Healthcare Industry News: Methotrexate
News Release - November 28, 2006
Millennium Initiates Phase II Trial to Evaluate MLN3897 in Rheumatoid ArthritisPart of broad and novel inflammation pipeline
CAMBRIDGE, Mass., Nov. 28 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today announced the initiation of a randomized, double-blind, placebo-controlled Phase II study of MLN3897 in patients with rheumatoid arthritis (RA). MLN3897, an oral, small molecule designed to block CCR1, is a chemokine receptor believed to play a role in a number of inflammatory disorders including RA. MLN3897 is part of the Company's broad inflammation program that includes several product candidates.
"Although many patients with RA initially respond to standard disease-modifying antirheumatic drugs such as Methotrexate or anti-tumor necrosis factor drugs to some degree, up to 70 percent ultimately have an inadequate response," said Nancy Simonian, M.D., Senior Vice President, Clinical, Medical and Regulatory Affairs, Millennium. "Our hope for MLN3897 is to provide patients with a new and innovative therapy for treating this debilitating disease."
The multicenter study will assess the efficacy, safety and tolerability of MLN3897 in combination with Methotrexate (MTX), a standard therapy for RA. Up to 186 patients with RA will be enrolled in the study and must have been taking MTX for a minimum of six months prior to screening. Patients will continue the MTX regimen and will be randomized to receive MLN3897 or placebo. The primary endpoint of the study is ACR20 response rate, a standard clinical measurement for RA, which measures improvement in the number of tender and swollen joints and various levels of disease activity.
MLN3897 is part of Millennium's larger inflammatory development program that includes six product candidates and is one of several small molecules included in the Company's small molecule inflammation collaboration with sanofi-aventis. MLN3897 (sanofi-aventis AVE9897) is an orally active, small molecule antagonist of CCR1, a chemokine receptor found on the surface of various cells in the immune system and involved in a number of inflammatory disorders. In the Phase I studies, results showed MLN3897 to be well-tolerated and to exhibit dose dependent blockage of the CCR1 receptor. Since CCR1 is involved in the recruitment of white blood cells in response to sites of inflammation, effectively blocking CCR1 could have a significant effect on RA disease progression and other inflammatory diseases.
About Rheumatoid Arthritis
RA is a chronic, progressive, inflammatory disease of the articular joints that results in significant pain, stiffness and swelling and leads to degradation of the joint tissue. RA can cause permanent damage and deformities to joints, resulting in loss of function and ultimately leading to joint replacement surgery in some cases. In addition, some RA patients develop extra-articular manifestations such as rheumatoid nodules, interstitial lung disease and vasculitis.
According to the Arthritis Foundation, RA affects 2.1 million Americans and is about three times more common in women than men. Mortality rates for people with RA are double those of the general population. The cause of RA is not known, however, it is believed to be an autoimmune disease where the body's natural immune system attacks healthy joint tissue causing inflammation and subsequent joint damage.
About the Millennium/sanofi-aventis Collaboration
Millennium and sanofi-aventis have an alliance focused on developing and commercializing small molecule drugs for the treatment of inflammatory diseases such as rheumatoid arthritis and multiple sclerosis. MLN3897 (sanofi-aventis AVE9897) is one of several small molecules that are part of this collaboration, three of which are in the clinic.
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE® (bortezomib) for Injection, a novel cancer product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. The Company's website is http://www.millennium.com.
This press release contains "forward-looking statements," including statements about the Company's growth and development of products. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company's dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company's products; government and third- party reimbursement rates; the commercial success of VELCADE and INTEGRILIN® (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com.
Source: Millennium Pharmaceuticals
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