USD 12.5 m Funding for the Development of Intercell's Vaccine Patch System for Pandemic Influenza From U.S. Department of Health and Human Serv...( VIENNA Austria Dec. 11 /- Intercell A...),Health

VIENNA, Austria, Dec. 11 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced the execution of a contract modification with the U.S. Department of Health and Human Services (HHS). The agreement commits additional funding of USD 12.5 m for Intercell's Pandemic Influenza program.

Intercell is developing a Pandemic Influenza Vaccine Patch System that includes an immunostimulant patch administered in conjunction with an injected Pandemic Influenza vaccine (manufactured by Solvay Biologicals, B.V., The Netherlands); the system is designed to enhance the immune response and enable dose sparing of the Pandemic Influenza vaccine.

The actual funding forms part of an HHS contract with potential funding of up to USD 128 m over five years. If successful, Intercell's Pandemic Influenza Vaccine Patch System would have the effect of expanding limited vaccine supplies by allowing fewer or lower doses of the vaccine.

The next Phase II study is expected to start in early 2009 and will be a randomized, blinded study to determine the optimal combination and dose of an injected H5N1 influenza vaccine and the vaccine patch from Intercell. The study will be conducted in the U.S. and is expected to enroll 500 subjects at six study sites.

The initial Phase I/II clinical trial funded under this HHS contract demonstrated that a single 45-microgram dose of an injected H5N1 influenza vaccine, coupled with a single 50-microgram Intercell patch was sufficient to provide an immune response considered protective in 73 percent of those tested: a statistically significant improvement over those who received the H5N1 influenza vaccine alone. The trial was one of the first to demonstrate that a single dose of Pandemic Influenza vaccine may meet the level of protection suggested in U.S. Food and Drug Administration (FDA) guidance.

Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA commented: "T
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