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Raptor Pharmaceutical Reports Positive Interim Phase 2a Clinical Data in Non-Alcoholic Steatohepatitis (NASH)
Date:10/12/2009

NOVATO, Calif., Oct. 12 /PRNewswire-FirstCall/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTPD), announced positive findings from the completed treatment phase of its open-label Phase 2a clinical trial of delayed-release cysteamine bitartrate ("DR Cysteamine") in adolescent patients with non-alcoholic steatohepatitis ("NASH"), a progressive form of liver disease believed to affect 2% to 5% of the U.S. population. At the completion of the initial six-month treatment phase, the study achieved the primary endpoint: mean blood levels of alanine aminotransferase ("ALT"), a common biomarker for NASH, were reduced by over 50%. Additionally, over half of the study participants had achieved normalized ALT levels by the end of the treatment phase.

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There are no currently approved drug therapies for NASH, and patients are limited to lifestyle changes such as diet, exercise and weight reduction to manage the disease. DR Cysteamine represents an important potential treatment option for patients with NASH. Although NASH is most common in insulin-resistant obese adults with diabetes and abnormal serum lipid profiles, its prevalence is increasing among juveniles as obesity rates rise within this patient population. Although most patients are asymptomatic and feel healthy, NASH causes decreased liver function and can lead to cirrhosis, liver failure and end-stage liver disease.

Under a collaboration agreement between Raptor and the University of California, San Diego ("UC San Diego"), the open-label Phase 2a trial of a prototype formulation of DR Cysteamine is being conducted at UC San Diego's General Clinical Research Center and entails six months of treatment foll
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SOURCE Raptor Pharmaceutical Corp.
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