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news.Millennium Pharmaceuticals has reported that MLN1202, a humanized monoclonal antibody, met its goal of reducing C-reactive protein levels in a placebo-controlled Phase II trial of patients at high-risk of atherosclerotic cardiovascular disease.
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C-reactive protein (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% of the overall patient population.
The Phase II 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. This study shows that MLN1202 was well-tolerated with no evidence of systemic immunosuppression. MLN1202 lowered CRP levels similarly in subjects on lipid-lowering agents, such as statins, compared to those not on these agents.
Nancy Simonian, chief medical officer at Millennium, said: “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. 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.”