Ocera Therapeutics, Inc. (NASDAQ:OCRX)

Discussion in 'Men's Economics' started by Michael Scally MD, Apr 5, 2015.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Since being cleared by the DSMB, this might be a play.
    They will need to do a money raise within the year, but that might be waiting for the next read out. Good sign, maybe!

    Ocera Therapeutics, Inc. (NASDAQ:OCRX)

    Ocera's drug candidate, OCR-002, ornithine phenylacetate, is being evaluated for the treatment of hepatic encephalopathy in patients with liver cirrhosis, acute liver injury and acute liver failure, areas of high unmet medical need. OCR-002 is a novel ammonia scavenger which rapidly removes ammonia from the blood. Ammonia is thought to be one of the primary causes of hepatic encephalopathy. OCR-002 is the subject of a Company-sponsored Phase 2b trial and an investigator-sponsored Phase 2a trial. OCR-002 has received Orphan Drug designation in both the U.S. and Europe and has been granted fast track status by the U.S. Food and Drug Administration.

    Ocera Completes Interim Analysis of OCR-002 in Phase 2b STOP-HE Study for the Treatment of Acute Hepatic Encephalopathy. Independent DMC Recommends Continuation of Study.

    PALO ALTO, Calif., April 1, 2015 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced successful completion of a planned interim analysis of its STOP-HE study, a double-blind placebo-controlled study of OCR-002 in patients with acute hepatic encephalopathy (HE). The study's independent Data Monitoring Committee (DMC) reported that the trial is not futile and no drug-related safety signals have been observed in the study. Based on the DMC's recommendation, Ocera will continue the STOP-HE study and will increase target enrollment from 140 patients to approximately 230 patients. The Company remains blinded to data reviewed by the DMC in the interim analysis.