Ocera Therapeutics (OCRX) Announces Late-Breaker Presentation of OCR-002 Phase 2a Data in ALF; Says All Doses 'Well Tolerated'
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Ocera Therapeutics, Inc. (Nasdaq: OCRX), announced that clinical data from STOP-ALF, a Phase 2a clinical trial to evaluate the Safety and Tolerability of Ornithine Phenylacetate (OCR-002) in patients with Acute Liver Failure, will be presented in the late-breaking poster session at The Liver Meeting® 2016, the 67th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), being held on November 11-15, 2016, in Boston, Massachusetts.
Key findings of this safety study reflected in the abstract include the following:
- No drug-related serious adverse events observed; all doses well-tolerated
- Therapeutic serum levels of phenylacetate (PAA) were achieved at infusion rates of OCR-002 20g/24h
- Therapeutic PAA levels appeared to result in considerable ammonia excretion in urine as phenylacetylglutamine (PAGN), the end product by which PAA clears the neurotoxin ammonia, even in patients with non-oliguric renal failure
“Hyperammonemia can lead to cerebral edema, and remains a significant cause of morbidity and mortality in patients with acute liver failure,” commented William M. Lee, M.D., principal investigator of the study. “We are very excited by the results of this safety trial and hope further studies can be conducted to examine the potential for OCR-002 to help clear the high ammonia levels, and improve the outcome of these patients.”
“We are very pleased this important study has been completed,” said Stan Bukofzer, M.D., Chief Medical Officer of Ocera. “In light of the safety profile and tolerability of OCR-002 in this very ill patient population, we believe it could have potential in the management of Acute Liver Failure.”
Additional details including the presentation abstract can be found on the AASLD website by clicking this link.
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. The study, ClinicalTrials.gov: NCT00518440, was conducted by the Acute Liver Failure Study Group, grant number U-01-58369, an NIH-sponsored network of university tertiary care liver transplant sites, with support and supply of study medication from Ocera.
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