Vical Incorporated
Source: Vical Incorporated

Vical Advances H1N1 Pandemic Influenza (Swine Flu) Vaccine

SAN DIEGO, May 21, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that in the two weeks since launching its program to develop a vaccine against H1N1 influenza (swine flu), the company has completed development of a prototype H1 vaccine, produced an initial supply of research-grade material, and initiated immunogenicity testing in animals. Assuming a successful outcome of this testing and a commitment for program-specific external funding, the company is ready to advance directly to large-scale cGMP manufacturing of vaccine for human clinical trials to be conducted by the U.S. Navy.

The company previously announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to advance into clinical testing as quickly as possible a Vaxfectin(r)-formulated H1 DNA vaccine. Vical and the NMRC are actively pursuing funding to support the program.

"The ongoing H1N1 influenza outbreaks remain a focal point of international discussions regarding the need for and feasibility of producing an H1 vaccine," said Vijay B. Samant, Vical's President and Chief Executive Officer. "We have already demonstrated the speed of our technology by producing an H1 vaccine and initiating animal testing while others are still assessing the situation. Vical is uniquely positioned to quickly produce an H1 influenza vaccine, building on our successful completion last year of Phase 1 human trials of our H5 influenza vaccine. Our biggest remaining hurdles are not technological, but financial. We are eager to secure the required financial resources as soon as possible to allow continued development in collaboration with the U.S. Navy, and to make vaccine supplies available before they are needed."

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.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

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 vaccine 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 immunogenicity testing in animals will be successful; whether program-specific external funding will be secured to support development; whether the company's technologies will be successfully applied for the development of a Vaxfectin(r)-formulated H1 DNA vaccine; whether such vaccine will advance to clinical testing quickly, if at all; whether results from Vical's H5 influenza vaccine Phase 1 clinical testing will be predictive of results from clinical testing of an H1 influenza vaccine; whether Vical, NMRC or others will continue development of any 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 strains of influenza; whether any 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.