Isotechnika receives approval to participation in Phase 3 European/Canadian clinical trial

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Isotechnika Inc. announces that it has 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 12 clinical trial sites in Poland allows others to gain experience with ISA247 for the treatment of psoriasis and further broadens our investigator base," said Dr. Randall Yatscoff, Isotechnika's president and CEO. "Addition of these sites, to the 29 sites already established in Germany and Canada, should facilitate us meeting our expected recruitment timelines for this trial. Patient enrollment in Poland is expected to commence immediately," said Yatscoff.

The Phase 3 European/Canadian psoriasis trial (ESSENCE) will be performed at 41 clinical centres 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.

The Edmonton-based company is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments while offering therapeutic choices to clinicians.