Nuvelo Initiates Clinical Trial Of Thrombin Inhibitor
Nuvelo has enrolled the first patient in a single-center, Phase 1 trial to determine the safety, tolerability and pharmacokinetics of escalating doses of NU172, a thrombin-inhibiting aptamer, in approximately 30 healthy male volunteers.
"This proof-of-concept trial will allow us to quickly determine NU172's potential to achieve rapid onset and offset of anticoagulation," said Michael Levy, executive vice president of research and development for Nuvelo. "We look forward to sharing top-line data from this trial in the first half of 2008."
NU172 is an aptamer designed to directly inhibit thrombin's ability to stimulate blood clot formation in the setting of medical procedures where human blood is exposed to foreign materials. Specifically, NU172 is being studied for use as a potential short-acting anticoagulant during procedures such as coronary artery bypass graft surgery and percutaneous interventions. Data from early animal models suggest that NU172 has the potential for predictable anticoagulant effects, rapid onset and offset of action, and avoidance of heparin-induced thrombocytopenia.
Aptamers are chemically synthesized single-stranded nucleic acids that form well-defined three-dimensional shapes, allowing them to bind target molecules in a manner that is conceptually similar to antibodies. Characteristics of aptamers include high specificity and affinity, and the ability to target protein-protein interactions.