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Data Demonstrated Metastatic Melanoma Response to Investigational,Immunotherapy Ipilimumab

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.

Ipilimumab is being developed through a joint partnership between Bristol-Myers Squibb and Medarex. Ipilimumab is currently in Phase III development (under Special Protocol Assessments [SPA] with the U.S. Food and Drug Administration [FDA]) to study its effects on metastatic melanoma alone and in combination with chemotherapy. Ipilimumab also is in Phase I and II development for other types of cancers, including prostate, pancreatic, bladder, lymphoma and leukemia. In December 2006, ipilimumab received Fast Track designation from the FDA for use as a monotherapy in previously treated (second-line) metastatic melanoma patients, as well as in combination with chemotherapy (dacarbazine) in previously untreated (first-line) metastatic melanoma patients. Fast Track designation was also granted for ipilimumab as a second-line treatment in combination with a melanoma-peptide vaccine.

About 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 once the disease has spread beyond the skin to other parts of the body by way of the bloodstream or the lymphatic system (metastatic disease). Melanoma accounts for about three percent of skin cancer cases, but it causes most skin cancer deaths. The American Cancer Society estimates that in 2007 there will be 59,940 new cases of melanoma in the U.S., and about 8,110 people will die of this disease.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilit
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