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Portola Pharmaceuticals Initiates Phase II Trial of Novel IV and Oral Anti-Platelet Drug in Non-Urgent Percutaneous Coronary Intervention
Date:12/9/2008

SOUTH SAN FRANCISCO, Calif., Dec. 9 /PRNewswire/ -- Portola Pharmaceuticals, a biopharmaceutical company developing innovative drugs that provide significant advances in cardiovascular disease, inflammatory disease and cancer, today announced that it 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 (PCI).

"With the initiation of our second Phase II trial within a month, we are on track to successfully achieve our company milestones for 2008," said Charles Homcy, M.D., president and chief executive officer of Portola. "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."

The Phase II randomized, double-blind, multi-center trial will evaluate the safety, tolerability and efficacy of an intravenous (IV) bolus of PRT060128 followed by one of three doses (50mg, 100mg, 150mg) of the oral formulation of PRT060128 compared to clopidogrel (Plavix(R)) in approximately 800 patients undergoing non-urgent PCI. 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.

"Despite the prevalence of anti-platelet therapies available today, major adverse cardiac events continue to occur among patients undergoing PCI," said Robert A. Harrington, M.D., study chair and director of the Duke Clinical Research Institute at Duke University Medical Center in Durham, NC. "PRT060128 appears to be a novel, direct acting, reversible anti-platelet agent and we are very interested to see if these p
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