Isotechnika Pharma Inc IPHAF

Isotechnika receives approval

[blog]

Isotechnika receives approval from the German Competent Authority for a pivotal Phase III psoriasis clinical trial 09:00 EDT Monday, October 02, 2006 EDMONTON, Oct. 2 /CNW/ - Isotechnika Inc. announced today that the Company received approval from the German Competent Authority to conduct a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis with its lead immunosuppressive drug, ISA247. The Phase III European/Canadian psoriasis trial (ESSENCE trial) will be performed over a 24 week period at a total of thirty-six centers in Germany, Poland and Canada involving a total of 500 patients with moderate to severe psoriasis. The trial will be conducted as a randomized, orally administered placebo and cyclosporine controlled study with 300 patients receiving ISA247 (0.4 mg/kg twice daily), 100 patients receiving cyclosporine (1.5 mg/kg twice daily), and 100 patients receiving placebo. In an effort to maximize the benefit to patients enrolled in the placebo group ISA247 will be administered at a dose of 0.4 mg/kg twice daily following the first 12 weeks. Successful completion of the trial will be determined by the following endpoints; << Primary endpoint - superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SGA) score at 12 weeks in the ISA247 treatment group compared to placebo control. Secondary endpoints ------------------- - non-inferiority of ISA247 compared to cyclosporine control in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score at 12 weeks; - a 75% reduction in the Psoriasis Area and Severity Index (PASI) score at 12 weeks of ISA247 versus placebo; and - maintenance of stable kidney function. >> "Moving our late-stage clinical development plan for ISA247 forward in psoriasis and kidney transplantation continues to be our primary focus," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "Following our first phase III psoriasis trial approval and subsequent completion in Canada, this second phase III approval for moderate to severe psoriasis now allows us the opportunity to expand our trials into Europe. In anticipation of this approval, clinical trial sites have been selected. Patient enrollment will commence later this year."