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news.Portola Pharmaceuticals, a biopharmaceutical company, has initiated patient enrollment in Innovate-PCI, a large Phase II clinical trial of PRT060128, the company's novel P2Y12 ADP receptor antagonist, in patients undergoing non-urgent percutaneous coronary intervention.
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The Phase II randomized, double-blind, multi-center trial will evaluate the safety, tolerability and efficacy of an intravenous bolus of PRT060128 followed by one of three doses (50mg, 100mg, 150mg) of the oral formulation of PRT060128 compared to clopidogrel (Plavix) in approximately 800 patients undergoing non-urgent percutaneous coronary intervention.
The study is designed to evaluate multiple endpoints in order to assess dose in relation to clinical efficacy, biological activity, tolerability and safety of PRT060128 during a minimum 60-day treatment phase.
Charles Homcy, president and CEO of Portola, said: “With the initiation of our second Phase II trial within a month, we are on track to successfully achieve our company milestones for 2008.
“With its reversible and competitive properties and intravenous and oral delivery, PRT060128 has the potential for a broader therapeutic window and to become an important anti-platelet therapy in treating thrombosis patients in both the acute and chronic settings.”