Raptor Pharmaceutical Reports Positive Interim Phase 2a Clinical Data in Non-Alcoholic Steatohepati...(owed by a six-month post-treatment monit...)

Date:10/12/2009

owed by a six-month post-treatment monitoring period. Eligible patients with baseline ALT and aspartate aminotransferase ("AST") measurements at least twice that of normal levels were enrolled to receive twice-daily, escalating oral doses of up to 1,000 mg of DR Cysteamine. The trial currently has enrolled eleven NASH patients between 11-18 years old. No major adverse events were reported during the six-month treatment phase. Trial subjects continue to be monitored during the six-month post-treatment period currently underway. Full results are being submitted for peer review by Raptor and UC San Diego, and are expected to be presented in 2010.

Joel Lavine, M.D., Ph.D., pediatric gastroenterologist at UC San Diego and principal investigator for the NASH study, stated, "We were encouraged by the results of this study. The degree of ALT and AST reductions are indicative of likely improvements in severity of fatty liver damage. The trial results are consistent with ALT and AST reductions normally seen in patients that achieve at least 10% weight loss, even though study participants did not show a significant change in body mass index. DR Cysteamine appears to be a promising candidate for NASH and we look forward to further analyzing these patients during the post-treatment phase."

Raptor's chief medical officer, Patrice Rioux, M.D., Ph.D., said, "These interim results have established proof-of-concept and support further clinical development of DR Cysteamine in NASH. This is an area of significant unmet need, especially with growing numbers of obese children diagnosed with the disorder. While the clinical hurdle is usually high for studies in children and adolescents, we are satisfied with the long-term safety demonstrated in this age group by the currently-marketed immediate-release cysteamine bitartrate formulation. This safety track record, coupled with our interim Phase 2a efficacy data, gives us a great sense of encouragement as we advance D
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SOURCE Raptor Pharmaceutical Corp. Copyright©2009 PR Newswire. All rights reserved

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