Isotechnika’s Receives Recommendation for Continuation of PROMISE Trial
Isotechnika announced that an independent data monitoring committee has reviewed the three-month data from the ongoing Phase IIb kidney transplant PROMISE trial and recommended that the trial continue as currently designed.
Forty-two centers across North America have been contracted to perform the trial, including 38 centers in the U.S. and four centers in Canada.
The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection episodes in patients receiving ISA247 for six months as compared with the tacrolimus control, which is currently the market leader in North American for transplant drugs called calcineurin inhibitors, Isotechnika said.
A total of 334 patients who have recently had kidney transplants have been enrolled in this trial. Patients will be placed into one of four separate treatment groups: three different dose groups of ISA247 (0.4, 0.6 and 0.8 mg/kg twice daily) and a tacrolimus control arm (0.05 mg/kg twice daily).
All patients will receive oral dosing with ISA247 or tacrolimus over a six-month period along with other standard immunosuppressive therapies used following transplantation, the company said.