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From:
Joel Elias <[log in to unmask]>
Reply To:
Joel Elias <[log in to unmask]>
Date:
Wed, 28 May 2008 11:19:56 -0400
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<<Disclaimer: Verify this information before applying it to your situation.>>

 From FDANews:

http://fdanews.com/newsletter/article?issueId=11622&articleId=107082

"Celiac Trial Results Inconclusive

Alba Therapeutics wrapped up its Phase IIa clinical trial of  
larazotide acetate for the prevention of celiac disease reactivation  
in celiac subjects in remission with some positive lessons but not the  
endpoint it wanted.

The study evaluated the safety, tolerability and efficacy of multiple  
doses of larazotide acetate in 86 subjects who had a confirmed biopsy  
diagnosis for celiac disease and were in compliance with a gluten-free  
diet for at least six months prior to enrollment.

The company said that although the primary study outcome was not  
statistically significant, a great deal was learned about the  
potential effects of larazotide acetate and new information was gained  
about the best way to run a celiac disease clinical trial."

My understanding is that this trial was intended to determine whether  
the drug could prevent the autoimmune reaction in celiacs exposed to  
gluten.

Joel
------------
Joel Elias
www.rochesterceliacs.org

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