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Raptor Pharmaceutical Completes DR Cysteamine Phase 2b Clinical Trial in Cystinosis
Date:11/23/2009

NOVATO, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP), today announced results from a Phase 2b clinical trial of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis"). The trial, conducted at the University of California, San Diego ("UCSD") General Clinical Research Center, evaluated safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in nine cystinosis patients.

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Phase 2b Clinical Trial Highlights:

  • DR Cysteamine demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to immediate-release cysteamine bitartrate.
  • Pharmacokinetic evaluation showed that DR Cysteamine had a terminal half-life more than three times longer than the terminal half-life of immediate-release cysteamine bitartrate capsules.
  • Twice-daily DR Cysteamine may achieve the same pharmacodynamic result while using a daily dose 30% lower than immediate-release cysteamine bitartrate capsules 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 be possibly or probably related to immediate-release cysteamine bitartrate.

Raptor plans to meet with the Food and Drug Administration ("FDA") and European Medicines Agency ("EMEA") to discuss the results of its phase 2b study and its plans for a repeat-do
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