Drug Development

First human trial for AT-1001 completed; U.S. FDA grants fast-track designation

Published in Medical Letter on the CDC and FDA, November 27th, 2005

Alba Therapeutics Corp. announced successful completion of its first phase I trial for the drug candidate AT-1001 and that the U.S. Food and Drug Administration (FDA) has granted fast track designation to AT-1001 for treatment of Celiac Disease (CD).

"We are pleased to have concluded our first human study of oral AT-1001 and delighted that the FDA has granted fast track status to AT-1001. These two events are important additional milestones in our efforts to help those suffering from CD, a disease for which there is no effective treatment," said Blake Paterson, MD, president and CEO of Alba. Alba plans to begin a proof of concept study demonstrating efficacy of AT-1001...

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Source: Medical Letter on the CDC and FDA (2005-11-27)

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