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The Iomai patch, which contains a powerful immune-stimulating adjuvant, isused in conjunction with an injected influenza vaccine and may generate animmune response with small amounts of vaccine antigen. If successful, Iomai'sapproach may expand the pandemic influenza vaccine supply in the event of aninfluenza pandemic. This clinical trial is funded through an advanceddevelopment contract from the U.S. Department of Health and Human Services.
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"This is the first human trial of the Iomai immunostimulant patch for usewith a pandemic-like influenza vaccine, and the results of this study willgive us crucial information about the ability of the patch to extend thevaccine supply in the event of a pandemic," said Stanley C. Erck, presidentand chief executive officer of Iomai. "Our patch is designed to solve thepressing problem of inadequate pandemic vaccine stocks, and we believe theresults of this trial will validate our unique and flexible dose-sparingapproach."
The study will enroll as many as 500 subjects, who will receive either aplacebo injection or one of three dosages of pandemic influenza vaccine.Patients will receive a booster shot of placebo or vaccine 21 days later. Ofthese patients, approximately one-third will receive no immunostimulant patch,one-third will receive a patch only with the booster shot, and one-third willreceive a patch with both vaccine injections. Subjects will be followed forsafety, and immune responses to the pandemic vaccine will be evaluated.
Existing pandemic influenza vaccine manufacturing capacity is limitedpresently, and research to date suggests that the amount of vaccine antigenrequired to generate a protective effect is far higher than the amount ofvaccine needed for protection from seasonal influenza. While development ofadjuvants -- compounds that increase the body's immune response to vaccines -has accelerated in recent years, existing efforts have focused on combiningadjuvant with antigen in a single shot. Iomai is unique in developing a patch-based adjuvant that may be used with any manufacturer's vaccine.
About Iomai Corporation
Iomai Corporation discovers and develops vaccines and immune systemstimulants, delivered via a novel, needle-free technology calledtranscutaneous immunization (TCI). TCI taps into the unique benefits of amajor group of antigen-presenting cells found in the outer layers of the skin(Langerhans cells) to generate an enhanced immune response. Iomai isleveraging TCI to enhance the efficacy of existing vaccines, develop newvaccines that are viable only through transcutaneous administration and expandthe global vaccine market. Iomai currently has four product candidates indevelopment: three targeting influenza and pandemic flu and one to preventtravelers' diarrhea. For more information on Iomai, please visithttp://www.iomai.com.
Some matters discussed in this press release constitute "forward-lookingstatements" that involve known and unknown risks and uncertainties that couldcause actual results to differ materially from those expressed or implied bythe forward-looking statements. Such forward-looking statements includestatements about the timing and size of enrollment of volunteers for the trialdescribed in this press release, Iomai's ability to obtain information fromthis trial sufficient to assess the safety and dose-sparing capability of itsimmunostimulant patch, ability of Iomai's immunostimulant patch to extend thepandemic flu vaccine supply, attributes of Iomai's immunostimulant patch to beused with any manufacturer's vaccine, and the role of Iomai's immunostimulantpatch in
