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

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.



CONTACT:

Bristol-Myers Squibb Company
Media:
Ken Dominski, 609-252-5251
[email protected]
or
Laura Hortas, 609-252-4587
[email protected]
or
Investors:
John Elicker, 609-252-4611
[email protected]

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