MEDICINES COMPANY REPORTS POSITIVE DATA ON CCB

The Medicines Company announced that its three Phase III safety trials of Cleviprex (clevidipine) have met their prespecified endpoints. Cleviprex is an intravenous, ultrashort-acting calcium-channel blocker (CCB) under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.

The safety trials, called ECLIPSE, are a series of evaluations enrolling 1,500 patients in the perioperative treatment of hypertension. The three ECLIPSE studies compared Cleviprex with active comparators: nitroglycerin, sodium nitroprusside and nicardipine.

For the primary safety objectives, investigators measured the incidences of death, stroke, myocardial infarction and renal dysfunction. The secondary objectives were to evaluate the adverse experiences with Cleviprex and its blood pressure lowering effect. Health economics parameters will also be assessed. The primary data have been reviewed with investigators, and a full presentation of the trials is expected to occur at a medical meeting in the first quarter of 2007.

If approved, Cleviprex would be the first of a third generation of intravenous dihydropyridine CCBs. It acts by selectively relaxing the smooth muscle cells that line small arteries, resulting in widening of the artery and reduction of blood pressure with a minimal effect on the heart rate.