�Nuvelo, Inc.
(Nasdaq: NUVO) announced plus results from the Phase 1b
proof-of-concept trial of NU172, demonstrating that the direct thrombin
inhibitor chop-chop produced and maintained anticoagulation with a rapid
retort toward baseline after the infusion terminated with a favorable base hit
profile.
"NU172 has the potential to address many of the limitations of
currently available anticoagulants apt the profile we have seen to date
in preclinical and Phase 1 testing, including its power to produce rapid
and predictable oncoming and offset of anticoagulation without the need for an
antidote, its potentiality ability to work in stagnant rake, its
predominately non-renal headroom, and the option to stop and restart
anticoagulation as requisite 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 overture
to anticoagulation for procedures such as coronary artery bypass graft
(CABG) surgical operation, kidney dialysis, and transcutaneous coronary intervention
(PCI)."
The single-center, Phase 1b test examined the safety, tolerability and
pharmacokinetics of intravenous bolus asset infusion dosing of NU172, in 24
healthy male volunteers. Volunteers were disposed a 2 mg/kg bolus dose
followed by escalating infusion doses of NU172 for four hours. In all quadruplet
cohorts, NU172 produced dose-dependent increases in anticoagulation,
metrical by activated clotting clip (ACT), factor II time (PT) and
activated partial thromboplastin time (aPTT). The highest infusion dosage
rate tested, 6.0 mg/kg/hr, resulted in an average ACT per national ranging
from 373 to 414 seconds and an increase of approximately iII times
baseline. Average PT values per subject ranged from 56 to 92 seconds and
had an increase of approximately pentad times baseline. Average aPTT values
per subject ranged from one hundred thirty to 178 seconds and had an increase of
approximately five times baseline. All measurements were retained stably
end-to-end the four-hour infusion. Once the infusion ended, the ACT and
other curdling parameters showed a rapid return toward baseline,
logical with the short plasma half-life of NU172 ascertained in the Phase
1a trial. In addition, NU172 was well-tolerated with no serious adverse
events.
"In this written report, we were able to identify a dose that meets or exceeds
the level of anticoagulation requisite for the indications we plan to
evaluate, including CABG surgery," said Dr. Ted W. Love, president and headman
executive officeholder of Nuvelo. "In summation to encouraging our previous
proof-of-concept information, the Phase 1b discipline shows that anticoagulation with
NU172 lav be retained for foursome hours, which is yearner 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 one thousand thousand dialysis procedures,
and 1.2 billion PCIs are performed each year in the U.S. During these
procedures, anticoagulants ar given to prevent blood clotting. In CABG
procedures and often in dialysis, the anticoagulation effect of heparin
must be transposed 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 area
molecules in a manner that is conceptually alike to antibodies.
Characteristics of aptamers include high specificity and affinity, and the
ability to target protein-protein interactions.
NU172 is an aptamer intentional to straight 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 potency short-acting anticoagulant medication during procedures
such as coronary artery bypass transplant surgery, kidney dialysis and
percutaneous coronary interventions. Data from the Phase 1 trial and
preclinical studies suggest that NU172 has the voltage to get rapid
and predictable onset and offset of anticoagulation, work in stagnant
blood, avoid thrombopenia, and has the potency for non-renal
clearance.
About Nuvelo and Archemix's Joint Collaborative Effort In August 2006, Nuvelo expanded its collaborationism with Archemix to
acquire and market aptamers that have a short-acting anticoagulant
effect. Under the understanding, Archemix is responsible for discovery of
short-acting aptamers for use in medical procedures, and Nuvelo leads
development and worldwide commercialisation of these aptamers.
About Nuvelo Nuvelo, Inc. is dedicated to improving the lives of patients through
the discovery, developing and commercialization of novel drugs for acute
cardiovascular disease, malignant neoplastic disease and other debilitating medical conditions.
Nuvelo's development line 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 exploitation for the potential discussion of
chemotherapy/radiation therapy-induced mucositis and incitive bowel
disease. In addition, Nuvelo is pursuing enquiry programs in leukemia and
lymphoma therapeutic antibodies and Wnt signal 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, and the potential benefits
that patients crataegus oxycantha experience from the use of our clinical stage compounds,
which statements ar hereby identified as "advanced statements" for
purposes of the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. Such statements ar based on our management's current
expectations and involve risks and uncertainties. Actual results and
performance could differ materially from those projected in the
modern statements as a result of many factors, including, without
restriction, uncertainties relating to drug discovery and the regulatory
approval treat; 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 shock of
competitory products and technological changes. These and other factors are
identified and described in more detail in Nuvelo's filings with the SEC,
including without restriction Nuvelo's quarterly report on Form 10-Q for the
quarter all over June 30, 2008 and subsequent filings. We disclaim any spirit
or certificate of indebtedness to update these advanced statements.
Nuvelo, Inc.
http://www.nuvelo.com
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