Millennium Pharmaceuticals, Inc (CAMBRIDGE, Massachusetts), a biopharmaceutical company focusing on the therapeutic areas of inflammation and oncology, announced the initiation of human subject dosing in an ulcerative colitis (UC) clinical program designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MLN0002 (a humanized monoclonal antibody that selectively binds to alpha4beta7, a T-cell integrin). MLN0002 is derived from a newly engineered, commercially scalable cell line, and inhibits the migration of T-cells, specifically to the gastrointestinal tract, as demonstrated in nonclinical studies. Increased gut T-cell trafficking is believed to play a role in the pathogenesis of inflammatory bowel diseases (IBDs), including conditions such as UC and Crohn's disease.

The new clinical program for MLN0002 consists of two studies: a phase II dose-ranging trial in UC patients and a phase I study in normal healthy volunteers. These studies follow favorable results from a previous multicenter, double-blinded phase II trial of MLN0002 (derived from an earlier cell line) in 181 patients with mild-to-moderately active UC randomized to receive either MLN0002 or placebo. The study found that the percent of patients achieving a remission as measured by an Ulcerative Colitis Clinical Score (UCCS) and a Modified Barron Score (MBS) of zero or one was significantly higher in the two MLN0002 dose groups as compared with the placebo group. MLN0002 was well tolerated, with serious adverse events mainly related to exacerbations of underlying UC, which occurred in 15% of patients in the treatment group, compared to 10% in the placebo group. Additional studies are planned for MLN002.

MLN0002 is one of only a few novel product candidates being investigated as alternatives to anti-TNF and other immunosuppressive therapies for UC and potentially other IBDs.

—A. Techman

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