A new phase II trial starting

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A new phase II trial starting

Postby dignan » Mon Jul 11, 2005 7:30 am

Millennium Initiates Phase II Clinical Trial in Patients With Multiple Sclerosis

July 11 - PRNewswire-FirstCall - Millennium Pharmaceuticals, Inc. today announced the initiation of a multicenter phase II clinical trial of MLN1202 in approximately 40 patients with relapsing-remitting multiple sclerosis (MS), the most common form of the disease. MLN1202, a novel humanized monoclonal antibody, is designed to block CCR2 chemokine receptors and prevent the infiltration of immune cells into inflammatory sites. The CCR2 chemokine pathway is believed to play a central role in a number of inflammatory conditions, including MS.

This proof-of-concept study will assess the safety and tolerability of the molecule and determine the effect of MLN1202 on disease activity by magnetic resonance imaging (MRI). Study participants will receive multiple doses of MLN1202 in two dosing regimens over the course of four months. The study will be conducted at sites in Canada and Europe.

"MLN1202 is designed to specifically target the CCR2 receptors found primarily on monocytes and macrophages -- versus all leukocytes -- which may be beneficial in lowering the risk of systemic immune suppression," said Nancy Simonian, M.D., senior vice president, clinical, regulatory and medical affairs, Millennium. "MS remains a significant area of unmet medical need and we are hopeful that the novel mechanism of action of MLN1202 could provide patients with a new treatment option."

About MLN1202
MLN1202 specifically targets CCR2 chemokine receptors found on the surface of a specific subset of leukocyte: macrophages and monocytes. A number of published preclinical studies suggest that chemokine receptors -- such as CCR2 -- play an important role in the inflammatory response, particularly the trafficking of monocytes and macrophages in both normal and pathological states. The expression of these chemokines and their receptors is increased during the acute phase of MS in humans as well as in animal models of MS. As a result, chemokines have become an emerging focus for research into novel therapeutics for MS.

Currently, Millennium is evaluating MLN1202 in a multi-center phase II clinical trial involving approximately 30 patients with rheumatoid arthritis. The first three cohorts have been fully enrolled and MLN1202 appears to be well tolerated with favorable pharmacokinetic and pharmacodynamic profiles. A fourth cohort has been added with data anticipated in 2006. Additional studies of MLN1202 are planned in atherosclerosis and scleroderma.

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