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Ocera Therapeutics Completes First in Human Studies with OCR-002 for the Treatment of Hyperammonemia and Hepatic Encephalopathy
Date:12/15/2010

ortance being placed on accelerating the development of drugs like this in order to reach the patients in need as quickly as possible."  Ocera plans to initiate Phase 2 studies in 2011.

OCR-002 data presented at EASL, AASLD, and ISHEN in 2010 have confirmed that OCR-002 can consistently lower ammonia in multiple preclinical models of cirrhosis and acute liver failure and has been correlated with normalization of intracranial pressure, brain edema and neurologic function.

"OCR-002 is a promising new therapy for the acute care of patients with hyperammonemia and hepatic encephalopathy, a patient population for whom treatment options are currently very limited," stated Dr. Tarek Hassanein, Professor of Medicine and Director of Southern California Liver Centers, Coronado, CA.

About OCR-002

OCR-002 (ornithine phenylacetate) is a novel injectable treatment with a unique mechanism of action that directly reduces toxic levels of ammonia in the blood. When the liver is unable to detoxify ammonia, patients are at risk of developing hepatic encephalopathy, a condition that can lead to coma and death, requiring hospitalization that cost the U.S. healthcare system $1.2 billion every year. The compound has demonstrated in several published studies that it has a rapid and sustained effect in lowering toxic ammonia levels and can prevent severe neurologic complications in animal models of acute liver failure and liver cirrhosis.  Ocera Therapeutics licensed OCR-002 from University College of London in December 2008.

About Hepatic Encephalopathy

Hepatic Encephalopathy (HE) is caused by the accumulation of toxic substances in the bloodstream, including ammonia, that are normally removed by the liver.  HE ranges in severity from disorientation to confusion, coma and even death.  With severe liver impairment, toxic substances such as ammonia accumulate in the blood and impair the function of brain cells.  
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SOURCE Ocera Therapeutics, Inc.
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