Millennium's MLN1202 meets primary endpoint in atherosclerosis study

By Elaine Rigoli

Tampa, Fla., May 31 - Millennium Pharmaceuticals, Inc. announced positive top-line results from the company's randomized, double-blinded, placebo-controlled phase 2 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.

Millennium said 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, the company said in a news release.

"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," said Eugene Braunwald, chairman of the TIMI Study Group at Brigham and Women's Hospital in Boston, in a news release.

The phase 2 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 a placebo and were then evaluated over a period of months for tolerability and CRP levels.

Millennium Pharmaceuticals is a biopharmaceutical company based in Cambridge, Mass.

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