The data suggests recombinant nematode anticoagulant protein c2 or rNAPc2, has an acceptable safety profile and is well tolerated in doses up to 10 microgram/kg, in patients with non-ST-elevation acute coronary syndromes (ACS).
This multi-center, double-blind trial investigated the safety of rNAPc2 in combination with other anticoagulants in 200 patients with ACS. The investigators observed the effects of an escalating dose range in order to identify a safe and active dose.
Based on the encouraging safety results from this trial, Nuvelo plans to initiate a further study in the second half of 2005 to assess the potential of rNAPc2 to replace heparin as a first-line therapy in ACS. This second phase II trial will include up to 100 patients and will provide supplementary efficacy data.
“Given the additional data that we anticipate from our upcoming heparin replacement study, we will have data in approximately 800 subjects from various phase I and 2 trials with rNAPc2,” said Ted Love, president and CEO of Nuvelo. “We believe that we have identified a cost-effective strategy to generate safety and efficacy data that will facilitate our objective to secure a strategic partner to further support development and commercialization of rNAPc2 for ACS.”
Acute coronary syndrome is a potentially life-threatening heart condition that accounts for over one million hospitalizations annually in the US. It occurs when an 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 results in either acute myocardial infarction or unstable angina.