Isotechnika receives approval from Polish competent authority for pivotal Phase 3 psoriasis clinical trial
EDMONTON, Jun 6, 2007 (Canada NewsWire via COMTEX News Network) --
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www.isotechnika.com
Isotechnika Inc. announced today that the Company received approval from the Polish Competent Authority for participation in the ongoing Phase 3 European/Canadian clinical trial. This trial investigates the use of ISA247 in patients suffering from moderate to severe psoriasis. The Company previously received approval from the German Competent Authority and Health Canada to commence the trial. At present, a total of 283 patients have been enrolled in Germany and Canada.
"The addition of twelve clinical trial sites in Poland allows others to gain experience with ISA247 for the treatment of psoriasis and further broadens our investigator base. Addition of these sites, to the twenty-nine sites already established in Germany and Canada, should facilitate us meeting our expected recruitment timelines for this trial," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "Patient enrolment in Poland is expected to commence immediately."
Phase 3 European/Canadian Trial Design
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The Phase 3 European/Canadian psoriasis trial (ESSENCE) will be performed at forty-one clinical centers in Canada, Germany, and Poland. The 24-week trial is being conducted as a randomized, orally administered placebo and cyclosporine controlled trial. To maximize the benefit to patients enrolled in the placebo group, all patients randomized to the placebo group will receive active treatment with ISA247 beginning after 12 weeks of placebo dosing.
To determine successful completion of the trial, the following efficacy parameters will be measured: Static Physician's Global Assessment (SPGA) scores, Psoriasis Area and Severity Index (PASI) scores. Safety parameters will also be monitored by measuring the prevalence of adverse events, including altered kidney function. |
