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news.NicOx SA has received positive results from a phase IIa study showing that NCX 4016 is significantly more effective than aspirin and placebo at preventing platelet activation in diabetes.
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Increased platelet activation is a feature of diabetes that contributes to the high incidence of cardiovascular events in diabetic patients. NCX 4016 is a novel antithrombotic and vascular anti-inflammatory agent, which is being developed by NicOx for the treatment of peripheral arterial obstructive disease (PAOD) and other cardiovascular-related disorders.
The prospective, double-blind, randomized trial showed that NCX 4016 was statistically significantly better than aspirin and placebo on the primary endpoint of O’Brien platelet filtration test closure time, a procedure used to measure the activation of platelets under conditions of high-shear flow. Aspirin was not different from placebo.
These data suggest NCX 4016 may be more effective than aspirin at inhibiting platelet activation in diabetic patients and may have relevance for the prevention of cardiovascular complications in diabetes.
NicOx also recently announced the completed enrollment of 450 patients in a multi-center, phase II trial of NCX 4016 in PAOD. The results of this trial are expected to be available at the end of 2005.