Tuesday, May 26, 2009

U.S. Navy to conduct human clinical trials of H1N1 flu vaccine

Vical Advances H1N1 Pandemic Influenza (Swine Flu) Vaccine

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Vical Incorporated /quotes/comstock/15*!vicl/quotes/nls/vicl (VICL 2.19, +0.06, +2.82%) 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."

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