Pharmaceutical Business review

Y’s Therapeutics initiates study of kidney transplant drug

YSPSL was developed by Wyeth and was acquired by Y’s Therapeutics from an undisclosed California biotechnology company in June 2005, providing Y’s with an exclusive, worldwide license from Wyeth for development and commercialization. The product is a recombinant molecule resulting from the fusion of P-selectin glycoprotein ligand (PSGL) and human IgG1.

Delayed graft function (DGF) is a dysfunction of the transplanted kidney which would possibly require the patient to go back to dialysis. Of patients who receive cadaveric kidney transplants, 20% to 50% are believed to develop DGF. The underlying cause of DGF is ischemia-reperfusion injury, which happens when blood re-flows into ischemic tissue, in this case the newly transplanted organ.

The clinical program is designed to enroll up to 84 patients at 10 leading US transplant centers to evaluate the safety and efficacy of YSPSL for prevention of DGF in patients undergoing cadaveric kidney transplantation.

“DGF has a huge impact on cadaver transplantation. This kind of therapy, should it be shown to be safe and effective, would be very important for transplant patients,” stated Dr Osama Gaber, professor of surgery at the University of Tennessee and a lead investigator in the study.