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

EDMONTON, May 07, 2007 /PRNewswire-FirstCall/ - Isotechnika Inc. today announced the audited three month results, reviewed by the Data Monitoring Committee, of the first third of the patients treated in its Phase 2b de novo kidney transplant trial for the Company's lead immunosuppressive drug, ISA247.

This interim analysis is based upon the assessment of the first 116 patients enrolled. There have been 28 patients treated with the low dose (0.4 mg/kg twice daily) resulting in 11% incidence of acute rejection; 25 patients treated with the mid dose (0.6 mg/kg twice daily) resulting in 8% incidence of acute rejection; and 29 patients treated with the high dose (0.8 mg/kg twice daily) resulting in 3% incidence of acute rejection, as compared to 34 patients treated with tacrolimus, resulting in 9% incidence of acute rejection. All rejection episodes were appropriately treated. No transplanted kidneys have been lost. When all three of the ISA247 dosing groups are combined, there is a 7% rate of acute rejection in the ISA247 groups compared to a 9% rate of acute rejection in the tacrolimus group, which is being dosed optimally.

As part of the trial, kidney function is being measured on an ongoing basis by Glomerular Filtration Rate (GFR). Based on the data generated to date, very good kidney function has been observed in all of the ISA247 dosing groups. Within the first month post-transplant, kidney function showed improvement across all ISA247 dosing groups similar to that observed in the tacrolimus group. Fewer incidences of hypomagnesemia, neurological side effects, and new onset diabetes mellitus have been observed with all ISA247 dosing groups as compared to tacrolimus. There have been no clinically significant differences noted in blood pressure, lipids (cholesterol and triglycerides) or other laboratory parameters examined to date. Additionally, the strong pharmacokinetic/pharmacodynamic correlati
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