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Under Raptor's open investigational new drug application, University of California, San Diego is performing the Raptor-sponsored trial at its General Clinical Research Center.
The Phase IIb 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 FDA and European Medicines Agency to treat cystinosis.
The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of delayed-release (DR) Cysteamine in patients. Data from the study are expected in the third quarter of 2009. Raptor plans to follow the Phase IIb clinical study with a pivotal, Phase III clinical study in cystinosis patients anticipated to commence in the fourth quarter of 2009.
Patrice Rioux, chief medical officer of Raptor, said: "We are pleased that enrollment is now underway in our Phase IIb clinical trial in cystinosis. This is an underserved patient population and there is a compelling need for an improved treatment option. Many patients are unable to take adequate levels of the drug to halt the progression of their disease, which gradually destroys the organs in the body.
"We believe DR Cysteamine could have positive effects on the long-term health of cystinosis patients as well as the quality of life for patients, their families and caregivers."
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