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The Acute Liver Failure Study Group Initiates Phase 2a Study of OCR-002 for Treatment of Acute Liver Failure after Acetaminophen Overdose
Date:11/8/2012

SAN DIEGO, Nov. 8, 2012 /PRNewswire/ -- Ocera Therapeutics, Inc. announced that the first patient has enrolled in a Phase 2a study to evaluate the safety and tolerability of OCR-002 (ornithine phenylacetate) in the treatment of patients with acute liver injury (ALI) as well as those that have progressed to acute liver failure (ALF) following acetaminophen overdose.

OCR-002 is an investigational drug designed to directly reduce circulating blood levels of ammonia which, at high levels, is neurotoxic, associated with brain injury, and may lead to hepatic encephalopathy and mortality. The investigator-sponsored study, referred to as STOP-ALF, is being conducted by The Acute Liver Failure Study Group, a National Institutes of Health-funded consortium led by UT Southwestern Medical Center.

"When a patient presents with acute liver failure, physicians have no medicines available that can directly lower circulating levels of ammonia, which drive hepatic encephalopathy and can lead to coma and death," stated William M. Lee, M.D., Lead Investigator, and Professor, Internal Medicine, UT Southwestern.  "OCR-002 acts specifically by scavenging for and removing ammonia from the blood, which may prevent the development of hepatic encephalopathy in patients at risk. Our collaboration to study OCR-002 is a key step towards understanding more about a potentially lifesaving drug."

The STOP-ALF study is a Phase 2a multi-center, open-label study that will enroll 24 participants with severe acute liver injury or acute liver failure. The primary endpoint will be safety and tolerability. Secondary endpoints include measurement of OCR-002 plasma concentration, change in venous ammonia and neurological function.

Hepatic encephalopathy is an often-reversible neuropsychiatric abnormality observed in patients with acute liver failure; it is marked by a worsening of brain function when the liver is no longer able to remove toxic substances such as ammo
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SOURCE Ocera Therapeutics, Inc.
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