Isotechnika releases positive early results from phase 3 trial for ISA247

By Lisa Kerner

Erie, Pa., March 20 - Isotechnika, Inc. announced preliminary 48-week clinical data from its phase 3 psoriasis and extension trials for its lead immunosuppressive drug, ISA247.

Patients completing the 24-week Canadian phase 3 Spirit trial could choose to continue therapy for an additional 36 weeks or discontinue therapy, according to a company news release.

Isotechnika said the goal of the extension trial is to demonstrate continued therapeutic benefit to psoriasis patients, while gathering long-term safety data.

Those choosing to take part in the extension trial were moved from the 0.2 mg/kg bid (low dose) or 0.4 mg/kg bid (high dose) groups into the 0.3 mg/kg bid (mid dose) group, while those who started in the mid-dose group stayed in the same group.

Data has been received on 193 patients receiving treatment for a total of 48 weeks. Patients previously in the low-dose group experienced an improvement in mean percent decrease in Psoriasis Area and Severity Index (PASI) scores from baseline of 41% to 64% after an additional 24 weeks on the mid dose.

Patients previously in the mid- and high-dose groups remained stable with mean percent decrease from baseline PASI scores of 61% and 66%, respectively after a total of 48 weeks of treatment.

Of the total patient population, nine patients in the Spirit trial and 11 patients in the extension trial showed a clinically significant change in kidney function, the release stated.

There have been no clinically significant changes noted during the extension trial in cholesterol, triglycerides, new onset diabetes and infectious complications.

"We are pleased that the extension data shows continued efficacy and safety of ISA247," president and chief executive officer Dr. Randall Yatscoff said in the release.

"The number of patients experiencing a clinically significant reduction in kidney function is significantly less than with other calcineurin inhibitors such as cyclosporine where the incidence is at least 20%. In addition, the absence of any clinically significant changes in lipids, glucose and blood pressure levels, along with the absence of significant infectious complications, supports the long-term safety of ISA247 administration."

Isotechnika is an Edmonton, Alta., biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics.

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