TOKYO, Nov. 29 /PRNewswire/ -- Y’s Therapeutics Co., Ltd., a privately held biopharmaceutical company, announced the initiation of 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 (PSGL) and human IgG1. The product 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.
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, 20-50% are believed to develop DGF. There were approximately 10,000 kidney transplants from deceased donors performed in the US in 2004. The underlying cause of DGF is ischemia-reperfusion injury (I/R injury), which happens when blood re-flows into ischemic tissue, in this case the newly transplanted organ. During ischemia reperfusion, P-selectin is present on the activated endothelium (blood vessel walls) and the binding of it to its ligand on the leukocytes is the critical first step in inflammation. YSPSL has been demonstrated in a number of animal models to block this selectin/ligand interaction, thereby preventing tissue damage from inappropriate inflammation. YSPSL has been tested in a large number of patients, demonstrating a clinical safety profile similar to placebo.
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. It has two study parts: an open label dose escalation study, and a randomized, double-blind, placebo-controlled study. “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, University of Tennessee, a lead investigator in the study.
“We are very excited about YSPSL and the initiation of this Phase II clinical program,” said Elizabeth Squiers MD, FACS, Vice President of Clinical and Regulatory Affairs at Y’s. “YSPSL’s success in a variety of animal models in inflammation, thrombosis and intimal hyperplasia makes it an attractive investigational agent for development in many areas.” Y’s will be exploring other indication areas for YSPSL in the future.
About Y’s Therapeutics
Y’s Therapeutics (http://www.ysthera.com) is a privately held biopharmaceutical company engaged in the R&D of antibody therapies and small molecules for the treatment of inflammation-mediated diseases, cancer, and other unmet medical needs. Y’s focuses on the development of preclinical and early-stage clinical projects pursued through research collaborations and in-licensing opportunities from academic institutions and biotech companies. Y’s intends to seek collaborative relationships, including out-licensing of product rights and creation of joint ventures, for late-stage development, manufacturing and commercialization of its portfolio products. The company currently has six projects in its clinical and preclinical pipeline.
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Y’s Therapeutics Co., Ltd.
CONTACT: Hiroko Shibuya of Y’s Therapeutics Co., Ltd. (Tokyo, Japan),+011-81-3-5784-2762, or media.relations@ysthera.com
Web site: http://www.ysthera.com/
