- 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 t
|SOURCE Nuvelo, Inc.|
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