Y's Therapeutics has begun a Phase II clinical program of YSPSL for prevention of delayed graft function (DGF) in patients undergoing cadaveric kidney transplantation. YSPSL is a recombinant molecule resulting from the fusion of P-selectin glycoprotein ligand and human IgG1.
DGF is a dysfunction of the transplanted kidney that would possibly require the patient to go back to dialysis. Of patients who receive cadaveric kidney transplants, 20 percent to 50 percent are believed to develop DGF.
The clinical program is designed to enroll up to 84 patients at 10 U.S. transplant centers to evaluate the safety and efficacy of YSPSL for.prevention of DGF in patients undergoing cadaveric kidney transplantation. It has two study parts: an open label dose escalation study, and a randomized, double-blind, placebo-controlled study.