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Ocera Therapeutics, Inc. Completes Enrollment in FHAST1, a Pivotal Phase 3 Clinical Trial in Fistulizing Crohn's Disease
Date:10/8/2007

SAN DIEGO, Oct. 8 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced today that it has completed the patient enrollment of its Phase 3 study in fistulizing Crohn's disease. This pivotal, double-blind, placebo controlled study, FHAST1 (Fistula Healing with AST-120), has been designed to determine the efficacy and safety of oral AST-120 in 240 patients with Crohn's disease suffering from perianal fistulas. Initial data from the trial will be available in the first quarter of 2008.

"We are very pleased to have completed the enrollment in our FHAST1 pivotal trial evaluating AST-120 in a timely manner," stated Laurent Fischer, M.D., President and CEO of Ocera Therapeutics. "We would like to thank our investigators and patients in North America, Europe and Israel for their participation in the study."

Data from a double blind, placebo controlled Japanese study of AST-120 in fistulizing Crohn's disease sponsored by Kureha and presented at the Digestive Disease Week in May 2006 demonstrated that AST-120 significantly reduces draining fistulas compared to placebo.

"Up to one third of patients with Crohn's disease suffer from draining perianal fistulas, a chronic and debilitating condition that significantly affects their quality of life," said Professor Stephen Hanauer, M.D., Director of the Section of Gastroenterology and Nutrition at the University of Chicago and the Principal Investigator in the study. "Despite effective treatments, there is an unmet need for new and well-tolerated oral agents for patients with mild to moderate Crohn's disease who suffer from fistulas."

"We were pleased to participate in this Phase 3 trial evaluating the efficacy and safety of AST-120, a new oral treatment option, in fistulizing Crohn's disease," added Professor Simon Travis, M.D., Clinical Directo
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SOURCE Ocera Therapeutics, Inc.
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