Top-Line Data Available from Three Ipilimumab Pivotal Trials in Patients with Advanced Metastati...(Initiation of the ipilimumab registratio...),Health

Date:12/10/2007

Initiation of the ipilimumab registrational monotherapy program reviewed under SPA with the FDA was announced in March 2006. Following the March 2006 announcement, enrollment of 487 patients was completed in less than one year and in line with timeline expectations. In December 2006, ipilimumab received Fast Track designation from the FDA for use as a monotherapy in previously treated patients with metastatic melanoma.

About Ipilimumab

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. The absence or presence of CTLA- 4 can augment or suppress the immune system's T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.

Comprehensive Clinical Trial Program for Ipilimumab

Ipilimumab is being developed through a joint partnership between Bristol- Myers Squibb and Medarex. Based on nonclinical and clinical studies showing that antibody blockade of CTLA-4 plays an important role in sustaining an active immune response to fight cancer, Bristol-Myers Squibb and Medarex are pursuing a broad clinical development program with ipilimumab evaluating its potential use in advanced metastatic melanoma, as well as prostate, lung, pancreatic, bladder, breast, lymphoma and leukemia cancers. More than 2,000 patients have been treated with ipilimumab as a monotherapy or in combination with other agents in clinical trials.

For further information about ipilimumab clinical trials, please visit http://www.clinicaltrials.gov.

About Advanced Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. As with many cancers, it is more difficult to treat
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SOURCE Bristol-Myers Squibb Company; Medarex, Inc. Copyright©2007 PR Newswire. All rights reserved

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