Phase II trial suggests that humanized monoclonal antibody can reduce C-reactive protein levels in patients at high risk for atherosclerotic cardiovascular disease
The novel, humanized monoclonal antibody MLN1202 can
reduce C-reactive protein levels in patients at high risk for atherosclerotic
cardiovascular disease, according to a presentation at the annual meeting of the
American Heart Association.
"The anti-inflammatory effect of MLN1202 resulting in lower CRP, represents
an exciting novel approach to reducing atherosclerosis by targeting inflammation,"
said Michael Davidson, MD, Clinical Professor, Director of Preventive Cardiology,
The University of Chicago Pritzker School of Medicine and Executive Medical Director,
Radiant Research.
The placebo-controlled, Phase II trial enrolled 108 patients at high risk
for atherosclerosis and with an elevated high-sensitivity C-reactive protein level
greater than 3.0 mg/dL. Patients were randomized to receive a single dose of MLN1202
or placebo and were then followed for approximately 16 weeks.
The single active dose resulted in a mean reduction in C-reactive protein
of 26.7 percent compared with placebo 57 days after dosing, a significant reduction
that was maintained up to day 85. Overall, 11.3 percent of actively treated patients
had protein level fall to 2 mg/dL or lower compared with 1.9 percent of placebo
patients.
Significant C-reactive protein reductions were more likely in patients with
a specified DNA marker, a single nucleotide polymorphism in a gene known to be
important in inflammatory pathways. The variant was found in 53 percent of the
study population as a whole.
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