reiterate Canadian Phase 3 psoriasisCanadian Phase 3 Trial
The Canadian Phase 3 trial which commenced on December 2, 2004 was designed to investigate voclosporin in patients suffering from moderate to severe psoriasis over a 24-week period. Equal numbers of patients were randomized to one of the four treatment groups. This double blind trial examined the efficacy of 3 dosing groups of voclosporin (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg twice daily) over a 24-week period compared to placebo. Subsequent to the first 12 weeks, those patients who received placebo were administered the mid-dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study. Patients who received active treatment with voclosporin remained in their respective dosing groups for the final 12 weeks of the trial.
The primary endpoint being investigated was the number of patients achieving a 75% decrease in the Psoriasis Area and Severity Index (PASI) score at 12 weeks. Secondary endpoints of the trial included maintenance of stable kidney function and assessment of quality of life.
The Company announced final safety and efficacy data October 5, 2006. A summary of the results is as follows:
Patients have now received continuous treatment with voclosporin for a total of 60 weeks. Over the course of the 24-week Phase 3 trial, patients exhibited a 60% mean improvement in Psoriasis Area and Severity Index (PASI) scores. After an additional 36 weeks of treatment, there was a 54% mean improvement in PASI scores indicating continued therapeutic benefit. This beneficial effect was still observed twelve weeks after discontinuing voclosporin treatment; mean PASI scores remained at 35% below pre-treatment scores.
Subsequent to 60 weeks of continuous treatment, there were no clinically significant changes in kidney function, cholesterol, triglycerides, new onset diabetes, infectious complications
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bottom line, this drug works