Nuvelo Announces Positive Proof-of-Concept Data With Anticogulant NU172
April 29 2008 - 8:30AM
PR Newswire (US)
- Subsequent Phase 1b study planned for mid 2008 with Phase 2
development to begin late in 2008 or in early 2009 - SAN CARLOS,
Calif., April 29 /PRNewswire-FirstCall/ -- Nuvelo, Inc.
(NASDAQ:NUVO) today 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. 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, 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. DATASOURCE: Nuvelo,
Inc. CONTACT: Lee Bendekgey, SVP, CFO and General Counsel of
Nuvelo, Inc., +1-650-517-8358, ; or Danielle Bertrand of WeissComm
Partners, +1-415-946-1056, , for Nuvelo, Inc. Web site:
http://www.nuvelo.com/
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