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Ocera Therapeutics, Inc. (OCRX) Announces Enrollment Of The First Patient In A Phase 2b Study For Treatment Of Acute Hepatic Encephalopathy


1/9/2014 10:04:04 AM

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PALO ALTO, Calif., Jan. 8, 2014 (GLOBE NEWSWIRE) -- Ocera Therapeutics (Nasdaq:OCRX) today announced enrollment of the first patient in its multi-center Phase 2b study, the "STOP-HE" or OCR002-HE209 trial. This study is evaluating the efficacy, safety and pharmacokinetics of OCR-002, or ornithine phenylacetate, in hospitalized patients with liver cirrhosis and an acute episode of hepatic encephalopathy (HE). HE is a serious complication of liver failure and decompensated cirrhosis in the setting of chronic liver disease, where elevation of ammonia concentration in the blood and brain can lead to deterioration of neurocognitive function, ranging from subtle abnormalities to frank (overt) disorientation, stupor, coma and death. OCR-002 is a novel molecule, an ammonia scavenger which is intended to rapidly reduce the concentration of ammonia in the blood when administered as a continuous intravenous infusion. OCR-002 has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant HE in patients with acute liver failure or acute on chronic liver disease.

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