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Raptor Pharmaceutical Corp. Announces Publication of Results from Phase 2a Trial of DR Cysteamine for Treatment of Cystinosis
Date:1/11/2010

(<2 nmol half-cystine/mg protein) in subjects with cystinosis. Results also indicated that the prototype DR Cysteamine effectively maintained trough WBC cystine levels within a satisfactory range when patients received approximately 60% of the previous total daily dose of IR Cysteamine.

Dr. Dohil stated, "We are seeking to improve tolerability and reduce dosing frequency requirements of IR Cysteamine which have been documented challenges for cystinosis patients, leading to widely reported instances of poor treatment compliance. We believe the results of the Phase 2a study bring us significantly closer to a potential treatment solution for cystinosis patients. The results from our trial indicate prototype delayed-release cysteamine formulation lead to improved tolerability and efficacy when administered twice-daily and at a lower total daily dose than IR Cysteamine. Based on these results, I believe that Raptor's final DR Cysteamine formulation has the potential to improve compliance and long-term treatment outcomes for cystinosis patients."

Based on these Phase 2a results, Raptor conducted a Phase 2b clinical trial using its final commercial formulation of DR Cysteamine and recently announced the following top-line Phase 2b results: DR Cysteamine demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to IR Cysteamine.

  • Pharmacokinetic evaluation showed that DR Cysteamine had a terminal half-life more than three times longer than the terminal half-life of IR Cysteamine.
  • Twice-daily DR Cysteamine may achieve the same pharmacodynamic result while using a total daily dose 30% lower than IR Cysteamine administered four times daily.
  • No adverse events recorded during the clinical trial were determined by the principal investigator to be possibly or probably related to DR Cysteamine. Nine adverse events recorded in the clinical trial were determined to
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SOURCE Raptor Pharmaceutical Corp.
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