An international team of transplant physicians has shown that the investigational drug belatacept (LEA29Y) preserves transplanted kidney function as effectively as cyclosporine, the drug most commonly used to prevent the immune system from rejecting transplanted organs. At the same time, belatacept avoids many of the toxic side effects that adversely affect kidney function, blood pressure and cholesterol levels of patients undergoing long-term anti-rejection therapy with immunosuppressant drugs.
The findings from a Phase II clinical trial of belatacept, conducted in 218 patients at 22 centers in the U.S., Canada and Europe between March 2001 and December 2003, are published in the August 25 issue of the New England Journal of Medicine. Christian P. Larsen, MD, PhD, director of the Emory Transplant Center and professor of surgery at Emory University School of Medicine, and Flavio Vincenti, MD, of the University of California, San Francisco, are co-lead authors of the article.
"The results of this study on the safety and effectiveness of belatacept were as good as we could hope for from the first trial of this new class of drugs in human transplant recipients," Dr. Larsen said. "This arguably is among the most important new classes of immunosuppressive drugs to be evaluated since cyclosporine was introduced more than 20 years ago."
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