Health Canada allows Isotechnika to continue patients on ISA247 until commercialization
EDMONTON, Jun 7, 2007 (Canada NewsWire via COMTEX News Network) --
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Isotechnika today announced that the Company has received a No Objection Letter from Health Canada for the long term use of ISA247 in patients currently participating in the Canadian arm of the Company's Phase 2b kidney transplant trial.
The No Objection Letter allows patients to remain on ISA247 through to commercialization of the drug and beyond after completion of the 12 month Phase 2b trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. A similar protocol amendment for the long term use of ISA247 has also been submitted to the Food and Drug Administration of the United States.
"We submitted the protocol amendment for the long term use of ISA247 after receiving numerous requests from investigators and patients currently involved in our kidney transplant trial," said Dr. Randall Yatscoff, Isotechnika's President & Chief Executive Officer. Dr. Yatscoff added, "Transplant patients are required to remain on immunosuppressive therapies for the rest of their lives. It is expected that the majority of our patients will choose to continue the use of ISA247. We are excited that our patients have the opportunity to continue on ISA247 which should make a real difference in the quality of their lives."
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.
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. Patients completing the six month trial will be given the option to continue therapy for an additional six months. The objective is to gather long term safety and efficacy data in de novo transplant patients. |
