More than 20 leading transplant centers in the U.S., Canada and Europe, including Emory University, participated in a Phase II study comparing LEA29Y, also known as BMS-224818, to a similar regimen containing standard therapy with cyclosporine.

Study results showed that six months following kidney transplant, LEA29Y was as effective as standard therapy with cyclosporine in preventing acute rejection. However, LEA29Y-treated patients demonstrated significant improvement in kidney function, blood pressure and total cholesterol levels compared to patients receiving cyclosporine.

"Data from this trial suggests that LEA29Y may have one of the most promising safety and effectiveness profiles of any new immunosuppressive agent tested in the 20 years since the introduction of cyclosporine," said Christian Larsen, MD, DPhil, director of the Emory Transplant Center and a co-investigator.

"Currently available anti-rejection drugs like cyclosporine are non-selective and associated with significant side effects, including kidney toxicity, high blood pressure, and elevated cholesterol," said Flavio Vincenti, MD, of the University of California San Francisco, a study investigator who presented the findings today. "These side effects can contribute to the loss of the transplanted organ over time and negatively impact the patient's quality of life. However, LEA29Y has a unique and more selective way of working that may minimize or avoid many of these problems." A total of 221 kidney transplant patients participated in the study and received either LEA29Y (148 patients) or cyclosporine (73 patients) as part of their maintenance treatment regimen. All patients were also treated with mycophenolate mofetil, corticostero
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Contact: Holly Korschun
hkorsch@emory.edu
404-727-3990
Emory University Health Sciences Center
17-May-2004