May 5, 2010 (FinancialWire) — Raptor Pharmaceutical Corp. (NASDAQ: RPTP) has received positive Phase 2a clinical trial results from its pilot study of delayed-release cysteamine bitartrate in 11 adolescent patients with non-alcoholic steatohepatitis (NASH), a progressive form of liver disease believed to affect 5% to 11% of the U.S. population.

The results were presented at the Digestive Disease Week 2010 conference in New Orleans, LA on May 2, 2010.

The trial was conducted under a collaboration agreement between Raptor and the University of California, San Diego (UC San Diego) at UC San Diego's General Clinical Research Center. Eligible patients with baseline levels of liver enzymes at least twice normal levels were enrolled to receive twice-daily, escalating oral doses of up to 1,000 mg of delayed-release cysteamine bitartrate for six months, followed by a six-month post-treatment monitoring period.

Patients showed a marked decline in ALT levels during the treatment period with seven of 11 patients achieving a greater than 50% reduction and six of 11 reduced to within normal range. The reduction in liver enzymes was largely sustained during the six-month post-treatment monitoring phase. Other important liver function markers showed positive trends.

NASH is a more aggressive form of NAFLD, and is the most common cause of chronic liver disease in North America. There are no currently approved drug therapies for NASH; patients are limited to lifestyle changes such as diet, exercise and weight reduction to manage the disease.

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