Edmonton - Isotechnika Inc. has completed recruitment for its Canadian Phase III psoriasis trial for its lead immunosuppressive compound, ISA247. Of the 400 subjects enrolled in the trial, 207 subjects have commenced treatment. The company received a "No Objection Letter" from Health Canada on December 1, 2004 and commenced the trial on December 2, 2004.
The Phase III trial will be performed over a twenty-four week period at thirty-two centres across Canada involving subjects with moderate to severe psoriasis. It will be conducted as a randomized, double-blind study with four dose arms. Of the 400 subjects, 100 subjects will receive the high dose (0.4 mg/kg twice daily), 100 subjects will receive the mid dose (0.3 mg/kg twice daily), 100 subjects will receive the low dose (0.2 mg/kg twice daily) and 100 subjects will receive placebo. Subsequent to the first 12 weeks, those subjects who received placebo will move into the mid dose range dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study.
"We are pleased that our recruitment has been completed in just two months," stated Dr. Randall Yatscoff, Isotechnika's President and CEO. "This indicates an unmet medical need for people suffering from this debilitating disease."
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