Medarex Inc has been granted Fast Track designation for MDX-010 in combination with MDX-1379, a melanoma vaccine, for the treatment of previously treated, un-resectable Stage III and Stage IV metastatic melanoma. Medarex is currently conducting a Phase III clinical trial with MDX-010 and MDX-1379 combination therapy in Stage III and IV melanoma at multiple sites within the United States.

"We are pleased that the FDA has recognized the unmet medical need of those who suffer from metastatic melanoma, and we believe that this fast track designation for MDX-010 may be an important step towards bringing this product more rapidly to the market," said Donald L. Drakeman, president and CEO of Medarex.

Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA has determined that the drug or biologic is intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate and expedite the development and review of the application for the approval of the product.

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 tumours. In June 2004, MDX-010 received orphan drug designation from the FDA for the treatment of high risk Stage II, III and IV melanoma. In August 2004, Medarex reached a Special Protocol Assessment (SPA) agreement with the FDA for the initiation of the phase III clinical trial. In addition to the phase III clinical trial in melanoma patients, MDX-010 is currently being studied in a number of phase II clinical trials in other oncology indications, including prostate cancer, breast cancer and renal cancer. An MDX-010 study for the treatment of HIV is also ongoing.

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).

According to the American Cancer Society, cancer of the skin is the most common of all cancers. Melanoma accounts for about 4 per cent of skin cancer cases, but it causes about 80 per cent of skin cancer deaths. Worldwide there are approximately 160,000 people who are diagnosed with melanoma annually, and approximately 40,000 people are expected to die of the disease each year.

Medarex is a biopharmaceutical company focused on the discovery and development of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases.