Small company gets U.S. go-ahead on bird flu patch

Tue Apr 15, 2008 5:52pm EDT
 
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By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - A small biotechnology company trying to develop needle-free vaccines won a boost to its efforts on Tuesday with U.S. government approval to test a bird flu skin patch on more people.

Iomai's patch is not a vaccine, but rather delivers what is called an adjuvant -- an immune boosting agent that will be delivered along with a vaccine to try to make it work better.

The vote of confidence from the Health and Human Services Department adds impetus to all of the company's projects.

"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," Stanley Erck, president and chief executive officer of Iomai, said in a statement.

HHS, which gave Iomai $128 million to work on the patch last year, said the company could do a phase 2 safety trial -- typically involving a few dozen people to see if a product is safe and whether there is any indication it works.

If a phase 2 trial succeeds, companies can move to phase 3 studies, which are carefully designed to prove a product has the intended effect and are needed for final approval by the U.S. Food and Drug Administration.

Last month, the company reported the skin patch helped boost a bird flu vaccine so well that people appear to be protected by a single dose.

This could help stretch vaccine supply during a pandemic.  Continued...

 
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