Ocera Therapeutics, Inc. Completes Enrollment in FHAST1, a Pivotal Phase 3 Clinical Trial in Fistulizing Crohn...(r ofGastroenterology and Endoscopy at Jo...),Health

Ocera also recently announced the initiation of Phase 2 trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy. AST-120 is an oral agent known to adsorb bile acids, toxins and mediators of inflammation from the gastrointestinal tract with the potential to address multiple gastrointestinal diseases. Ocera in-licensed AST-120 from Kureha Corporation based in Tokyo, Japan. AST-120 is not absorbed in the gut and is marketed in Japan and Korea for chronic kidney disease, where it has been used in more than 200,000 patients.

About FHAST1

Fistula Healing With AST-120 is a double-blind, placebo controlled pivotal Phase 3 trial evaluating the efficacy and safety of AST-120 for eight weeks in 240 patients. The primary efficacy endpoint of the study is the number of patients with at least a 50 percent reduction in the number of draining fistulas at both week four and week eight compared to the baseline. Secondary endpoints include changes in Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI), two markers of disease severity and quality of life. Ocera expects initial data to be released in the first quarter of 2008. Patients treated in the FHAST1 study who respond to therapy are followed up for six months. In addition, patients who did not respond to the initial regimen have the opportunity to switch to the alternate treatment, ensuring that patients randomized to placebo who fail therapy can have access to AST-120.

For information on Ocera Therapeutics sponsored clinical trials, please visit http://www.clinicaltrials.gov. Key word: AST-120.

About Crohn's Disease

Crohn's disease is a chronic disorder that causes inflammation of the digestive tract that most commonly affects the small intestine and/or the colon. Some patients may d
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