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Multidose, Dose-Escalation Phase 2 Trial Initiated With MDX-070 in Prostate Cancer

PRINCETON, N.J., June 23 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced the initiation of a multi-dose, dose-escalation Phase II clinical trial of MDX-070, a fully human antibody to prostate specific membrane antigen (PSMA), for patients with hormone refractory prostate cancer. The Phase II clinical trial is expected to enroll up to 30 patients with prostate cancer. Patients are expected to receive four bi-weekly doses of 1, 5 or 10 mg/kg of MDX-070 and will be assessed for tumor response based on objective tumor response and decrease in prostate specific antigen (PSA) serum levels.

In the single-dose Phase I clinical study in 18 patients with metastatic prostate cancer, the antibody was well-tolerated, and no serious drug-related adverse events were reported.

In addition to developing MDX-070 as a potential single antibody therapeutic agent, Medarex has expanded its MDX-070 program to include a second-generation toxin conjugate program, currently in preclinical development.

"We believe that PSMA is an attractive cancer target for potential antibody therapeutics like MDX-070," said Donald L. Drakeman, President and CEO of Medarex. "We have been encouraged by the preclinical and early clinical data and expect to rapidly develop this program for patients in need."

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 and also on blood vessels in other tumors. Preclinical studies conducted by Medarex suggest that MDX-070 may effectively target and eliminate live prostate tumor cells through immunological pathways that prevent cancer cell proliferation or induce elimination of cancer cells.

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 2004 there will be about 230,110 new cases of prostate cancer in the United States, and about 29,900 men will die of the disease.

Source: Medarex, Inc.

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