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Alba Therapeutics Corporation Reports Preliminary Phase IIa,Clinical Trial Results for AT-1001 for the Treatment of Celiac,Disease

Announces Plans for Advancing AT-1001 into Later Stage Clinical Trials

BALTIMORE, May 07, 2007 /PRNewswire/ -- Alba Therapeutics Corporation today announced preliminary results from its Phase IIa clinical trial for AT-1001 in subjects with Celiac Disease (CD), an autoimmune disease affecting over 3 million people in the United States. Alba's study, the first Phase IIa trial in CD and the first to assess dosing requirements for AT-1001 in CD, was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 in CD subjects during a 2-week gluten challenge.

The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients who were confirmed biopsy positive for CD and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten during a 14-day period. Four doses of the enteric coated oral formulation of AT-1001, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability (IP) -- a marker of disease state in CD -- as well as patient symptoms and outcomes, measured by two validated tests of gastrointestinal disease outcome: the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI).

    Preliminary analysis revealed the following:


    -- At day 14, IP, as measured by the change in urinary lactulose-to-

       mannitol (LA/MA) ratio, exhibited a dose dependent response.   On day

       21, one week after the final drug dosing and gluten challenge, the dose

       dependent trend continued to statistically significant levels.


    -- The GSRS and PGWBI provided additional efficacy signals that further

       support the IP observations.   Patients on the AT-1001 drug arms

       performed better than those on the gluten/placebo arm.  Analyses

       demonstrated that seve
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