SAN CARLOS, Calif., Jan. 30 Nuvelo, Inc.(Nasdaq: NUVO) today announced that it has enrolled the first patient in asingle-center, Phase 1 trial to determine the safety, tolerability andpharmacokinetics 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'spotential to achieve rapid onset and offset of anticoagulation," said MichaelLevy, executive vice president of research and development for Nuvelo. "Welook forward to sharing top-line data from this trial in the first half of2008."
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 early animal models suggest that NU172 has the potential forpredictable anticoagulant effects, rapid onset and offset of action, andavoidance of heparin-induced thrombocytopenia.
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.
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 development pipeline includes alfimeprase, a direct actingfibrinolytic in Phase 2 clinical development for the treatment ofthrombotic-related disorders including acute ischemic stroke and catheterocclusion; NU172, a direct thrombin inhibitor in Phase 1 development for useas a potential short-acting anticoagulant during medical or surgicalprocedures; and preclinical candidate NU206, a Wnt pathway modulator for thepotential treatment of chemotherapy/radiation therapy-induced mucositis andinflammatory bowel disease . In addition, Nuvelo expects to continue itsresearch programs in leukemia and lymphoma therapeutic antibodies and Wntsignaling pathway therapeutics to further expand its pipeline and createadditional partnering and licensing opportunities.
Information about Nuvelo is available at our website athttp://www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which includestatements regarding the timing and progress of Nuvelo's clinical stage andresearch programs, and the potential benefits that patients may experiencefrom the use of our clinical stage compounds, which statements are herebyidentified as "forward-looking statements" for purposes of the safe harborprovided by the Private Securities Litigation Reform Act of 1995. Suchstatements are based on our management's current expectations and involverisks and uncertainties. Actual results and performance could differmaterially from those projected in the forward-looking statements as a resultof many factors, including, without limitation, uncertainties relating to drugdiscovery; clinical development processes; enrollment rates for patients inour clinical trials; changes in relatio