Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in Non-Alcoholic Steatohepati... (Ted Daley President of Raptor's clinical...)

Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in Non-Alcoholic Steatohepatitis (NASH)

Date:10/20/2008

Ted Daley, President of Raptor's clinical division stated, "We are pleased that dosing is now underway in the Phase 2a clinical trial in NASH, a disease that may have a severe impact on the long-term health of a large number of people. Cysteamine represents an exciting potential treatment for NASH patients currently limited to diet and exercise for disease management. The NASH program is part of our strategy to leverage cysteamine's known safety profile and potential efficacy in several indications where it has already shown promise in clinical and preclinical studies."

Joel Lavine, M.D., Ph.D., pediatric gastroenterologist at UCSD and principal investigator for the NASH study, commented, "The initiation of patient dosing in the NASH trial offers the opportunity to evaluate a potential new treatment for this disorder. We're pleased to collaborate with Raptor for this study as we work to find a treatment for NASH."

NASH is believed to affect 2% to 5% of the U.S. population. While commonly diagnosed in insulin-resistant obese adults with diabetes and abnormal serum lipid profiles, NASH can also occur in children, elderly and non-diabetic persons of average weight. Though most people with NASH feel healthy and show no outward signs of liver disease, NASH causes decreased liver function and potentially leads to cirrhosis, liver failure and end-stage liver disease. In more severe cases, the progressive nature of NASH may require liver transplantation in affected patients.

About Cysteamine and DR Cysteamine

Cysteamine is cleared for market by the FDA and EMEA to treat cystinosis, a rare and genetic lysosomal storage disease. The drug's potential to accumulate in the liver may create a targeted treatment effect for patients with NASH. DR Cysteamine is designed as an enterically coated, oral formulation of cysteamine.

Raptor obtained an exclusive, worldwide license to DR Cysteamine, as well as orphan drug designation from the FDA for DR Cy
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