Vical H1 Influenza Vaccine Delivers Robust Preclinical Results With 100% Response
SAN DIEGO, June 30, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company's vaccine against A/H1N1 pandemic influenza (swine flu) produced robust immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits after a standard two-dose vaccine regimen. In addition, at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. The company is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.
"Our DNA vaccine technology offers an innovative approach to dealing with pandemics," said Vijay B. Samant, President and Chief Executive Officer of Vical. "The speed of our platform both in development and manufacturing was demonstrated by our rapid completion of vaccine production and successful immunogenicity testing in animals while conventional vaccine manufacturers are still working toward production of their initial supply of H1 vaccine. We are encouraged by these compelling data with our Vaxfectin(r)-formulated DNA vaccine and we look forward to advancing to human clinical trials as soon as possible."
Vical's plasmid DNA vaccine contained the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the A/H1N1 influenza strain selected on April 30. The preclinical vaccine was produced by May 11 and animal testing began on May 15. In two parallel animal studies, one in mice and one in rabbits, vaccine was administered on Day 0 and Day 21, a standard regimen for pandemic influenza vaccines. Sera collected on Day 21, after a single dose of vaccine, showed clear increases over baseline hemagglutination inhibition (HI) titers in 100% of the animals, and HI titers above the protection threshold in 88% of the mice and 75% of the rabbits. Sera collected on Day 35, two weeks after the second dose, showed HI titers well above the protection threshold in 100% of the animals, ranging from 320 to 2,560 (geometric mean titer = 987) in the mice, and from 640 to 2,560 (geometric mean titer = 1,522) in the rabbits. The HI assay measures a vaccine's ability to prevent viruses from binding to cells, and HI titers of 40 or more are accepted as the threshold for potential protection against influenza viruses. The vaccine encoded H1 hemagglutinin from the swine-origin A/California/04/09 wild-type influenza virus. Vical ran the HI assay against the swine-origin A/California/07/09 x-179a reassortant influenza virus obtained from the CDC.
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 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 external funding will be secured to support H1 DNA vaccine development; whether such vaccine will advance to clinical testing; whether results in animals will be predictive of results in humans; whether Vical or others will continue development of any influenza DNA vaccine candidates; whether H1N1 or any other strains of influenza will cause a pandemic; whether HI titers will be predictive of protection against H1N1 influenza; whether the company's DNA vaccine candidate will be effective in protecting humans against 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; 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: Vical Incorporated Alan R. Engbring (858) 646-1127 www.vical.com
