Nuvelo has announced that final results from a Phase IIa dose-escalating trial of rNAPc2 in patients with acute coronary syndromes (ACS) will be presented at the upcoming American Heart Association's Scientific Sessions 2005 in Dallas, Texas.
The multicenter, double-blind, placebo-controlled, ascending dose-escalation study was completed in May. The trial investigated the safety of rNAPc2 in combination with other antithrombotics in approximately 200 patients with ACS. The study consisted of a dose-ranging phase and a dose-confirmation phase. The primary focus of dose-ranging was to identify a well-tolerated dose in combination with other standard antithrombotic agents. In the dose-confirmation phase, 25 patients received 10 micrograms/kg, the highest dose evaluated, compared with placebo.
A novel anticoagulant, rNAPc2 is a naturally occurring protein that was originally isolated from the nematode. The anticoagulant effect of rNAPc2 results from its ability to block the factor VIIa/tissue factor protease complex, which is responsible for the initiation of the process leading to blood clot formation.