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Vical Expands Clinical Testing of DNA Vaccine Against H5N1 Pandemic Influenza
Date:12/6/2007

SAN DIEGO, Dec. 6 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced the expansion as planned of Phase 1 testing of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA) pandemic influenza vaccine to allow comparison of vaccination with needle and syringe to vaccination with the Biojector(R) 2000 needle-free injection system. The Biojector(R) 2000 needle-free injection system has been shown to enhance the immunogenicity of pDNA vaccines in previous animal studies, and has demonstrated encouraging safety and immunogenicity data in multiple human pDNA vaccine studies.

Needle and syringe testing in up to 60 subjects, following successful completion of initial safety evaluations, is now being tested at the highest planned dose. Needle-free testing is being conducted in up to 50 subjects at the two highest doses. All tests are double-blind and placebo-controlled, and are designed to evaluate safety, tolerability and immune responses.

"In August, we began our first human trial of a vaccine incorporating the novel Vaxfectin(TM) adjuvant," said Larry R. Smith, Ph.D., Vical's Vice President of Vaccine Research, "and we have now initiated the first human testing of a Vaxfectin(TM)-formulated vaccine delivered by needle-free injection. These advances are crucial steps in developing alternative vaccines for the prevention of pandemic influenza, and in pursuing potential future vaccine applications."

Vical's vaccine contains three individual plasmids encoding consensus sequences of two highly-conserved influenza virus proteins -- nucleoprotein (NP) and ion channel protein (M2) -- and 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 become pandemic. A monovalent pDNA vaccine encoding only the H5 protein will also be tested. Both va
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SOURCE Vical Incorporated
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