Isotechnika's independent data monitoring committee conducts review

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Isotechnika Inc. announces that an independent data monitoring committee (DMC) has met and reviewed the interim data from the Phase 2b kidney transplant (PROMISE) trial. The review included three month data from approximately 1/3 of the anticipated 332 patients to be enrolled. The DMC has recommended that the trial continue according to the original study design. There were no concerns in this review with regards to the safety or efficacy of ISA247 in this patient population.

"The DMC was formed as a special safeguard to ensure the best interests of the patients participating in this trial," commented Dr. Yatscoff, Isotechnika's president & CEO. "Their independent review of the three month data is consistent with our internal analysis which suggests that ISA247 is safe and efficacious in this patient population."

Following the independent review by the DMC, Isotechnika is set to host an evening symposium at the American Transplant Congress in May.

Forty-one centres across North America have been contracted to perform the trial, including 37 centres in the United States and four centers in Canada. The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months as compared to the tacrolimus control, which is currently the North American leading transplant drug in this class. Additionally, kidney function and other laboratory parameters will be monitored for the duration of the trial.

The overall goal of the trial is to find the most appropriate dose that will result in efficacy (lack of acute rejection) with minimal side effects that are typically seen with other calcineurin inhibitors such as cyclosporine and tacrolimus.

A total of 332 de novo (newly transplanted) kidney transplant patients will be enrolled in this trial. Patients will be placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily compared with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control arm. Patients in all four treatment groups will have their doses adjusted in order to achieve pre-defined blood levels of either ISA247 or tacrolimus. All patients will receive oral treatment of drug (ISA247 or tacrolimus) over a six month period along with other standard immunosuppressive therapies used following transplantation.