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Portola Pharma begins Phase II trial of cardiac drug

Portola Pharmaceuticals has initiated a Phase II clinical trial of the intravenous formulation of PRT060128 in patients experiencing an ST-segment elevation myocardial infarction, a type of heart attack.

Erase-MI is a randomized, double-blind, placebo-controlled study assessing the use of PRT060128 upon diagnosis of STEMI, which is a type of heart attack that occurs when a coronary artery becomes completely blocked.

Prior to percutaneous coronary intervention (PCI), patients will be dosed with IV PRT060128 or placebo, in addition to standard treatment, in an effort to accelerate the opening of the blocked artery and restore blood flow to the heart. The effect of PRT060128 will be assessed through a measurement of coronary blood flow immediately prior to PCI.

Erase-MI will enroll approximately 200 patients across North America and Europe. PRT060128 is an antiplatelet compound that is said to be the only reversible IV and oral ADP receptor antagonist in clinical development.

Dan Gretler, vice president, clinical development at Portola, said: “We plan to initiate a larger Phase II trial in 2008 which will study both formulations of PRT060128 starting with the IV formulation in the hospital and transitioning to chronic oral administration.”