."
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 www.vical.com.
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This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the Vical/NMRC CRADA, Vical's DNA vaccine and Vaxfectin(r) adjuvant technologies and their potential application in a vaccine against H1N1 influenza, potential human clinical testing of such a vaccine, as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether external funding will become available to support development under the CRADA; whether the company's technologies will be successfully applied under the CRADA for the development of a Vaxfectin(r)-formulated DNA vaccine against H1N1 influenza; whether such vaccine will advance to clinical testing quickly, if at all; whether results from Vical's H5N1 pandemic influenza vaccine Phase 1 clinical testing will be predictive of results from clinical testing of an H1N1 pandemic influenza vaccine; whether Vical, NMRC or others will continue development of any pandemic influenza DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA before achievement of its objectives; whether H1N1 or any other strains of influenza will cause a pandemic; whether the company's DNA vaccine candidate will be effective in protecting humans against H5N1, H1N1, or any other pandemic strains of influenza; 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 any product candidates; whether Vical or its collaborative partners will succeed in marketing any 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.
(i) NCRADA - NMR-09-3208
CONTACT: Vical Incorporated
Alan R. Engbring
(858) 646-1127
www.vical.com
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