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Phase 3 Clinical Trial Protocol Accepted for MDX-010 in Metastatic Melanoma

PRINCETON, N.J., Aug. 23 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the initiation of a pivotal Phase III clinical trial for MDX-010 in combination with MDX-1379, a gp100 melanoma peptide vaccine, in patients with late stage unresectable metastatic melanoma who have failed or are intolerant to first line therapy. The SPA letter provides a written agreement between Medarex and the FDA concerning the trial design and outlines definitive clinical objectives and data analyses considered necessary to support regulatory approval.

In the planned Phase III trial, approximately 750 patients with previously treated Stage III or Stage IV metastatic melanoma are expected to be enrolled. The patients will be randomized to receive one of three regimens: MDX-010 in combination with MDX-1379, MDX-010 alone or MDX-1379 alone. The randomization will be done on a 3:1:1 basis, with 60%, or approximately 450, of the patients receiving the MDX-010/MDX-1379 antibody/vaccine combination. All patients receiving MDX-010 will receive a dose of three mg/kg every three weeks for up to four doses. Best objective response rate (complete and partial responses) will be used as the basis for an expected initial Biologics License Application (BLA) submission under 21 CFR 601 Subpart E, which provides for early approval based upon a surrogate endpoint in life-threatening or severely debilitating illnesses. Disease progression and survival data will continue to be collected from patients being followed in the Phase III trial. Treatment assignment will be blinded, with oversight by an independent Data Monitoring Committee (DMC). Medarex anticipates that patient enrollment will begin in September at multiple centers within the United States.

"We are very pleased with the successful conclusion of our discussions with the FDA relating to the SPA agreement, and we look forward to initiating the Phase III trial as soon as possible," said Donald L. Drakeman, President and CEO of Medarex. "Late stage metastatic melanoma patients have few treatment options, and we are focusing our efforts on bringing this product to the market to address this unmet medical need."

About MDX-010

MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex believes that the use of MDX-010 to block CTLA-4 also has the potential to enable the immune systems of cancer patients to more effectively fight tumors. In June 2004, MDX-010 received orphan drug designation from the FDA for the treatment of high-risk Stage II, Stage III and Stage IV melanoma.

MDX-010 is also currently in multiple Phase II clinical trials to test the product for other oncology indications, including prostate cancer, breast cancer and renal cancer. Outside of oncology, MDX-010 is also being explored for the treatment of HIV. Further information regarding Medarex's MDX-010 program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).

About MDX-1379

MDX-1379 vaccine consists of two gp100 melanoma peptides. These peptides are part of a protein normally found on melanocytes, or pigmented skin cells, and are also present on melanoma cells. These melanoma peptides are recognized by cytotoxic T cells in melanoma patients that are positive for HLA-A2, a human immune system compatibility antigen that is expressed in approximately half of the melanoma population. Medarex has in-licensed the MDX-1379 vaccine peptides from the National Cancer Institute (NCI).

About Malignant Melanoma

According to the American Cancer Society, cancer of the skin is the most common of all cancers. Melanoma accounts for about 4% of skin cancer cases, but it causes about 80% of skin cancer deaths. The American Cancer Society estimates that in 2004 there will be about 55,100 new cases of melanoma in the US, and approximately 14% of these cases will be diagnosed with late stage metastatic melanoma. In the US, nearly 8,000 people are expected to die of melanoma in 2004. Worldwide there are approximately 132,000 people who are diagnosed with melanoma annually, and approximately 37,000 people are expected to die of the disease each year.

Source: Medarex

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