Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adjuvant Patch
- Dose-Ranging Trial to Further Assess Feasibility of Dose-sparing and Single-Dose Vaccination Against H5N1 Flu -
GAITHERSBURG, Md., April 15 --Iomai Corporation 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 considered protective.
"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "Based on the data from this new Phase 2 study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase 3 trial. Our work would not be possible without the enthusiasm and commitment of HHS throughout the process."
This research is being funded under a $128 million contract awarded by HHS in January 2007. Of this amount, $14.5 million was targeted toward completion of the Phase 1/2 study. Using the results of this trial, Iomai is currently working with HHS to refine the clinical development plan and budget for the new Phase 2 trial going forward.
ABOUT IOMAI CORPORATION
Iomai Corporation discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI, discovered by researchers at the Walter Reed Army Institute of Research, taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent travelers' diarrhea. For more information on Iomai, please visit http://www.iomai.com.
Next pageRussell P. Wilson, Senior Vice President, Chief Financial Officer and General Counsel of Iomai Corporation, +1-301-556-4478, [email protected]; or Brian Reid of WeissComm Partners, Inc., +1-703-402-3626, [email protected], for Iomai Corporation