Press release
United Therapeutics Corporation Announces First Transplant in EXPAND Clinical Trial of UKidney in Patients With End-Stage Renal Disease
Ongoing EXPAND Study is the First Clinical Trial to Evaluate Xenotransplantation in End-Stage Renal Disease SILVER SPRING, Md. & RESEARCH TRIANGLE PARK,
About this update from United Therapeutics Corporation
[{"type":"text","content":"\nOngoing EXPAND Study is the First Clinical Trial to Evaluate Xenotransplantation in End-Stage Renal Disease\n\n\n SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR) today announced the first clinical xenotransplantation in its EXPAND study of the UKidney™ in patients with end-stage renal disease (ESRD). The successful transplant operation was performed at NYU Langone Health.\n\n\nUnited Therapeutics’ UKidney is an investigational xenokidney from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient. Four porcine genes are inactivated or “knocked out” to reduce the risk of organ rejection and to moderate organ growth.\n\n\n“The first transplant in this first-of-its-kind study marks a watershed moment for United Therapeutics’ vision to broaden access to transplantable organs,” said Leigh Peterson, Ph.D., Executive Vice President, Product Development and Xenotransplantation at United Therapeutics. “This trial moves us closer to offering ESRD patients an alternative to lifelong dialysis, especially those who are unlikely to receive a kidney from a human donor. Our team is grateful for the collaboration that made this possible, and we remain focused on patient safety and scientific progress as the study continues.”\n\n\n“This achievement marks a transformative moment in transplant medicine. The EXPAND study offers new hope to the thousands of Americans currently on the kidney transplant waiting list, many of whom may not survive long enough to receive a human organ. This milestone brings us closer to a future where xenotransplantation may one day address the critical organ shortage crisis,” said Robert Montgomery, M.D., D.Phil., the H. Leon Pachter, M.D., Professor of Surgery, Chair of the Department of Surgery at the NYU Grossman School of Medicine, and Director of the NYU Langone Transplant Institute, who led the transplant team that performed the first xenotransplantation in the EXPAND study.\n\n\nAbout the Study\n\n\nStudy Design\n\n\nEXPAND (NCT06878560) is a multicenter, open-label, safety and efficacy study and is intended to support a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA). The study is designed as a combin...