Ocera Therapeutics (OCRX) Completes Enrollment in Phase 2a Study of OCR-002 to Treat Acute Liver Failure
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Ocera Therapeutics, Inc. (NASDAQ: OCRX), today announced completion of enrollment in STOP-ALF, a Phase 2a clinical trial to evaluate the Safety and Tolerability of Ornithine Phenylacetate in patients with Acute Liver Failure. The study was conducted by the Acute Liver Failure Study Group, an NIH-sponsored network of university tertiary care liver transplant sites, with support and supply of study medication from Ocera.
“We are excited to announce the completion of STOP-ALF and to report there were no serious safety issues attributable to study medication observed at any dose level,” said William M. Lee, M.D., principal investigator of the study. “We are currently examining additional safety and tolerability parameters, and pharmacokinetic findings for OCR-002 in these acutely ill patients. A late-breaker abstract of top-line findings has been submitted to the American Association for the Study of Liver Diseases (AASLD) for presentation at “The Liver Meeting®” being held in mid-November.
The Phase 2a study was a multi-center, open-label study, conducted in two cohorts of patients diagnosed with acute liver failure. Patients were treated pursuant to one of four escalating dosing regimens of intravenously-administered OCR-002, an ammonia scavenger, which were advanced only after safety and certain pharmacokinetic data were reviewed. Cohort 1 was comprised of affected patients with minimal renal dysfunction (defined as serum creatinine ≤ 1.5 mg/dL and mean arterial pressure of > 65 mm Hg). Cohort 2 included affected patients with compromised renal function (defined as serum creatinine > 1.5 mg/dL and < 10 mg/dL with mean arterial pressure of > 65 mm Hg). Dose levels within the four regimens ranged from approximately 3.33 g/24h to 20 g/24h for up to 5 treatment days. 36 of 47 patients enrolled are considered evaluable having completed at least 72 hours of treatment.
About Acute Liver Failure (ALF)
Acute liver failure is a rare syndrome with a significant mortality rate affecting an estimated 2,000 previously healthy individuals annually in the U.S. ALF is a rapid deterioration of liver function, often due to acetaminophen and idiosyncratic drug reactions, resulting in the liver’s inability to clear the circulating toxin Ammonia, which can lead to cerebral edema, intracranial hypertension, brainstem herniation and death.
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