Bristol-Myers Squibb Company announced that belatacept, an investigational selective T cell co-stimulation blocker being studied for use in solid organ transplantation, will be the subject of seven oral clinical presentations related to kidney transplantation at the 23rd International Congress of The Transplantation Society, being held August 15–19, 2010, in Vancouver, British Columbia, Canada. In total, 18 abstracts from company-sponsored studies will be presented during the congress.
Belatacept is currently under review with the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and other health authorities, for use in adult patients receiving kidney transplants. On May 1, 2010, Bristol-Myers Squibb received a complete response letter from the FDA requesting 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The company is working with the FDA to provide that data, as well as answer some requests for information to support the manufacturing of belatacept and the proposed Risk Evaluation and Mitigation Strategy (REMS) programme.
“Bristol-Myers Squibb is pleased to present data, including our two-year Phase 3 data on belatacept, at this international congress,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We are committed to the development of this compound as a potential therapeutic option for kidney transplant patients."
Belatacept is an investigational agent under development by Bristol-Myers Squibb for the prophylaxis of organ rejection in adult patients receiving kidney transplants. The proposed trade name for belatacept is NULOJIX.
Belatacept is a fusion protein designed to be a selective T cell co-stimulation blocker that binds to a specific site on certain cells of the immune system (i.e., antigen presenting cells) to block the second signal necessary to activate T cells, which are the predominate immune mediators of allograft rejection.
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.