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Nuvelo Announces Publication of Phase 2 rNAPc2 Study Results in,Journal of American College of Cardiology

a showed that rNAPc2 has an acceptable safety profile and was well tolerated in doses up to 10 mcg/kg in patients being treated for NSTE-ACS.

The heparin replacement stage was an open-label study evaluating the efficacy and safety of rNAPc2 in combination with half-dose or no unfractionated heparin in 52 patients. The goal of the study was to assess the potential of rNAPc2 by reducing the dose of, and ultimately replacing, unfractionated heparin in patients being treated for NSTE-ACS. Fifty-two patients were enrolled into two cohorts of 26 each. One cohort received 10 mcg/kg rNAPc2 and a half-dose regimen of heparin, and the second cohort received 10 mcg/kg rNAPc2 and no heparin.

Overall, the study enrolled 255 patients with NSTE-ACS and found that rNAPc2 did not statistically increase major plus minor bleeding despite prolonging the time to clot formation in a dose related fashion, as determined by the internationalized normalized ratio (INR). Hemorrhage rates were 2.5%, 2.9%, and 4.5% for placebo, low-dose (1.5-5 mcg/kg), and higher-dose (7.5 and10 mcg/kg) rNAPc2, respectively (overall p=0.77). Five cases of procedure- related thrombosis occurred among the no heparin treatment arm, and none occurred in the half-dose heparin arm. The data also demonstrate that at higher doses, rNAPc2 was associated with a greater than 50% reduction in the incidence and duration of ischemia as measured by continuous ECG monitoring. These same doses suppressed prothrombin fragment F1+2 levels compared to placebo (p<0.01).

About ACS

ACS accounts for more than one million hospitalizations annually in the United States. It occurs when an atherosclerotic plaque ruptures in a coronary artery, triggering the coagulation cascade, which results in the formation of a blood clot. The clot blocks the flow of blood to the heart muscle depriving it of oxygen (ischemia), which can result in unstable angina or heart attack.

About rNAPc2

A novel anticoagulan
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