Top > News Releases
Y's Therapeutics Completes Phase IIa Trial with YSPSL in Kidney Transplant
Patients for Prevention of Ischemic Reperfusion Injury (IRI)
Tokyo, Japan, and Burlingame, CA – September 15, 2008 -
Y’s Therapeutics, a privately held biopharmaceutical company, announced the completion of a Phase IIa clinical trial
of its lead compound, YSPSL for prevention of IRI in kidney transplant patients. The clinical trial was conducted in
two parts: Part A was an open-labeled dose escalation study in 15 patients, whose results were published in May 2007
at the American Transplant Congress in San Francisco. Part B was a randomized, double-blind, placebo-controlled study
that enrolled 44 patients at 15 US transplant centers. Part B has now been completed, fully analyzed, and a final study
report compiled. In a retrospective analysis on stratified patient sets, YSPSL was shown to significantly improve early
graft function in terms of serum creatinine reduction and increased glomerular filtration rate, specifically in patients
at high risk for renal IRI. YSPSL also reduced expression of IRI biomarkers. These data were presented at the recent XXII
International Congress of the Transplantation Society on August 14, 2008, in Sydney, Australia.
“I am encouraged by the impact of YSPSL on early renal graft function” stated A Osama Gaber, M.D., Director of
Transplantation at the Methodist University Hospital in Houston, TX, lead investigator in the study.
“The YSPSL studies are pioneering and will define the paradigm for clinical development in renal and liver
transplant IRI. IRI has a huge impact on kidney and liver graft function and survival” said E. Steve Woodle, M.D.,
Professor of Surgery and Chief of the Division of Transplantation at the University of Cincinnati, OH, who was another
lead investigator in the study. “YSPSL is safe, and if the current data hold and are expanded in further studies,
YSPSL will be very important for transplant patients, and also has the potential of significantly increasing the pool
of eligible organ donors,” Dr. Woodle explained.
“We are very pleased and encouraged by the beneficial effect of YSPSL on early renal function seen in this study”
stated Masanori Murayama, President and CEO of Y’s Therapeutics: “Though more appropriate prospective binary endpoints
will need to be defined for a coming Phase IIb study, the current data make us very confident that clinical proof of
concept in renal transplant can be obtained through further development based on the lessons learned in the current study”.
YSPSL is currently also being developed in liver transplantation at Dumont-UCLA Transplant Center, and encouraging
preliminary data were presented by the lead investigator Ron W. Busuttil, M.D., on July 9, 2008 at the Annual Meeting of
the International Liver Transplant Society in Paris.
About IRI in Kidney Transplants
There were 10,212 kidney transplants from deceased donors performed in 2006 in the US; and the number of patients on
the waiting list exceeds the number of available kidneys by seven-fold, 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). A large and increasing portion of these organs come from high-risk “extended criteria” and “non
heart-beating donor” kidneys. Kidney allografts from deceased donors and specifically the high-risk organs are highly
predisposed to suffer ischemia/reperfusion (I/R) injury, an inflammatory reaction that occurs when blood re-flows into
ischemic tissue, i.e., the newly transplanted organ. Renal IRI causes slow or delayed graft function (DGF), whose clinical
manifestations range from a slower creatinine reduction through the need for post-transplant dialysis up to primary
non-function and graft loss. In retrospective studies, DGF has been shown to reduce average renal graft survival time
by more than 50%. Prevention of IRI injury in kidney transplantation with YSPSL could thus improve post-operative graft
function and prolong graft survival. Additionally, by expanding the number of donor organs available for transplantation,
YSPSL has the potential to help alleviate the chronic shortage of transplantable kidneys.
About YSPSL and IRI
YSPSL is a recombinant molecule resulting from the fusion of P-selectin glycoprotein ligand (PSGL) and human IgG1.
During IRI, 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 down-regulate proinflammatory biomarkers such as interleukin 6 that promote
inflammation after IRI. 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 therapeutics 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.
Y's Therapeutics Co., Limited (Symbol: Private)
Fujiwara Building, 4F, 1-10-11 Ebisu-Nishi, Shibuya-ku Tokyo
Japan, 150-0021
http://www.ysthera.com
| ◈U.S. CONTACT◈ Scott McNinch Director of Business Development, Y's Therapeutics, Inc. +1-650-777-7029 bizdev@ysthera.com |
◈JAPAN CONTACT◈ Yoshio Hioki Director of IP / Licensing & Planning Department, Y's Therapeutics, Co., Ltd. +81-3-5784-2762 bizdev@ysthera.com |
 |
 |
Top |
Site Map | Access Map | Privacy Policy | Terms of Use |
