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Clinical trial shows drug may offer a new option to prevent rejection of transplanted kidneys

Results of a preliminary study suggest that a treatment called LEA29Y works as well as the standard therapy, cyclosporine, to prevent acute kidney transplant rejection, with less potential for long-term harm to the organ and the patient, and better functioning of the transplanted kidney.

LEA29Y is a new type of drug called a co-stimulatory blocker, which prevents the immune system from attacking the transplanted kidney in a more selective manner than traditional anti-rejection drugs. It blocks one of the two signals needed to activate T-cells, once they recognize the transplanted organ as foreign, but leaves the T-cells intact to fight off infections.

More than 20 transplant centers in the U.S., Canada and Europe, including UCSF Medical Center, participated in the phase II clinical trial comparing LEA29Y, also known as BMS-224818, to a similar anti-rejection regimen containing cyclosporine.

"With further clinical study, this may represent a new option to help prevent acute rejection of transplanted kidneys," said Flavio Vincenti, MD, a principal investigator of the trial, who will present the findings on Monday, May 17, 2004, at the American Transplant Congress in Boston. Vincenti is professor of medicine and surgery at the University of California, San Francisco and UCSF Medical Center.

Results of the study show that six months following kidney transplant, LEA29Y was as effective as cyclosporine in preventing acute kidney rejection. However, LEA29Y-treated patients had better kidney function, blood pressure, and total cholesterol levels at six months compared to cyclosporine-treated patients.

"Currently available anti-rejection drugs like cyclosporine are not as selective as this new agent in blocking the immune system," Vincenti said. "These older drugs prevent rejection very well, but they are associated with toxic side effects, including a reduction in kidney function and elevations in blood pressure and cholesterol. This
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Contact: Janet Basu
jbasu@pubaff.ucsf.edu
415-476-2557
University of California - San Francisco
17-May-2004


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