SAN CARLOS, Calif., April 29 Nuvelo, Inc.(Nasdaq: NUVO) today announced positive results from the Phase 1proof-of-concept trial (n=30) of NU172, demonstrating that thethrombin-inhibitor achieved rapid onset and offset of anticoagulation after asingle bolus dose with a favorable safety profile.
"There is a significant need for anticoagulants with fewer side effectsand more predictable dosing than treatments currently available today," saidDavid J. Schneider, M.D., professor of medicine and director of cardiology andvascular biology at the University of Vermont. "NU172 represents a newapproach to anticoagulation for medical and surgical procedures through itspotential to produce rapid and predictable onset of anticoagulation followedby rapid reversal once the infusion is discontinued."
The single-center, Phase 1 trial examined the safety, tolerability andpharmacokinetics of escalating bolus doses of NU172 in normal, healthyvolunteers. In the trial, NU172 produced dose-dependent increases inanticoagulation, measured by activated clotting time (ACT). The 2.00 mg/kgbolus dose of NU172 achieved target ACTs of approximately 400 seconds. Uponwithdrawal of NU172 the ACT showed a rapid return toward baseline with aplasma half-life of NU172 of approximately 10 minutes. No serious adverseevents occurred in the trial.
"We are very encouraged by these findings and NU172's potential to addressthe need for rapid onset and offset of anticoagulation in medical proceduressuch as coronary artery bypass graft surgery and percutaneous coronaryintervention," said Dr. Ted W. Love, chairman and chief executive officer ofNuvelo. "We plan to launch a Phase 1b trial of bolus dosing followed byescalating infusion doses of NU172 later this quarter, which should enable usto quickly begin a Phase 2 study evaluating NU172 in medical or surgicalprocedures in the fourth quarter of 2008 or the first quarter of 2009."
According to the American Heart Association, more than 450,000 coronaryartery bypass graft (CABG) procedures and more than 1.2 million percutaneouscoronary interventions (PCIs) are performed annually in the United States.Heparin, which must be paired with its antitode protamine for reversal, is thecurrent standard of care for anticoagulation in CABG surgeries and PCI.
About Aptamers and NU172
Aptamers are chemically synthesized single-stranded nucleic acids thatform well-defined three-dimensional shapes, allowing them to bind targetmolecules in a manner that is conceptually similar to antibodies.Characteristics of aptamers include high specificity and affinity, and theability to target protein-protein interactions.
NU172 is an aptamer designed to directly inhibit thrombin's ability tostimulate blood clot formation in the setting of medical procedures wherehuman blood is exposed to foreign materials. Specifically, NU172 is beingstudied for use as a potential short-acting anticoagulant during proceduressuch as coronary artery bypass graft surgery and percutaneous interventions.Data from the Phase 1 trial and preclinical studies suggest that NU172 has thepotential for predictable anticoagulant effects, rapid onset and offset ofaction, and avoidance of thrombocytopenia.
About Nuvelo and Archemix's Joint Collaborative Effort
In August 2006, Nuvelo expanded its collaboration with Archemix to developand commercialize aptamers that have a short-acting anticoagulant effect.Under the agreement, Archemix is responsible for discovery of short-actingaptamers for use in medical procedures, and Nuvelo leads development andworldwide commercialization of these aptamers.
Nuvelo, Inc. is dedicated to improving the lives of patients through thediscovery, development and commercialization of novel drugs for acutecardiovascular disease, cancer and other debilitating medical conditions.Nuvelo's developmen