NUVELO BEGINS PHASE II ACS TRIAL

Nuvelo announced enrollment of the first patient in a Phase II clinical trial evaluating rNAPc2 (recombinant nematode anticoagulant protein c2) as a potential replacement for heparin in patients being treated for acute coronary syndromes (ACS). ACS occurs when atherosclerotic plaque ruptures in a coronary artery, which triggers the coagulation cascade resulting in the formation of a blood clot. The clot blocks the flow of blood to the heart muscle, depriving it of oxygen and resulting in unstable angina or heart attack.

This Phase II trial is a single-arm, open-label study that is evaluating the efficacy and safety of rNAPc2 by reducing the dose of, and ultimately replacing, unfractionated heparin in patients being treated for ACS. The study will enroll 50 to 100 patients and is being conducted in approximately 25 centers across the U.S. and Canada with the TIMI Study Group. Patients who can be randomized within 48 hours of symptoms will be enrolled in cohorts of 25 patients each. The initial group of patients will receive a half-dose regimen of unfractionated heparin, and 10 micrograms/kg of rNAPc2. The next group will receive no heparin and the same dose of rNAPc2.