Isotechnika Inc announced that the final data obtained from its Phase II study to evaluate its novel immunosuppressive therapy, ISA247, in patients with moderate to severe psoriasis showed positive results and demonstrated that ISA247 is well tolerated and efficacious. The trial results convincingly showed that ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints of the study.

The primary efficacy endpoint for the study was the achievement of a 2 point reduction of patient Static Global Assessment scores from baseline to the end of the treatment period. In the high dose arm of the study, the data showed that 54% of the patients achieved this parameter (p less than 0.0001) as compared to 17% in the low dose group and 0% in the placebo group. One of the secondary efficacy endpoints for the trial was the achievement of a 75% reduction in Psoriasis Area and Severity Index (PASI) patient scores from baseline to the end of the treatment period. In the high dose arm of the study, the data showed that 74% of the patients achieved this parameter (p less than 0.0001) as compared to 18% for the low dose group and 0% in the placebo group. Further, a 50% reduction in PASI scores was observed in 88% of the patients in the high dose group and 40% of the patients in the low dose patient group. These efficacy results were achieved without any significant adverse effect on blood pressure and lipid levels. The mean serum creatinine levels remained within the acceptable reference range indicating normal kidney function was maintained for all dosing groups. No significant adverse events (SAE) were recorded in the trial, which provided further confirmation of drug safety and tolerability.

"We are thrilled with the results of our latest study in psoriasis patients which continue to confirm the increased potency and lower toxicity of ISA247 when compared with other medications in this class," said Dr. Randall Yatscoff, President and COO. "As expected, the data confirms that within a certain dosage range, ISA247 elicits the desired therapeutic response without significant adverse side effects. This trial's promising results, when confirmed in Phase III studies, clearly differentiates ISA247 from other calcineurin inhibitors and medications currently used in the treatment of psoriasis. In addition, the data clearly shows that this compound provides treatment beyond the field of transplantation to other diseases and disorders, opening up new potential markets for ISA247," said Dr. Yatscoff, "But what really excites us is that this drug has the potential to enhance the health and quality of life of psoriasis patients suffering from the debilitating symptoms of this difficult-to-treat condition."

The psoriasis trial was a double-blinded placebo controlled study performed at twelve centers in Canada with 201 patients participating in total. The twelve week study was randomized with 2 patients receiving the high dose of ISA247 (0.75 mg/kg) twice a day, 2 patients receiving the low dose of ISA247 (0.25 mg/kg) twice a day and 1 patient on placebo. At the end of the study, the patients were monitored for an additional six week period. The primary objectives of the trial were to evaluate the efficacy and safety of ISA247 in the treatment of psoriasis.