REITERATE DMC REPORTSCombined European/Canadian Phase 3 (ESSENCE) Trial
The first patient was enrolled in ESSENCE trial on December 3, 2006. On July 20, 2007, the Company closed recruitment of the ESSENCE trial at 642 patients. The patient population comprises 231 Canadian patients, 295 patients from Germany and 116 patients from Poland. The ESSENCE trial is currently being performed at a total of 50 centers in Germany, Poland and Canada. It is expected that the final data from this trial will be released in the first quarter of 2009.
On March 31, 2008, the Company announced that an independent data monitoring committee (DMC) met and reviewed the interim data from the ongoing blinded ESSENCE trial. The review included 24-week data from approximately 50% of the patients enrolled in the trial. Based on their review of the safety and efficacy data, the DMC did not raise any concerns that would require a change to the original study design.
This is the first direct comparison trial versus cyclosporine (current European standard of care) in moderate to severe psoriasis.
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MDA REPORT ON LAST QUARTER 08
An independent data monitoring committee (DMC) has met on 4 occasions to review interim data from the ongoing
Phase 3 psoriasis (ESSENCE) trial. Based on these reviews of the safety and efficacy data, the DMC did not raise
any concerns that would require a change to the original study design