Raptor has completed its phase 3 clinical study of DR Cysteamine in cystinosis patients, with the last enrolled patients completing the protocol in early June, 2011, reports Ted Daley, President of Raptor Pharmaceutical Corp.
The study, which was conducted at 9 clinical sites in the US and Europe, was designed to compare the efficacy of DR Cysteamine dosed every twelve hours to Cystagon dosed every 6 hours, based on white blood cell cystine measurements.
In addition to reducing the dose frequency, DR Cysteamine is designed to reduce side effects that have been associated with cysteamine therapy. Safety and tolerability data was also captured. Data analysis is underway and the company expects to report results later this month.
Patients who completed the phase 3 clinical study were given the opportunity to enroll in a long-term extension study in which they continue to take twice-daily DR Cysteamine. Forty out of 41 patients who completed the phase 3 study elected to enroll in the extension study, and some of these patients have now been treated with DR Cysteamine since August, 2010.
Raptor expects to file for marketing approval in the United States and Europe in early 2012.
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