- Data confirm anti-inflammatory activity of novel CCR2 antagonist in
patients at high-risk for atherosclerosis -
CAMBRIDGE, Mass., Nov. 6 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that MLN1202, a novel, humanized monoclonal antibody met its primary endpoint of reducing C-reactive protein (CRP) levels in a placebo-controlled, Phase II trial of patients at high-risk for atherosclerotic cardiovascular disease. CRP level is an important, independent marker of cardiovascular morbidity and mortality. Additionally, the Company announced the identification of a genomic biomarker, which may be used for selecting patients most likely to respond to MLN1202. In this study, the genomic biomarker was identified in 53 percent of the overall patient population. These data were selected for oral presentation at the American Heart Association Scientific Session being held November 4-7, 2007 in Orlando, Florida.
"The anti-inflammatory effect of MLN1202 resulting in lower CRP, represents an exciting novel approach to reducing atherosclerosis by targeting inflammation," said Michael Davidson, M.D., Clinical Professor, Director of Preventive Cardiology, The University of Chicago Pritzker School of Medicine and Executive Medical Director, Radiant Research.
The Phase II clinical trial enrolled 108 patients at high-risk for atherosclerosis and with an elevated high-sensitivity CRP > 3.0 mg/dL. Patients were randomized to receive a single dose of either MLN1202 or placebo and were then followed for approximately 16 weeks.
Major findings of the trial include:
-- A single dose of MLN1202 led to a median reduction in CRP of 26.7%
relative to placebo on Day 57 after dosing (p = 0.0089), and was
significantly reduced up to Day 85 (19.1%; p = 0.0203).
-- 11.3% of MLN1202-treated patients experienced a reduction of CRP level
to less than or equal to 2 mg/L compared to 1.9% for placebo patients
at Day 57 (p = 0.0301).
-- CRP reductions were more likely in patients with a specified genomic
biomarker, a single nucleotide polymorphism (SNP) of a gene important
in inflammatory pathways. The SNP was identified in 53 percent of the
overall study population.
-- In SNP-positive patients, a single dose of MLN1202 led to a median
reduction in CRP of 35.3% relative to placebo at Day 57 (p =.0085).
-- Among the MLN1202-treated patients, 15.4% of SNP-positive patients
experienced a reduction of CRP level to less than or equal too
2 mg/L compared to 4.2% for SNP-negative patients at Day 57.
-- MLN1202 lowered CRP levels similarly in subjects on lipid-lowering
agents, such as statins, compared to those not on these agents.
-- MLN1202 was well-tolerated with no evidence of systemic
"These data support our belief in the anti-inflammatory role of a CCR2 antagonist and provide solid rationale for continued development of MLN1202 in atherosclerosis and other inflammatory diseases," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The association of a genomic biomarker with the biologic activity of the investigational drug validates our approach of using biomarkers to tailor drug treatments. We are actively seeking a partner to maximize the potential of MLN1202 in atherosclerosis and more broadly in other inflammatory diseases."
MLN1202, a novel humanized monoclonal antibody, specifically targets CCR2 chemokine receptors found on the surface of certain white blood cells, including macrophages and monocytes. Preclinical studies suggest that CCR2 plays an important role in the trafficking of monocytes and macrophages to sites of inflammation. The recruitment of macrophages to the arterial wall is believed to be an important step in the development of atherosclerosis and other inflammatory diseases.
MLN1202 also has been associated with reductions in gadolinium-enhancing lesions on magnetic resonance images of the brain in a separate multicenter Phase II clinical trial involving 50 patients with relapsing-remitting multiple sclerosis. Data from this trial were presented at the American Neurological Association meeting in October 2007.
About Atherosclerosis and Coronary Artery Disease
Coronary artery disease is the leading cause of death in the U.S. Approximately 12.5 million Americans have coronary artery disease and each year 1.5 million will experience acute myocardial infarction. Atherosclerosis, the leading cause of coronary artery disease, is the process whereby fatty substances, also known as plaques, build up on the inner lining of an artery. As the artery walls thicken, the blood flow through the vessels decreases. A blood clot may form, block the artery and stop the flow of blood. Research shows that inflammation plays an important role in the development of atherosclerosis. A growing body of evidence demonstrates that CRP levels in the blood correlate to the risk of developing atherosclerosis and coronary artery disease.
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium'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. Millennium'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(R) (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.
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (617) 761-4734
|SOURCE Millennium Pharmaceuticals, Inc.|
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