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Medarex Announces Initiation of Phase 1b Clinical Development Program with MDX-1106 for the Treatment of Cancer
Date:11/24/2008

PRINCETON, N.J., Nov. 24 /PRNewswire-FirstCall/ --Medarex, Inc. (Nasdaq: MEDX) today announced it has initiated a Phase 1b clinical trial for MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody for the treatment of cancer. Studies suggest that the PD-1 signaling pathway may play an important role in tumor evasion and escape from host immune responses and may also promote the persistence of certain chronic viral infections.

The Phase 1b clinical trial is designed to primarily evaluate the safety and tolerability of repeated dosing of MDX-1106 in adult patients with solid tumors and will also provide a preliminary assessment of the anti-tumor activity of multiple doses of MDX-1106 (1, 3 or 10 mg/kg) in these patients. The tumors to be studied include malignant melanoma, renal cell cancer, castrate-resistant prostate cancer and non-small cell lung carcinoma. This open label study is expected to enroll up to 76 patients and will be conducted in multiple sites in the United States.

"We believe that anti-PD-1 antibodies could represent the next stage in immunotherapy with a promising mechanism of action and potential for marked synergy with anti-CTLA4 antibodies," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "Preliminary results from our single-dose Phase 1 study demonstrated an acceptable safety profile and initial evidence of anti-tumor activity in cancer. We look forward to the further development of this novel immunotherapy in cancer and, in a separate clinical trial, hepatitis C."

In May 2005, Ono entered into a collaboration agreement with Medarex to research and develop a fully human anti-PD-1 antibody for the treatment of cancer. The two companies plan to share the costs and responsibilities of researc
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