The Regenesis trial is a double-blind, randomized, placebo-controlled Phase IIb clinical trial for Stem Cell Therapeutics’s (SCT) lead program, NTx-265, for the treatment of acute ischemic stroke.
The Regenesis Phase IIb stoke trial will be a multi-site trial projected to enroll 134 patients at approximately 18 Canadian sites. A similar US Phase IIb acute ischemic stroke trial was recently approved by the FDA and is projected to enroll 20-30 patients at three-four enrolling US sites. The Canadian and US Phase IIb clinical stroke studies share similar protocols, safety and efficacy endpoints.
SCT is recruiting patients for the multi-centre, double-blind, placebo-controlled Regenesis Phase IIb stroke study for NTx-265 with primary endpoints of efficacy. Patient enrollment is expected to be complete by the end of 2008 with top-line efficacy data expected to be released before the end of the first quarter of 2009.
Allen Davidoff, vice president of product development at SCT, said: “We hope the Regenesis Phase IIb trial will build upon the promising results from the Betas Phase IIa trial by demonstrating the positive effect that NTx-265 exerts on recovery of visual, motor and cognitive recovery in patients who have suffered moderate to severe acute ischemic stroke.”