drugset / Press release

New Data on Investigational Agent Belatacept in Kidney Transplant Recipients to be Presented at 2011 American Transplant Congress

2011-04-25 · Bristol-Myers Squibb · original bms.com ↗

PRINCETON, N.J.--(BUSINESS WIRE)--New data on belatacept, an investigational selective T cell costimulation blocker being studied for use in renal transplantation by Bristol-Myers Squibb Company (NYSE:BMY), will be presented at the American Transplant Congress April 30 – May 4, 2011 in Philadelphia. In total, 21 abstracts from company-sponsored studies will be presented during the congress, including seven oral presentations related to kidney transplantation. The data being presented highlights the broad clinical program for belatacept, a key compound supporting Bristol-Myers Squibb’s strategy to discover and develop targeted therapies for serious diseases. Key data being presented include: Three-Year Outcomes from BENEFIT: A Phase III Study of Belatacept vs. Cyclosporine in Kidney Transplant Recipients 3-Year Safety Profile of Belatacept in Kidney Transplant Recipients from the BENEFIT and BENEFIT-EXT Studies Renal Function at 2 Years in Kidney Transplant Recipients Switched from Cyclosporine or Tacrolimus to Belatacept: Results from the Long-Term Extension of a Phase II Study Three year Outcomes by Donor Type in Phase III Studies of Belatacept vs. Cyclosporine in Kidney Transplantation (BENEFIT & BENEFIT-EXT) “Transplant patients often face multiple medical challenges following surgery” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “The breadth of Bristol-Myers Squibb’s clinical data on belatacept at the American Transplant Congress demonstrates our ongoing commitment to address the unmet medical needs of patients in the renal transplant community." The full schedule of clinical presentations at the American Transplant Congress is as follows: Oral Presentations: Session Date and Time Presentation Title Lead Author May 1, 2011 4:12 p.m. Room 201 Concurrent Session 13 (4:00 p.m. – 5:30 p.m.) The Clinical Implications of Acute Rejection in Contemporary Kidney Transplantation M. Schnitzler Saint Louis University St. Louis, MO May 2, 2011 2:15 p.m. Room 107 Concurrent Session 34 (2:15 p.m. – 3:45 p.m.) Lymphoproliferative Disorders After Kidney Transplantation: Comparison and Validation in Two Large Registries and Association with Outcomes B. Kasiske Hennepin County Medical Center Minneapolis, MN May 2, 2011 2:39 p.m. Room 201 Concurrent Session 32 (2:15 p.m. – 3:45 p.m.) Renal Function at 2 Years in Kidney Transplant Recipients Switched from Cyclosporine or Tacrolimus to Belatacept: Results from the Long-Term Extension of a Phase II Study J. Grinyó University Hospital of Bellvitge Barcelona, Spain May 2, 2011 2:51 p.m. Room 201 Concurrent Session 32 (2:15 p.m. – 3:45 p.m.) Three-Year Outcomes from BENEFIT: A Phase III Study of Belatacept vs Cyclosporine in Kidney Transplant Recipients F. Vincenti Univ. of California San Francisco, CA May 2, 2011 3:03 p.m. Room 201 Concurrent Session 32 (2:15 p.m. – 3:45 p.m.) 3-Year Safety Profile of Belatacept in Kidney Transplant Recipients from the BENEFIT and BENEFIT-EXT Studies C. Larsen Emory University Atlanta, GA May 2, 2011 3:15 p.m. Room 201 Concurrent Session 32 (2:15 p.m. – 3:45 p.m.) Three year Outcomes by Donor Type in Phase III Studies of Belatacept vs Cyclosporine in Kidney Transplantation (BENEFIT & BENEFITEXT) S. Florman Mount Sinai Medical Center New York, NY May 2, 2011 3:27 p.m. Room 201 Concurrent Session 32 (2:15 p.m. – 3:45 p.m.) Renal Function in Patients Treated with Belatacept- or Cyclosporine-based Regimens at Year 3 in the BENEFIT and BENEFIT-EXT Studies A. Durrbach Bicêtre Hospital, Kremlin Bicêtre, France May 3, 2011 9:30 a.m. Hall C Plenary Session (III) (8:30 a.m. – 10:00 a.m.) Belatacept-based Immunosuppression in De Novo Liver Transplant Recipients: 1-Year Experience from a Phase II Study G. Klintmalm Baylor University Medical Center Dallas, TX Poster Presentations: Session Date and Time Presentation Title Lead Author April 30, 2011 6:00 p.m. Hall B The Economic Implications of Acute Rejection in Contemporary Kidney Transplantation M. Schnitzler Saint Louis University Saint Louis, MO April 30, 2011 6:00 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 789 Poster Board 188 6:00 p.m. – 8:00 p.m. Renal Function and Cost of Medical Care among Commercially Insured Kidney Transplant Recipients S. Bunnapradist UCLA Medical Center Los Angeles, CA May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1088 Poster Board 216 5:30 p.m. – 6:30 p.m. Belatacept Compared with Cyclosporine in Renal Allograft Recipients of Extended Criteria Donor Kidneys: 3-year Outcomes from the Phase III BENEFIT-EXT Trial J. Medina-Pestana Hospital do Rim e Hipertensão Sao Paolo, Brazil May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1087 Poster Board 215 5:30 p.m. – 6:30 p.m. Likelihood of Improving or Sustaining Renal Function over Three Years with Belatacept or CsA: Insights from the BENEFIT Study J. Grinyo Hosp. Universitari De Bellvitge Barcelona, Spain May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1091 Poster Board 219 5:30 p.m. – 6:30 p.m. Three Year Outcomes in Black/African American Kidney Transplant Recipients from the BENEFIT and BENEFIT-EXT Studies S. Florman Mount Sinai Medical Center New York, NY May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1096 Poster Board 224 5:30 p.m. – 6:30 p.m. Rationale for Belatacept Less Intensive Regimen in Renal Transplant Recipients J. Shen Bristol-Myers Squibb Princeton, NJ May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1097 Poster Board 225 5:30 p.m. – 6:30 p.m. Predictable Pharmacokinetics, Pharmacodynamics, and Exposure-response of Belatacept Avert the Need of Therapeutic Drug Monitoring J. Shen Bristol-Myers Squibb Princeton, NJ May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1099 Poster Board 227 5:30 p.m. – 6:30 p.m. Health-Related Quality of Life After Kidney Transplantation: Results from Belatacept Clinical Trials F. Dobbels Katholieke Universiteit Leuven Leuven, Belgium May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1100 Poster Board 228 5:30 p.m. – 6:30 p.m. Patient Reports of Immunosuppressant Related Side-Effects After Kidney Transplantation: Results from the Belatacept Phase III Clinical Trial (BENEFIT) F. Dobbels Katholieke Universiteit Leuven Leuven, Belgium May 1, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1075 Poster Board 203 5:30 p.m. – 6:30 p.m. In vitro studies show that Belatacept does not modulate B cell proliferation or T cell migration across brain microvascular endothelium P. Davies Bristol Myers-Squibb Princeton, NJ May 1, 2011 5:30 p.m. Hall B Expected Median Graft Survival Prediction for Belatacept Phase III Trial Outcomes in Kidney Transplantation M. Schnitzler Saint Louis University Saint Louis, MO May 2, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1175 Poster Board 27 5:30 p.m. – 6:30 p.m. Metabolic syndrome and new onset diabetes after transplant (NODAT): data from the international PORT study B. Kasiske Hennepin County Medical Center Minneapolis, MN May 3, 2011 5:30 p.m. Exhibit Hall B, Pennsylvania Convention Center Publication 1525 Poster Board 99 5:30 p.m. – 6:30 p.m. Belatacept 6-Month Intravenous Toxicity Study in Monkeys H. Haggerty Bristol-Myers Squibb New Brunswick, NJ About Belatacept 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 immune mediators involved in allograft rejection. About Bristol-Myers Squibb 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. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews . Bristol-Myers Squibb CompanyMedia:Ken Dominski, [email protected] Hortas, [email protected]:John Elicker, [email protected]

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