Nuvelo, Inc. Initiates Phase 1 Clinical Trial of Thrombin Inhibitor, NU172
SAN CARLOS, Calif., Jan. 30 /PRNewswire-FirstCall/ -- Nuvelo, Inc. today announced that it 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.
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.
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 alfimeprase, a direct acting fibrinolytic in Phase 2 clinical development for the treatment of thrombotic-related disorders including acute ischemic stroke and catheter occlusion; 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 expects to continue its 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.
Information about Nuvelo is available at our website at http://www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which include statements regarding the timing and progress of Nuvelo's clinical stage and research programs, and the potential benefits that patients may experience from the use of our clinical stage compounds, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; stock market conditions; the impact of competitive products and technological changes; and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo's filings with the SEC, including without limitation Nuvelo's quarterly report on Form 10Q for the quarter ended September 30, 2007 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
CONTACT: Lee Bendekgey, SVP, CFO and General Counsel, of Nuvelo, Inc.,
+1-650-517-8358, firstname.lastname@example.org; or Nicole Foderaro of WeissComm
Partners, +1-415-946-1058, email@example.com, for Nuvelo, Inc.
Web site: http://www.nuvelo.com/