LYCOS RETRIEVER 
Alba: At-1001
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BALTIMORE, Sept. 21 /PRNewswire/ -- Alba Therapeutics Corp. today announced that it had dosed its first patient in a Phase II trial for the treatment of Celiac Disease (CD). In October of last year, the FDA granted "Fast Track" designation to AT-1001, an orally administered zonulin receptor antagonist for treatment of Celiac Disease.
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Alba and Shire will form a joint development committee to monitor R&D activities of AT-1001. Alba will fund all development until AT-1001 has completed Proof of Concept, which is expected to be in the first half of 2009, after which Shire and Alba will share equally development costs under a joint development plan.
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SHPGY TSX:SHQ, to jointly develop AT-1001, Alba's lead inhibitor of barrier dysfunction in various gastrointestinal ("GI") disorders. Shire will receive rights to commercialize all forms of AT-1001 outside of the United States and Japan. Alba will retain all rights to commercialize AT-1001 in the United States and Japan.
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"We are pleased with the rapid enrollment of this study and look forward to reporting its results later this year," said Dr. Blake Paterson, CEO of Alba. "Previously reported AT-1001 clinical trial data has been promising and we expect that the results of our ongoing clinical evaluation will support our Phase IIb trial design." The 86 patients enrolled in the Phase IIa study 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 jluten for a 14 day period.
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SHPGY TSX:SHQ, the global specialty biopharmaceutical company, today announces that it has acquired the worldwide rights, excluding the U.S. and Japan, to AT-1001 from Alba Therapeutics Corporation (Alba). AT-1001 is Alba's lead inhibitor of barrier dysfunction in various gastrointestinal disorders that is currently in Phase 2 development for the treatment of Celiac disease. Shire has acquired rights to all uses for AT-1001, which may ... be studied for the treatment of Crohn's disease and other indications.
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