Nuvelo, Inc.
(Nasdaq: NUVO) announced positive results from the Phase 1
proof-of-concept trial (n=30) of NU172, demonstrating that the
thrombin-inhibitor achieved rapid onset and offset of anticoagulation after
a single bolus dose with a favorable safety profile.
"There is a significant need for anticoagulants with fewer side effects
and more predictable dosing than treatments currently available today,"
said David J. Schneider, M.D., professor of medicine and director of
cardiology and vascular biology at the University of Vermont. "NU172
represents a new approach to anticoagulation for medical and surgical
procedures through its potential to produce rapid and predictable onset of
anticoagulation followed by rapid reversal once the infusion is
discontinued."
The single-center, Phase 1 trial examined the safety, tolerability and
pharmacokinetics of escalating bolus doses of NU172 in normal, healthy
volunteers. In the trial, NU172 produced dose-dependent increases in
anticoagulation, measured by activated clotting time (ACT). The 2.00 mg/kg
bolus dose of NU172 achieved target ACTs of approximately 400 seconds. Upon
withdrawal of NU172 the ACT showed a rapid return toward baseline with a
plasma half-life of NU172 of approximately 10 minutes. No serious adverse
events occurred in the trial.
"We are very encouraged by these findings and NU172's potential to
address the need for rapid onset and offset of anticoagulation in medical
procedures such as coronary artery bypass graft surgery and percutaneous
coronary intervention," said Dr. Ted W. Love, chairman and chief executive
officer of Nuvelo. "We plan to launch a Phase 1b trial of bolus dosing
followed by escalating infusion doses of NU172 later this quarter, which
should enable us to quickly begin a Phase 2 study evaluating NU172 in
medical or surgical procedures in the fourth quarter of 2008 or the first
quarter of 2009."
According to the American Heart Association, more than 450,000 coronary
artery bypass graft (CABG) procedures and more than 1.2 million
percutaneous coronary interventions (PCIs) are performed annually in the
United States. Heparin, which must be paired with its antitode protamine
for reversal, is the current standard of care for anticoagulation in CABG
surgeries and PCI.
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.
This press release contains "forward-looking statements," which include
statements regarding the timing, progress and anticipated completion of
Nuvelo's clinical stage and research programs, the anticipated availability
of top-line data, projected operating expenses and cash usage 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 and the regulatory approval process; 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; and the impact of competitive products and technological
changes. These and other factors are identified and described in more
detail in Nuvelo's filings with the SEC, including without limitation
Nuvelo's annual report on Form 10-K for the year ended December 31, 2007
and subsequent filings. We disclaim any intent or obligation to update
these forward-looking statements.
Nuvelo, Inc.
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