Raptor Pharmaceuticals Doses First Patient in Phase 2b Clinical Trial of DR Cysteamine for ...( NOVATO Calif. June 1 /- Raptor Pharma...)

NOVATO, Calif., June 1 /PRNewswire-FirstCall/ -- Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), today announced that it has dosed the first patient in its Phase 2b clinical trial, conducted in collaboration with the University of California, San Diego ("UCSD"), to evaluate Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") capsules in nephropathic cystinosis ("cystinosis"), a rare genetic lysosomal storage disease. Under Raptor's open Investigational New Drug application ("IND"), UCSD is performing the Raptor-sponsored trial at its General Clinical Research Center.

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The Phase 2b clinical trial will enroll up to six cystinosis patients with a history of good compliance using the currently available immediate-release form of cysteamine bitartrate, the only drug cleared for marketing by the U.S. Food and Drug Administration ("FDA") and European Medicines Agency ("EMEA") to treat cystinosis. The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in patients. Data from the study are expected in the third quarter of 2009. Raptor plans to follow the Phase 2b clinical study with a pivotal, Phase 3 clinical study in cystinosis patients anticipated to commence in the fourth quarter of 2009.

DR Cysteamine is Raptor's proprietary enteric-coated micro-bead formulation of cysteamine bitartrate contained in a gelatin capsule and designed for increased absorption, less frequent dosing and improved tolerability relative to the current standard of care. Published studies have shown that fewer than 25% of patients taking immediate-release cystea
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