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Phase II Clinical Trial Initiated of MDX-010 in Breast Cancer

PRINCETON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced the initiation of a Phase II clinical trial of MDX-010, a fully human anti-CTLA-4 antibody, for patients with metastatic breast cancer.

This multi-center, open-label clinical trial is expected to enroll up to 33 patients with metastatic disease. Patients receive a monthly dose of 3.0 mg/kg of the MDX-010 antibody for up to four treatment cycles and will be followed until disease progression. The study is intended to evaluate tumor and immune responses.

"We believe that MDX-010 has the potential to be a powerful agent in the fight against cancer and have expanded our MDX-010 clinical program to include breast cancer," said Donald L. Drakeman, President and CEO of Medarex.

MDX-010 is currently in multiple Phase II clinical trials to test the product for use in patients with metastatic melanoma, prostate cancer and other cancers. MDX-010 is also being tested in a Phase I clinical trial for HIV.

About MDX-010 and Cancer

MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells that is responsible for suppressing the immune response. Studies in mice have demonstrated that an antibody against CTLA-4 has the potential to strengthen the adaptive immune response against certain tumors, leading to the reduction of and, in some cases, the elimination of well-established tumors. In preclinical research, MDX-010 has been shown to enhance immune responses and prevent tumor growth.

The use of MDX-010 to block CTLA-4 has the potential to enable the immune systems of cancer patients to more effectively fight tumors. Data from Phase I/II studies conducted by Medarex and from an ongoing Phase II study indicate that MDX-010 may induce anti-tumor activity in association with potent immune activation in patients with metastatic melanoma and hormone refractory prostate cancer.

According to the American Cancer Society, other than skin cancer, breast cancer is the most common type of cancer found in American women and is the second leading cause of cancer deaths in women, exceeded only by lung cancer. The American Cancer Society estimates that in 2003 about 211,300 women in the United States will be found to have invasive breast cancer, and about 39,800 will die from the disease.

Source: Medarex, Inc.

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