Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adju...( - Dose-Ranging Trial to Further As...),Health

- Dose-Ranging Trial to Further Assess Feasibility of Dose-sparing and

Single-Dose Vaccination Against H5N1 Flu -

GAITHERSBURG, Md., April 15 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced that it has received approval from the Department of Health and Human Services (HHS) to expand its program to develop an immunostimulant adjuvant patch for use with an injected H5N1 influenza vaccine. This decision was based upon positive clinical data generated in a 500-subject, Phase 1/2 study recently completed by Iomai.

Guided by data from this study, Iomai will begin a Phase 2 dose-ranging study designed to identify the optimum dose of antigen and adjuvant that can be used in a one-dose or two-dose regimen to enhance the immune response to a H5N1 influenza vaccine. As the majority of current approaches to pandemic influenza vaccines require two doses, given 3 or 4 weeks apart, a single-dose strategy would significantly simplify the logistics of a mass vaccination program.

Last month, Iomai announced the results of the first clinical trial of the patch when used with an injectable H5N1 influenza vaccine. That trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai adjuvant 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. A second dose of both vaccine and patch further enhanced immunogenicity; 100 percent of subjects who received two 45-microgram doses of vaccine and two Iomai patches had a measurable immune response, and 94 percent of these subjects had immune responses cons
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