ATLANTA -- TIMI 7 investigators said Monday that Hirulogreduced death and myocardial infarction in patientsparticipating in a pivotal trial. Results were presented at theAmerican College of Cardiology meeting here.
Biogen Inc. of Cambridge, Mass., is developing Hirulog as areplacement therapy for heparin. Hirulog is a 20-amino acidcompound based on hirudin, the natural anti-coagulatingenzyme secreted by leeches.
The trial was conducted by the Thrombolysis in MyocardialInfarction (TIMI) group at Brigham and Women's Hospital inBoston and was headed by Eugene Braunwald of HarvardMedical School.
The trial was a randomized, double-blind, dose-ranging studythat compared the activity of four doses of Hirulog and aspirinin 410 patients with unstable angina. Doses were .02 mg/kg/hr,.25 mg/kg/hr, .50 mg/kg/hr and 1 mg/kg/hr. Patients receiveda constant infusion of Hirulog for 72 hours.
Reduction of death and myocardial infarction in patientstreated with the three higher doses was seen both at the timeof discharge and at six weeks. Investigators also concluded thatHirulog was well-tolerated. Only one of the 410 patients had tohave the Hirulog discontinued due to major hemorrhage.
Hirulog will next be studied in a larger, international,randomized double-blind Phase III trial (called TIMI 8)comparing Hirulog with heparin in the management of unstableangina and non-Q wave myocardial infarction.
Hirulog is also in a Phase III angioplasty trial that is expectedto be completed later this year, and it is being tested in a PhaseII trial as an adjunct to thrombolytic therapy in treating heartattacks.
Biogen's stock (NASDAQ:BGEN) was down $1.25 a share onMonday, closing at $41.50.
-- Jim Shrine
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