CAMBRIDGE, Mass., May 31 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced positive top-line results from the Company’s randomized, double-blinded, placebo-controlled Phase II clinical trial of MLN1202, a novel humanized monoclonal antibody that specifically targets the CCR2 chemokine receptor, in patients at high risk for atherosclerotic cardiovascular disease. Preliminary analysis showed that MLN1202 was well tolerated and fully met its primary endpoint of a significant reduction in C-Reactive Protein (CRP) levels, an inflammatory biomarker associated with atherosclerosis, for months after a single dose of MLN1202. These results were statistically and clinically significant relative to the placebo control arm (p = 0.0275). No serious adverse events were observed in patients exposed to MLN1202. Trial results are expected to be submitted for presentation at a medical meeting.
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“The sustained activity of MLN1202 on CRP as seen in this trial of patients at high-risk for atherosclerosis offers potential for anti-inflammatory activity in the treatment of coronary artery disease,” said Eugene Braunwald, M.D., M.A.C.C., Chairman, TIMI Study Group, Brigham and Women’s Hospital. “Well-documented clinical studies suggest that successful prevention and treatment of coronary atherosclerosis supports monitoring of inflammation as well as cholesterol. These studies further suggest that statins alone may not be sufficient in the treatment of all patients. CRP is a well-established inflammatory prognostic indicator for cardiovascular events, and the effect that MLN1202 has on reducing CRP may be clinically meaningful.”
The Phase II clinical trial enrolled 108 patients who were at high risk for atherosclerosis and had documented elevations in CRP. Patients were randomized to receive a single dose of either MLN1202 or placebo and were then evaluated over a period of months for tolerability and CRP levels.
CRP is a critically important biomarker of cardiovascular risks. An increase in levels of this protein is a prognostic indicator for poor outcomes, including death, as documented in key medical literature over the past few years. Recent landmark clinical studies have shown that reduction in CRP levels are associated with reduced coronary atherosclerosis, as measured by imaging of plaque, and with a reduced risk of cardiovascular events. Using biomarkers, such as CRP, to better understand key pathways involved in certain diseases is a critical component of all Research and Development programs at Millennium.
“We are extremely encouraged by these data and believe they are the first public data on CCR2 antagonism to show significant and sustained clinical activity,” said Nancy Simonian, M.D., Senior Vice President, Clinical, Regulatory and Medical Affairs. “These data support our belief in the anti-inflammatory role of CCR2 and provide solid rationale for continued development of MLN1202 in atherosclerosis and other inflammatory diseases.”
Dr. Simonian will discuss these trial results during the Company’s presentation at the Bear Sterns Biotech Boston Confab at 2:30 P.M. ET today. The presentation will be webcast and accessible through the investor section of the Millennium website at http://www.millennium.com.
Millennium is also currently evaluating MLN1202 in a multicenter Phase II clinical trial involving approximately 40 patients with relapsing-remitting multiple sclerosis. Data from this trial are expected in the first half of 2007. Additional studies of MLN1202 in other indications are planned.
About MLN1202
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 a critical step in the development of atherosclerosis.
For more information about MLN1202 clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at (800) 589-9005.
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.
About Millennium
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. 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.
Editor’s Note: This release is available on the Media section of the Millennium website at http://www.millennium.com
This press release contains “forward-looking statements,” including statements about the Company’s discovery 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(R) (bortezomib) for Injection 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.
Contacts:
Theresa McNeely (media) Kyle Kuvalanka (investors) (617) 679-7405 (617) 761-4734
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CONTACT: Media: Theresa McNeely, +1-617-679-7405, or Investors: KyleKuvalanka, +1-617-761-4734, both of Millennium Pharmaceuticals
Web site: http://www.millennium.com//
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