|
Phase 2 trial expected to begin in late 2008 or early 2009
SAN CARLOS, CA, USA | June 4, 2008 | Nuvelo, Inc. (Nasdaq: NUVO) today announced that it has enrolled the first patient in a single-center, Phase 1b trial to determine the safety, tolerability and pharmacokinetics of bolus plus infusion dosing of NU172, a direct thrombin-inhibiting aptamer, in approximately 30 healthy male volunteers.
"We were very encouraged by the findings of the initial Phase 1 proof-of-concept trial showing NU172's potential to address the need for rapid onset and offset of anticoagulation in the setting of medical or surgical procedures such as coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "This Phase 1b trial will study bolus dosing followed by escalating infusion doses of NU172 for up to four hours, mimicking the drug's potential administration in CABG surgery. We will complete this trial in the third quarter of this year and anticipate moving forward with a Phase 2 study in the fourth quarter of 2008 or the first quarter of 2009."
Data from the single-center, Phase 1 trial showed that bolus doses of NU172 produced dose-dependent increases in anticoagulation, measured by activated clotting time (ACT). Upon discontinuation of NU172 the ACT showed a rapid return toward baseline with a plasma half-life of approximately 10 minutes. No serious adverse events occurred in the trial.
About Aptamers and NU172
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.
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 the Phase 1 trial and preclinical studies suggest that NU172 has the potential for predictable anticoagulant effects, rapid onset and offset of action, and avoidance of thrombocytopenia.
About Nuvelo and Archemix's Joint Collaborative Effort
In August 2006, Nuvelo expanded its collaboration with Archemix to develop and commercialize aptamers that have a short-acting anticoagulant effect. Under the agreement, Archemix is responsible for discovery of short-acting aptamers for use in medical procedures, and Nuvelo leads development and worldwide commercialization of these aptamers.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular disease, cancer and other debilitating medical conditions. Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor in Phase 1 development for use as a potential short-acting anticoagulant during medical or surgical procedures; and preclinical candidate NU206, a Wnt pathway modulator for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. In addition, Nuvelo is pursuing research programs in leukemia and lymphoma therapeutic antibodies and Wnt signaling pathway therapeutics to further expand its pipeline and create additional partnering and licensing opportunities.
SOURCE: Nuvelo, Inc. |
