ISOTECHNIKA ANNOUNCES INTERIM PHASE III PSORIASIS TRIAL RESULTS
Isotechnika announced that the Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247, continues to demonstrate a promising safety and efficacy profile.
The Canadian Phase III Psoriasis (SPIRIT) trial commenced Dec. 2, 2004, and includes a total of 453 patients with stable, moderate-to-severe plaque psoriasis. The trial is currently being conducted at 32 sites over a 24-week period and is the largest of its kind in Canada using an orally administered systemic medication to treat psoriasis.
This randomized, double-blind trial examines the efficacy of three dosing groups of the drug ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg twice daily) compared to placebos, with equal numbers of patients assigned to each of the four treatment groups. Subsequent to the first 12 weeks, patients who received placebos were administered the mid-dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study.
Patients already receiving active treatment (ISA247) remained in their respective dosing groups for the final 12 weeks of the trial.
Based on blinded data from 369 patients treated with either ISA247 or a placebo for at least 12 weeks, the mean decrease in Psoriasis Area and Severity Index (PASI) scores for all four treatment groups combined (including the placebo group) was 38 percent. The blinded data has also indicated a good safety profile. The highest mean change in serum creatinine at 12 weeks in any of the dosing groups was 5.6 percent above baseline, which is within normal analytical and physiological variation. After 12 weeks of treatment, a total of five patients -- which represents less than 2 percent of the 369 patients in the trial -- were withdrawn from the study due to a clinically significant effect on kidney function.