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Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis
Date:5/12/2008

Presentation of Phase 1 Clinical Data of MDX-1100 at Digestive Disease Week

2008

PRINCETON, N.J., May 12 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) announced today that it has initiated the Phase 2 clinical development program of MDX-1100, a fully human monoclonal antibody that targets CXCL10 (also known as IP-10), in ulcerative colitis (UC) and rheumatoid arthritis (RA). MDX-1100 could potentially treat UC and RA by suppressing the inflammatory process characteristic of these diseases.

"Based on positive safety data in Phase 1 studies, we have initiated patient enrollment in Phase 2 studies that are designed to establish proof-of-concept," said Geoffrey M. Nichol, M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We are optimistic about the broad potential of MDX-1100 to address a range of inflammatory diseases."

Patients in the Phase 2 randomized, double-blind, placebo-controlled, multi-center study in UC will be administered MDX-1100 at 10 mg/kg or placebo every 2 weeks for a total of 4 doses. All patients will have active UC and will continue standard UC therapy during the trial. The trial is expected to enroll 106 patients at multiple sites internationally. The primary endpoint of the study is the response rate at 8 weeks. Clinical response is based on the Mayo score, a composite endpoint that assesses stool frequency and the amount of bloody stool per day as recorded in a patient diary, physician global assessment and the assessment of colon mucosal inflammation ascertained by endoscopy.

Patients in the Phase 2 randomized, double-blind, placebo-controlled, multi-center study in RA will be administered MDX-1100 at 10 mg/kg or placebo every 2
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SOURCE Medarex, Inc.
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