Nuvelo Announces Positive Phase 1b Proof-of-Concept Data With Anticoagulant NU172
August 14 2008 - 7:30AM
PR Newswire (US)
- Phase 2 development to begin in late 2008 or in early 2009 - SAN
CARLOS, Calif., Aug. 14 /PRNewswire-FirstCall/ -- Nuvelo, Inc.
(NASDAQ:NUVO) today announced positive results from the Phase 1b
proof-of-concept trial of NU172, demonstrating that the direct
thrombin inhibitor rapidly produced and maintained anticoagulation
with a rapid return toward baseline after the infusion ended with a
favorable safety profile. "NU172 has the potential to address many
of the limitations of currently available anticoagulants given the
profile we have seen to date in preclinical and Phase 1 testing,
including its ability to produce rapid and predictable onset and
offset of anticoagulation without the need for an antidote, its
potential ability to work in stagnant blood, its predominately
non-renal clearance, and the option to stop and restart
anticoagulation as needed during or after surgery," said A. Michael
Lincoff, M.D., vice chairman of the department of cardiovascular
medicine and an interventional cardiologist at the Cleveland
Clinic. "Because of these characteristics, NU172 could potentially
offer an improved approach to anticoagulation for procedures such
as coronary artery bypass graft (CABG) surgery, kidney dialysis,
and percutaneous coronary intervention (PCI)." The single-center,
Phase 1b trial examined the safety, tolerability and
pharmacokinetics of intravenous bolus plus infusion dosing of
NU172, in 24 healthy male volunteers. Volunteers were given a 2
mg/kg bolus dose followed by escalating infusion doses of NU172 for
four hours. In all four cohorts, NU172 produced dose-dependent
increases in anticoagulation, measured by activated clotting time
(ACT), prothrombin time (PT) and activated partial thromboplastin
time (aPTT). The highest infusion dose rate tested, 6.0 mg/kg/hr,
resulted in an average ACT per subject ranging from 373 to 414
seconds and an increase of approximately three times baseline.
Average PT values per subject ranged from 56 to 92 seconds and had
an increase of approximately five times baseline. Average aPTT
values per subject ranged from 130 to 178 seconds and had an
increase of approximately five times baseline. All measurements
were maintained stably throughout the four-hour infusion. Once the
infusion ended, the ACT and other coagulation parameters showed a
rapid return toward baseline, consistent with the short plasma
half-life of NU172 observed in the Phase 1a trial. In addition,
NU172 was well-tolerated with no serious adverse events. "In this
study, we were able to identify a dose that meets or exceeds the
level of anticoagulation needed for the indications we plan to
evaluate, including CABG surgery," said Dr. Ted W. Love, chairman
and chief executive officer of Nuvelo. "In addition to supporting
our previous proof-of-concept data, the Phase 1b study shows that
anticoagulation with NU172 can be maintained for four hours, which
is longer than a typical CABG procedure. We are on track to launch
a Phase 2 study evaluating NU172 in the fourth quarter of 2008 or
the first quarter of 2009." Approximately 450,000 CABG procedures,
50 million dialysis procedures, and 1.2 million PCIs are performed
annually in the U.S. During these procedures, anticoagulants are
given to prevent blood clotting. In CABG procedures and often in
dialysis, the anticoagulation effect of heparin must be reversed
with protamine once the procedure has been completed. 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, kidney dialysis and percutaneous coronary
interventions. Data from the Phase 1 trial and preclinical studies
suggest that NU172 has the potential to produce rapid and
predictable onset and offset of anticoagulation, work in stagnant
blood, avoid thrombocytopenia, and has the potential for non-renal
clearance. 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 which has completed Phase 1 development for use
as a potential short-acting anticoagulant during medical or
surgical procedures; and NU206, a Wnt pathway modulator in Phase 1
development 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, 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 June
30, 2008 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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