U.S. Navy to Fund Vical's H1N1 Pandemic Influenza (Swine Flu) Vaccine
SAN DIEGO, Oct. 1, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the U.S. Navy has awarded a contract for $1.25 million to support large-scale cGMP vaccine manufacturing and related clinical and regulatory preparations, which are already underway, for a Phase 1 clinical trial of the company's vaccine against A/H1N1 pandemic influenza (swine flu). The trial will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the Navy.
"The current threat from H1N1 influenza and the potential for other future pandemics from strains like H5N1 call for a proactive approach to developing new vaccine technologies, such as DNA vaccines, that can be deployed rapidly," said Vijay B. Samant, Vical's President and Chief Executive Officer. "We are pleased with the Navy's vision in funding this important vaccine development program, which can benefit from their experience and capability to advance this program to the next stage."
As previously announced, Vical was the first company to produce a vaccine against the A/H1N1 influenza virus after the initial reports of widespread outbreaks in Mexico, and the first to announce robust immunogenicity results from animal testing in two species. Within days of the outbreaks, the company entered into a Cooperative Research and Development Agreement (CRADA) with NMRC to conduct clinical testing of an H1 DNA vaccine formulated with Vical's patented Vaxfectin(R) adjuvant.
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 U.S. Navy funding, 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 Vical will receive all, if any, of the committed Navy funding; whether the committed funding will be sufficient to initiate a human clinical trial; whether the Navy will provide additional funding as needed to complete a human clinical trial; whether Vical's technologies will be successfully applied under the CRADA for the development of a Vaxfectin(R)-formulated DNA vaccine against H1N1 influenza; 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 the company's DNA vaccine candidate will be effective in protecting humans against H1N1 strains of influenza; whether any vaccines based on novel technologies will be applied for emergency use or future routine immunizations; 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.