Medarex, a biopharmaceutical company, has initiated a Phase Ib clinical trial for MDX-1106, a fully human anti-PD-1 antibody for the treatment of cancer.
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The Phase Ib 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 10mg/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 US.
Geoffrey Nichol, senior vice president of product development at Medarex, said: “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.
“Preliminary results from our single-dose Phase I 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.”
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