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Isotechnika Announces Interim Three Month Data from Phase 2b Kidney,Transplant Trial

on seen with ISA247 remains consistent with previous data reported which should facilitate ease of dosing to target concentrations and effect.

"The interim three month data continues to support that all three ISA247 doses are efficacious with very good kidney function in each dose group," stated Dr. Randall Yatscoff, President & CEO of Isotechnika. "Most encouraging is the low rate of acute rejection coupled with an improved safety profile. To date, the Company has enrolled 277 patients of the 332 patients required for this trial. We are also encouraged that 100% of the patients have opted to continue receiving therapy for an additional six months after completing the first six months of the trial."

The management team will provide a review of the Phase 2b kidney transplant trial via a live conference call this morning at 9:00 a.m. ET/7:00 a.m. MT. All interested parties will be able to access the live event (audio only) through the Company's corporate web site at www.isotechnika.com.

North American Phase 2b Kidney Transplant Trial Design

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Forty-two centers across North America have been contracted to perform the trial, including thirty-eight centers 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.


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