BURLINGAME, Calif., July 20 /PRNewswire/ -- Y's Therapeutics, Inc. said today that the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) have granted Orphan Drug Designation and Orphan Medicinal Product Designation, respectively, for its investigational drug YSPSL (rPSGL-Ig) in the prevention of graft dysfunction in kidney transplantation.
"This is an important milestone for Y's Therapeutics," stated John Wulf, President of Y's Therapeutics, Inc. "Orphan status for YSPSL's lead indication of Delayed Graft Function (DGF) in kidney transplant patients will assist the YSPSL development and commercialization program. Upon regulatory approval, this status will provide market exclusivity for YSPSL in Europe for ten years and for seven years in the United States for this indication."
In Europe in 2005, more than 17,000 kidney transplant operations took place, while approximately 16,500 patients received transplants in the U.S. during the same period, according to the International Registry of Organ Donation and Transplantation. Transplants from non-living donors -- over 9,900 in the U.S. last year -- are particularly prone to DGF. The underlying cause of DGF is ischemia-reperfusion injury, which occurs when blood flow is restored to cells that have been previously deprived of oxygen and nutrients. The resulting inflammation worsens the damage and can result in poor organ function, rejection and earlier graft loss.
YSPSL (rPSGL-Ig) is a promising clinical-stage recombinant molecule resulting from fusion of P-selectin glycoprotein ligand-1 (PSGL-1) to human IgG1. It is currently under evaluation for the prophylaxis of DGF following kidney transplantation. YSPSL blocks a class of adhesion molecules known as selectins and prevents the accumulation of both leukocytes and platelets at sites of inflammation. Specifically, it binds to selectins expressed on activated platelets and endothelial cells. Consequently, YSPSL inhibits binding of inflammatory cells bearing selectin ligands as well as subsequent inflammatory activity, platelet coagulation and thrombosis. Administration of YSPSL in animal models of transplantation suggests it may also upregulate anti-apoptotic genes such as hemoxygenase-1 that protect organs from ischemia- reperfusion injury.
YSPSL has completed extensive Phase I testing and evaluation in Phase II studies. A Phase II study in DGF was initiated in November 2005, and is currently enrolling patients in 14 major transplant centers in the U.S. The trial is being managed by CTI, a full service specialty CRO with particular expertise in transplantation clinical trials.
Y's Therapeutics (www.ysthera.com ) is a privately held biopharmaceutical company engaged in the R&D of novel therapeutics for the treatment of inflammation-mediated diseases, cancer and other unmet medical needs. Y's focuses on the development of preclinical and 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 several projects in its clinical and preclinical pipeline.
Y's Therapeutics, Inc.
CONTACT: John Wulf, COO/CBO of Y's Therapeutics Co., Ltd., and Presidentof Y's Therapeutics, Inc., +1-650-777-7000, or firstname.lastname@example.org