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Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in Non-Alcoholic Steatohepatitis (NASH)
Date:10/20/2008

Commences Patient Dosing of Delayed-ReleaseCysteamine in Collaboration with UC, San Diego

NOVATO, Calif., Oct. 20 /PRNewswire-FirstCall/ -- Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), today announced the initiation of patient dosing in a Phase 2a clinical trial, in collaboration with the University of California, San Diego ("UCSD"), to evaluate cysteamine bitartrate ("cysteamine") in adolescents diagnosed with Non-alcoholic Steatohepatitis ("NASH"). NASH, a progressive form of liver disease that accounts for approximately 10% of newly diagnosed cases of chronic liver disease, is one of the leading causes of cirrhosis in the U.S.

(Logo: http://www.newscom.com/cgi-bin/prnh/20071022/NYM074LOGO )

Under a previously announced collaboration agreement between Raptor and UCSD to evaluate the safety and potential efficacy of cysteamine in NASH patients, UCSD is performing the Phase 2a open-label clinical study at UCSD's General Clinical Research Center while Raptor is providing funding and clinical supplies of cysteamine. The trial is expected to enroll 12 adolescent NASH patients who have been managing the disease through diet and exercise. Positive data could provide the rationale for later stage clinical studies of cysteamine in NASH patients.

Cysteamine is currently cleared for market by the U.S. Food and Drug Administration ("FDA") and European Medicines Agency ("EMEA") to treat nephropathic cystinosis ("cystinosis"), a rare and genetic lysosomal storage disease. Raptor is developing cysteamine and a delayed release form of cysteamine ("DR Cysteamine") for a number of new potential therapeutic indications, including NASH, under licenses acquired from UCSD. Cysteamine has demonstrated potential efficacy in preclinical and clinical studies in NASH, Huntington's Disease, Batten Disease and other indications.


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SOURCE Raptor Pharmaceuticals Corp.
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