Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protect...( - HHS Now Reviewing Data to Determine...),Health

- HHS Now Reviewing Data to Determine Next Steps in $128 Million Contract -

GAITHERSBURG, Md., March 20 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced positive interim results from the 500-subject Phase 1/2 trial of its immunostimulant adjuvant patch used with an injected vaccine for H5N1 influenza. The trial met a key endpoint, demonstrating a clinically relevant adjuvant effect when the Iomai patch was used with a single dose of the 45-microgram H5N1 vaccine. The trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai 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.

This is one of the first trials to demonstrate that a single dose of pandemic influenza vaccine may meet the level of protection suggested in U.S. Food and Drug Administration guidance, which recommends that a pandemic vaccine achieve immune response levels considered protective in 70 percent or more of vaccine recipients. The trial was conducted under a $14.5 million contract with the U.S. Department of Health and Human Services (HHS) with the potential for an additional $114 million in follow-on funding. Iomai has shared the data with HHS and is now working with them to determine the next steps.

The only FDA-approved vaccine in the United States for the avian influenza H5N1 virus requires two 90-microgram doses, administered 28 days apart, to achieve hemagglutinin inhibition (HI) titers equal to or greater than 40 in 44 percent of vaccinated individuals.

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