Millennium starts Ph II trial of LDP-02 in UC

US company Millennium Pharmaceuticals says it has started a Phase IIclinical trial in Canada of LDP-02 for ulcerative colitis. The product is an investigational humanized monoclonal antibody for the treatment of inflammatory bowel diseases, including both ulcerative colitis and Crohn's disease.

This multicenter Phase II trial is a randomized, placebo-controlled, double-blind study and will determine the safety and effectiveness of LDP-02 in patients with UC. A Phase I/II clinical trial is also underway in the USA for UC, and a Phase II trial is ongoing in Canada for the treatment of Crohn's disease.

LDP-02 is being developed in collaboration with Genentech, which holds exclusive worldwide commercialization rights on the product. The Crohn's and Colitis Foundation estimates that up to 1 million Americans have IBD. Although the cause of IBD is unknown, research has shown that the body's inflammatory system contributes to the disease process.