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Preliminary Phase 2 Data of Ocera Therapeutics' OCR-002 for the Treatment of Liver Cirrhosis and Upper GI Bleeding Show Potent Ammonia Reduction
Date:5/29/2012

BARCELONA, Spain and SAN DIEGO, May 29, 2012 /PRNewswire/ --- Hospital Universitari Vall d'Hebron Research Institute in Barcelona and Ocera Therapeutics, Inc. announced today preliminary data from an open label phase 2 study evaluating the overall effectiveness and safety of OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis of the liver and upper GI bleeding. An interim analysis of the first cohort of patients demonstrated that OCR-002 is well tolerated and provided a rapid and durable ammonia reduction after 36 hours of treatment. The data were presented at the 15th International Symposium for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) in Grenaa, Denmark.

OCR-002 is a novel injectable agent that removes toxic, circulating ammonia from the blood. In patients with severe liver impairment, ammonia and other toxic substances that are normally removed by the liver accumulate in the blood and impair the function of brain cells. By removing circulating ammonia, OCR-002 may treat or prevent hepatic encephalopathy (HE), a neuropsychiatric complication of acute liver failure associated with increased levels of circulating ammonia. Signs of HE include impaired cognition, uncontrolled movements and decreased levels of consciousness leading to coma and even death.

"These early data demonstrate that OCR-002 is well tolerated, rapidly normalizes hyperammonemia and has the potential to prevent the development of hepatic encephalopathy," said Dr. Juan Cordoba of Hospital Universitari Vall d'Hebron and the lead investigator of the study. "Cirrhosis patients that present with acute upper gastrointestinal bleeding have a 30% chance of developing hepatic encephalopathy and require intensive care. A medicine that can quickly remove the toxic ammonia may help prevent or reverse this life-threatening condition, minimize the need for intensive care and shorten hospitalization."

The data presented today from the study of Upper GI bleed in
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SOURCE Ocera Therapeutics, Inc.
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