Nuvelo Initiates Phase 1B Clinical Trial of Anticoagulant NU172
June 04 2008 - 7:30AM
PR Newswire (US)
- Phase 2 trial expected to begin in late 2008 or early 2009 - SAN
CARLOS, Calif., June 4 /PRNewswire-FirstCall/ -- 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. 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 quarterly report on Form 10-Q for the quarter ended March
31, 2008 and subsequent filings. We disclaim any intent or
obligation to update these forward-looking statements. DATASOURCE:
Nuvelo, Inc. CONTACT: Lee Bendekgey, SVP and Chief Financial
Officer of Nuvelo, +1-650-517-8358, ; or Nicole Foderaro of
WeissComm Partners, +1-415-946-1058, , for Nuvelo, Inc. Web site:
http://www.nuvelo.com/
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