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Investigational transplant drug effectively preserves kidneys while avoiding toxic side effects

Larsen, MD, DPhil, director of the Emory Transplant Center. "The problem is, the medication not only shuts down the immune system, but has side effects that increase the risk of heart attacks and can damage the kidney. We need to develop a medication as effective as cyclosporine in preventing initial rejection, while at the same time preserving the kidney and providing better patient outcomes."

Dr. Larsen and Thomas Pearson, MD, DPhil, with colleagues at Bristol-Myers Squibb Pharmaceutical Research Institute, developed LEA29Y to selectively block the second of two cellular signals (co-stimulatory signals) the body needs to trigger an immune response. Blocking this co-stimulatory signal prevents organ rejection while allowing the body to continue fighting other infections.

Following in vitro studies, during which the researchers observed LEA29Y was 10 times more effective than cyclosporine in blocking the co-stimulatory immune signal, Drs. Larsen and Pearson tested the drug in nonhuman primates and found that it significantly prolonged survival of transplanted kidneys.

"The studies with nonhuman primates were critical because, while we knew the co-stimulatory blocker was effective in vitro, we needed to study it in a living organism," said Dr. Larsen. "The nonhuman primate studies allowed us to take a bold step toward studying this medication in humans to determine if it is a better choice than the current standard of care. Working with nonhuman primates enabled us to expedite the research process by four or five years."

The research team recently completed a phase II clinical study comparing LEA29Y to cyclosporine in human kidney transplant patients. On behalf of investigators from 22 transplant centers worldwide. Dr. Larsen will present results from the phase II study at the annual American Transplant Congress May 20 25 in Seattle. Multiple phase III studies currently are being planned.


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Contact: Lisa Newbern
lmnewbe@emory.edu
404-727-7709
Emory University Health Sciences Center
22-Feb-2005


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