SOURCE: Y's Therapeutics

May 02, 2007 08:00 ET

Y's Therapeutics Initiates Phase II Trial With YSPSL in Liver Transplant Patients for Prevention of Ischemic Reperfusion (I/R) Injury

TOKYO and BURLINGAME, CA -- (MARKET WIRE) -- May 2, 2007 --Y's Therapeutics, a privately held biopharmaceutical company, announced the initiation of a Phase II clinical trial of its lead compound, YSPSL, for prevention of ischemic reperfusion injury (I/R) in liver transplant patients. The clinical trial is a randomized, double-blind, placebo-controlled study designed to enroll 12 patients undergoing cadaveric orthotopic liver transplantation at Dumont UCLA Transplant Center, a leading US liver transplant center.

"I/R injury has a huge impact on cadaver liver transplantation," stated Ron Busuttil, M.D., Professor of Surgery and Chief of the Division of Liver and Pancreas Transplantation, UCLA Medical Center and a lead investigator in the study. "Treatment with a compound such as YSPSL, should it be shown to be safe and effective, would be very important for transplant patients, and has the potential of significantly increasing the pool of eligible liver donors," Dr. Busuttil explained.

The UCLA transplant research team, led by Drs. Busuttil and Jerzy Kupiec-Weglinski, has published a large body of animal studies that provided preclinical proof of concept for the utility of YSPSL in the liver transplant indication. Y's Therapeutics recently announced the completion of patient enrollment for its Phase II clinical trial of YSPSL for prevention of delayed graft function (DGF) in kidney transplant patients.

"We have been very pleased to be able to participate in this study as well as the ongoing multi-center clinical trial with YSPSL," stated Dr. Gerry Lipshutz, Assistant Professor of Surgery at UCLA, and the principle investigator at UCLA for the Phase II study with YSPSL for the prevention of delayed graft function in cadaveric renal transplantation.

About I/R Injury in Liver Transplants

There were 6,362 liver transplants from deceased donors performed in 2006 in the US, and nearly 2,000 patients die annually while awaiting a new liver, according to the United Network for Organ Sharing (UNOS), a non-profit, scientific and educational organization that administers the Organ Procurement and Transplantation Network (OPTN). The availability of usable livers is limited by the risk of ischemia/reperfusion (I/R) injury, an inflammatory reaction when blood re-flows into ischemic tissue, i.e., the newly transplanted liver. I/R injury may lead to poor short and long-term graft function and survival of the transplanted liver, which can result in the need for immediate re-transplantation or death. Marginal livers, specifically fatty livers and livers from older donors, are at much higher risk for serious I/R injury and are not commonly used for transplantation. Between 600 and 700 marginal livers are discarded in the US annually. Prevention of I/R injury in liver transplantation, by expanding the donors available for transplantation, could help alleviate the chronic shortage of donor livers.

About YSPSL and I/R Injury

YSPSL is a recombinant molecule resulting from the fusion of P-selectin glycoprotein ligand (PSGL) and human IgG1. During I/R, P-selectin appears on the activated endothelium (blood vessel walls) and its binding to ligands on the leukocytes is the critical first step in inflammation. YSPSL has been demonstrated in a number of animal models including transplant, chronic inflammation and myocardial reperfusion, to block this selectin/ligand interaction, thereby preventing tissue damage from inappropriate inflammation. Administration of YSPSL in animal models of transplantation suggests it may also up-regulate beneficial genes such as heme oxygenase-1 that appear to protect organs from I/R Injury. YSPSL has been tested in several clinical studies in patients, demonstrating a clinical safety profile similar to placebo. YSPSL is an investigational drug and not approved for use in any indication.

About Y's Therapeutics

Y's Therapeutics (http://www.ysthera.com) is a privately held biopharmaceutical company engaged in the R&D of novel therapies 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 is seeking 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 has operations in two locations, Y's Therapeutics Co., Ltd., of Tokyo, Japan, and Y's Therapeutics, Inc., of Burlingame, CA.

NOTE TO EDITORS: "YSPSL (rPSGL-Ig) for the Prevention of Delayed Graft Function (DGF): Preliminary Results of Ongoing Dose Escalation and Efficacy Study" will be an oral presentation at the American Transplant Congress in San Francisco during the "Kidney Immunosuppression: Newest Agents" session, beginning at 4:00 PM Sunday, May 6.

Contact Information

  • Contact U.S.:

    John Wulf
    President, Y's Therapeutics, Inc.
    +1-650-777-7000
    Email Contact

    Contact Japan:

    Yasunori Kusuhara
    Corporate Planning Office
    +81-3-5784-2762
    Email Contact