Vical Begins Phase 1 Trial of DNA Vaccine Against H5N1 Pandemic...( SAN DIEGO Aug. 28 /- Vical Incorp...),Health

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 va
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