LONDON and SAN DIEGO, April 2, 2009 University College London Business PLC (UCLB) and Ocera Therapeutics Inc., a privately held biopharmaceutical company, announced the signing of an exclusive worldwide licensing agreement for UCL-L1V and all assets and technologies related to the compound for the treatment of acute hepatic encephalopathy (AHE).
The compound recently demonstrated that it directly reduces blood levels of ammonia, a highly toxic chemical that builds up during attacks of AHE.
Ocera will develop the licensed compound as its second pipeline compound and refer to it as OCR-002. OCR-002 is a novel injectable for the treatment of AHE in patients with advanced liver cirrhosis and acute liver failure.
The licensing agreement is based on research conducted by the collaborative global research project led by Professor Rajiv Jalan and the Liver Failure Group at the Institute of Hepatology, UCL (University College London). The research includes a study which demonstrated an acute and sustained reduction of systemic ammonia levels as well as decreased intracranial pressure in models of AHE in acute liver failure and cirrhosis. The data was published online in Hepatology in February 2009.
Clinical trials in patients with AHE due to cirrhosis and acute liver failure will be carried out at University College Hospital as well as other centres in 2009 under funding from the Medical Research Council (MRC) in the U.K. Ocera is planning to file an IND in late 2009 and U.S. trials will begin in early 2010.
AHE is a reversible neuropsychiatric abnormality frequently seen as a complication of acute liver failure and cirrhosis. With severe liver impairment, toxic substances such as ammonia that are normally removed by the liver accumulate in the blood and impair the function of brain cells.
Signs of AHE include impaired cognition, uncontrolled movements and decreased levels of consciousness leading to coma.
Cirrhosis, which can cause AHE, occurs due to a variety of causes such as hepatitis B and C infection, alcohol, and fatty liver associated with obesity and diabetes. It is estimated that there are up to 1 million cirrhosis patients in the U.S. Acute liver failure is a life threatening condition in otherwise healthy patients and is most commonly caused by an overdose of paracetamol (acetaminophen in the U.S.).
Other causes include reactions to other drugs, herbs, or acute hepatitis. AHE is one of the common complications of cirrhosis and acute liver failure, and up to150,000 patients are hospitalised in the U.S. each year.
"We are pleased to have licensed this breakthrough treatment for patients hospitalised with acute hepatic encephalopathy," said Dr. Laurent Fischer, President and CEO of Ocera Therapeutics. "By directly reducing blood levels of ammonia, OCR-002 has the potential not only to improve symptoms of encephalopathy but may also help to reverse this life-threatening condition and reduce healthcare costs by minimising a patient's time in intensive care."
"There is a significant unmet clinical need to treat hepatic encephalopathy which affects 40-60 percent of patients with established liver disease," stated Professor Rajiv Jalan M.D. "Unlike UCL-L1V, none of the currently available treatments directly lowers circulating levels of ammonia. The partnership with Ocera is a significant step towards bringing this potentially lifesaving discovery to patients."
Mr. Cengiz Tarhan, Managing Director of UCLB said, "This is a significant deal for UCL Business. I am delighted that Ocera is licensing the technology from us. In Ocera, we have found the perfect development and commercialisation partner. They specialise in liver and gastrointestinal drug development and have a demonstrated track record. I am excited to enter this relationship to tap into their extensive experience to bring this technology to market."
|Contact: Ruth Metcalfe|
University College London