UCL (University College London) Liver Failure Group Present Two Studies on a Novel Treatment Option (OCR-002) for Complications of Hyperammonemia in Liver Failure at the 60th Annual AASLD Meeting

Wednesday, November 4, 2009 General News
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BOSTON, Nov. 2 UCL Liver Failure Group presented data from two studies with OCR-002 (L-ornithine phenylacetate) that suggest the potential for this novel therapeutic agent to impact multiple aspects of liver disease and its complications. OCR-002 is licensed to Ocera Therapeutics, Inc. of San Diego, California. The data, presented at the 60th annual meeting of the American Association for the Study of Liver Diseases, is comprised of a set of studies evaluating the potential for OCR-002 treatment to reduce ammonia, down-regulate inflammation, lower oxidative stress and reduce portal hypertension in a preclinical model of cirrhosis.

Treatment with OCR-002 resulted in a significant reduction in ammonia, normalization of brain edema, reduction in inflammatory cytokines, and a normalization of eNOS activity in both the brain and the liver of cirrhotic animals. These effects were associated with a significant reduction in portal pressure. These findings suggest a possible role for OCR-002 and ammonia reduction in the mitigation of portal hypertensive complications, including hepatic encephalopathy and variceal bleeding.

"With OCR-002, for the first time, we are able to reduce circulating ammonia levels in a consistent and controlled way which gives us the ability to treat complications of liver disease as well as the ability to better understand the pathophysiology of liver disease and its complications," stated Professor Rajiv Jalan M.D. at the Institute of Hepatology, UCL. This study exploring the role of ammonia on portal hypertension and nitric oxide signaling pathway involved close collaboration with the liver hemodynamics group at UCL led by Dr. Raj Mookerjee.

"OCR-002 demonstrates significant potential as a new treatment for liver disease, and addresses an area of significant unmet medical need that is growing at epidemic rates. We are very pleased to be involved in the development of OCR-002 in collaboration with our partners at UCL," added Scott Harris, M.D. Ocera's Chief Medical Officer.

These two studies, presented at AASLD, are titled, "Reduction in hyperammonemia with L-ornithine phenylacetate (OCR-002) in bile-duct-ligated (BDL) cirrhotic rats restores brain eNOS activity by modulating the DDAH-ADMA pathway" and "Treatment of hyperammonemia with L-ornithine phenylacetate (OCR-002) reduces portal pressure by modulating hepatic NFKB and hepatic eNOS activity in cirrhotic rats."

About OCR-002

Ocera Therapeutics licensed exclusive, worldwide rights for the development and commercialization of OCR-002 (L-ornithine phenylacetate) from University College London Business (UCLB). Ocera Therapeutics is developing OCR-002 as a novel injectable medication for the treatment of Acute Liver Failure and Acute-on-Chronic Liver Disease also known as Acute Hepatic Encephalopathy.

About UCL

Founded in 1826, UCL was the first English university established after Oxford and Cambridge, the first to admit students regardless of race, class, religion or gender, and the first to provide systematic teaching of law, architecture and medicine. UCL was recently ranked 4th in the 2009 THES-QS World University Rankings. UCL alumni include Marie Stopes, Jonathan Dimbleby, Lord Woolf, Alexander Graham Bell, and members of the band Coldplay. UCL currently has over 12,000 undergraduate and 8,000 postgraduate students. Its annual income is over £600 million.

About UCL Business PLC

UCL Business PLC (UCLB) is responsible for commercialising research across all disciplines generated from within UCL and associated organisations. It is primarily responsible for protecting inventions and transacting commercial activity including options, licences and collaborative commercial research. UCLB also has responsibility for creating and spinning-out companies from UCL. UCLB is wholly-owned by UCL and operates as an independent company with its own Board of Directors.

About Ocera Therapeutics, Inc.

Ocera Therapeutics, based in San Diego, California, USA, is a privately held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat acute and chronic liver diseases and a broad range of gastrointestinal disorders. In addition to OCR-002, Ocera is developing AST-120 in mild hepatic encephalopathy (Phase 2b), and irritable bowel syndrome. Ocera has raised $62 million dollars in venture financing from Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Montagu Newhall and InterWest Partners. Additional information on the company can be found at www.oceratherapeutics.com.

UCL Contact: Company Contact: Dr. Chris Williams, Business Manager, Akiko Shibata, VP Business UCL Business PLC Operations +44 20 7679 9000 Ocera Therapeutics, Inc. c.williams@uclb.com + 1 858-436-3902 ashibata@ocerainc.com

SOURCE Ocera Therapeutics, Inc.

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