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CNW Group | ISOTECHNIKA INC. | Isotechnika announces positive 12 month data from PROMISE trial HOME / FRAN AIS / SITE MAP / ABOUT CNW / CONTACT US / SERVICES OFFERED / ACCESS CNW LOGIN / MOBILE EDMONTON, April 21 /CNW/ - Isotechnika Inc. (TSX:ISA) today announced positive 12 month follow up data from the Phase 2b PROMISE trial evaluating its lead drug, voclosporin, a next generation calcineurin inhibitor, in de novo kidney transplant patients. As a dose ranging study, the Phase 2b trial was successful in meeting the primary endpoint demonstrating non-inferiority in biopsy proven acute rejection (BPAR) episodes as compared to tacrolimus control in all three dose groups at six months. The extended data demonstrates that voclosporin maintained efficacy at 12 months. Voclosporin also demonstrated an improved safety profile versus tacrolimus. This trial was designed to determine the most appropriate dosing strategy for the Phase 3 development programs of voclosporin in kidney transplantation. The extension study provides sufficient data to implement a dosing strategy for Phase 3 designed to provide a better safety profile than tacrolimus while maintaining efficacy at 12 months. Isotechnika is in ongoing discussions with regulatory agencies and potential partners with regards to the planning and implementation of a Phase 3 pivotal trial for voclosporin in kidney transplantation. Physician prescribing practices for transplant patients continue to be heavily influenced by side effect profiles and market research indicates that three significant side effect considerations are renal function, new onset diabetes mellitus after transplant (NODAT) and neurological symptoms. Voclosporin in its anticipated therapeutic range demonstrated less NODAT and neurological symptoms with equivalent renal function. In addition, the pharmacokinetic and pharmacodynamic analysis confirms a strong concentration-effect relationship for voclosporin.