PRINCETON, N.J., Jan. 6 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate Phase I/II clinical trials of MDX-070, a fully human antibody to PSMA (prostate specific membrane antigen), for metastatic prostate cancer.
The multi-center, dose-escalation Phase I/II study is expected to accrue up to 40 patients with metastatic prostate cancer. The MDX-070 study is intended to evaluate safety and tumor response based on objective tumor response and decreases in prostate specific antigen (PSA) serum levels.
"PSMA is a well-validated and highly attractive target for cancer therapy," said Donald L. Drakeman, President and CEO of Medarex. "And, we look forward to moving MDX-070 rapidly through clinical trials."
About MDX-070
MDX-070 is a fully human antibody that targets PSMA, a cell surface marker that is preferentially expressed on malignant prostate tissues. Preclinical studies using human prostatic cancer cells suggest that MDX-070 may effectively target prostate tumor cells in patients. Medarex recently acquired from Northwest Biotherapeutics, Inc. full therapeutic development and commercialization rights to the MDX-070 antibody. Additionally, Medarex entered into a royalty-free, worldwide, non-exclusive cross-license agreement with Millennium Pharmaceuticals, Inc. for certain patents relating to antibodies against PSMA.
According to the American Cancer Society, other than skin cancer, prostate cancer is the most common type of cancer found in American men and is the second leading cause of cancer deaths in men, exceeded only by lung cancer. The American Cancer Society estimates that in 2003 there will be about 220,900 new cases of prostate cancer in the United States, and about 28,900 men will die of the disease. |
