Vical awarded contract to conduct Phase 1 clinical trial of Vaxfectin-formulated DNA vaccine against A/H1N1

Mar 22 2010

Vical Incorporated (Nasdaq:VICL) announced today that the U.S. Navy, through the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., has awarded Vical a contract to conduct a Phase 1 clinical trial of the company's Vaxfectin^®-formulated DNA vaccine against A/H1N1 pandemic influenza (swine flu). Vical had previously been awarded a contract by the U.S. Navy, in collaboration with the Transformational Medical Technologies Initiative (TMTI) of the Department of Defense (DoD), to support large-scale cGMP vaccine manufacturing and related clinical and regulatory preparations for the trial, bringing total U.S. government funding for this project to approximately $2 million.

The Investigational New Drug (IND) application describing the trial design had been allowed by the U.S. Food and Drug Administration (FDA) in 2009, so the new funding clears the path for the trial to begin.

"The 2009 outbreaks of H1N1 pandemic influenza provided an excellent opportunity for Vical to demonstrate the speed of our vaccine development approach, particularly in the crucial early weeks," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Our collaborators within the U.S. Navy are focused on developing a more responsive vaccine platform to provide rapid protection for military personnel against future emerging disease threats. The Navy funding of a Phase 1 trial allows us to build on the success of our H5N1 vaccine, expand the safety and immunogenicity database for Vaxfectin^®-formulated vaccines in humans, and open the door to broader collaborations with the U.S. government."

As previously announced, Vical was the first company to produce a vaccine against the A/H1N1 influenza virus after the initial reports of widespread outbreaks in Mexico, and the first to announce robust immunogenicity results from animal testing in two species. The company has opted to advance the H1 DNA vaccine, formulated with Vical's patented Vaxfectin^® adjuvant, only with continued government funding.

Source Vical Incorporated