21-07-2008: Raptor Pharmaceuticals Corp. announced the execution of a collaboration agreement with the University of California, San Diego ("UCSD") to include a Phase 2a clinical trial to evaluate a delayed-release preparation of cysteamine bitartrate in adolescents diagnosed with Non-Alcoholic Steatohepatitis ("NASH"). NASH is a progressive form of liver disease that accounts for approximately 10% of newly diagnosed cases of chronic liver disease, and ranks as one of the leading causes of cirrhosis of the liver in the U.S.
Under the terms of the Agreement, clinical researchers from UCSD will perform the Phase 2a study at the University's General Clinical Research Center, and Raptor will provide funding and clinical supply of Cysteamine. In March 2008, Raptor acquired an exclusive, worldwide license to certain intellectual property and development rights from UCSD surrounding the use of Cysteamine as a potential treatment for NASH.
A rapid-release form of Cysteamine is currently approved for sale by the U.S. Food and Drug Administration ("FDA") for the treatment of nephropathic cystinosis, a rare, genetic lysosomal storage disease. Raptor is currently developing DR Cysteamine, a proprietary, delayed-release formulation of Cysteamine, designed to improve bioavailability and potentially reduce side effects associated with the presently marketed form.
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