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Vical Pandemic Influenza Vaccines Provide Complete Protection in Animal Studies; The Journal of Infectious Diseases Publishes H5N1 Challenge Data Print E-mail
16 Jun 2008

Vical announced today the publication of results demonstrating that pandemic influenza DNA vaccines formulated with the company's patented Vaxfectin(R) adjuvant provided complete protection of mice and ferrets against lethal challenge with a highly pathogenic strain of H5N1 influenza virus

SAN DIEGO, CA, USA | June 16, 2008 | Vical Incorporated (Nasdaq: VICL) announced today the publication of results demonstrating that pandemic influenza DNA vaccines formulated with the company's patented Vaxfectin(R) adjuvant provided complete protection of mice and ferrets against lethal challenge with a highly pathogenic strain of H5N1 influenza virus. The publication of the data in the June 15 issue of The Journal of Infectious Diseases (JID)(1) expands previously reported results supporting human clinical testing of the vaccine candidates.

"We believe DNA vaccines offer significant advantages over conventional approaches," said Vijay B. Samant, Vical's President and Chief Executive Officer. "The publication of our pandemic influenza vaccine animal challenge data in a peer-reviewed scientific journal illustrates the approaches we are currently pursuing in our Phase 1 trial, and we look forward to releasing initial results from this study by August. This trial is also important because it marks the first time in humans for our Vaxfectin(R) adjuvant, which has potential applications with both DNA vaccines and conventional protein- based vaccines."

DNA vaccines can be adapted quickly to target emerging strains of influenza, manufactured in a few weeks in generic fermentation equipment, and stored for extended periods of time.

Highlights of the JID article include:

* A single injection of the company's three-component DNA vaccine provided complete protection from death and disease in ferrets against lethal challenge with the A/Vietnam/1203/04 strain of H5N1 influenza virus.
* The three-component vaccine significantly decreased viral shedding in ferrets. Reducing viral shedding, which is the primary cause of disease transmission, could be critically important in limiting the scope of a pandemic.
* A one-component H5 version of Vical's vaccine provided complete protection from death in mice against lethal challenge with the H5N1 influenza virus. A prior Vical publication showed that one-component H3 or H1 vaccines also provided complete protection from death in mice against lethal challenge with H3N2 or H1N1 strains of influenza virus.

Vical's three-component pandemic influenza DNA vaccine candidate targets two "conserved" and one "variable" influenza virus proteins. Vical's one- component DNA vaccine candidate targets only the variable influenza virus protein.

The company is currently conducting a double-blind, placebo-controlled Phase 1 trial of three-component and one-component Vaxfectin(R)-formulated DNA pandemic influenza vaccines to evaluate safety, tolerability and immune responses in approximately 100 healthy volunteers. Vical has completed enrollment in the Phase 1 trial and expects to release initial results by August.

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 http://www.vical.com.

SOURCE: Vical Incorporated





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