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www.fdanews.com/articles/72173-medarex-announces-phase-i-trial-of-mdx-1100-to-treat-ulcerative-colitis

Medarex Announces Phase I Trial of MDX-1100 to Treat Ulcerative Colitis

May 11, 2005

Medarex has announced the allowance of an investigational new drug application filed with the FDA to initiate a Phase I clinical trial for MDX-1100, a fully human monoclonal antibody that targets IP-10 (also known as CXCL10), for the treatment of ulcerative colitis.

IP-10 is a chemokine that that is associated with the pathogenesis of multiple inflammatory diseases, including ulcerative colitis. The multicenter, single-dose, dose-escalation Phase I clinical trial is expected to enroll up to 32 patients with ulcerative colitis. The trial is designed to collect safety and initial efficacy data. Subject to patient enrollment, data from the Phase I clinical trial is expected in the second half of 2006.