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Portola Pharmaceuticals Announces Positive Data from a Phase II,Study of its Factor Xa Inhibitor at the XXI Congress of the,International Society on Thrombosis and Haemostasis

d A.G.G. Turpie, M.D., EXPERT's principal investigator and Professor of Medicine at McMaster University in Hamilton, Ontario. "We have long awaited a new generation of oral anticoagulants, and Portola has a promising compound with compelling drug characteristics resulting in consistent activity without the need for dose adjustment or monitoring. We will be closely following PRT054021 as it progresses into late-stage clinical trials."

Dr. Turpie discussed these data today in a poster session titled "Evaluation of the Factor Xa (fXA) Inhibitor, PRT054021 (PRT021), Against Enoxaparin in a Randomized Trial for the Prevention of Venous Thromboembolic Events after Total Knee Replacement (EXPERT)."

"We are very pleased by the EXPERT results, as PRT054021's clinical performance compared favorably to recent studies of enoxaparin for the prevention of VTE," said Dan Gretler, M.D., Portola's vice president of clinical and regulatory affairs. "We look forward to initiating our Phase III trials to further study our hypothesis that our oral, once-daily anticoagulant with superior pharmaceutical properties, including a relatively flat peak to trough concentration ratio, will lead to better outcomes for patients."

About EXPERT

EXPERT (Evaluation of the Factor Xa Inhibitor, PRT054021, against Enoxaparin in a Randomized Trial for the Prevention of Venous Thromboembolic Events after Unilateral Total Knee Replacement) randomized 215 U.S. and Canadian patients undergoing TKR surgery in a 2:2:1 ratio to receive 15 mg of PRT054021, 40 mg of PRT054021, or 30 mg of Lovenox(R) (enoxaparin) for 10-14 days. PRT054021 was given orally twice a day, and enoxaparin was given twice a day as a subcutaneous injection. The primary efficacy endpoint was the incidence of VTE through day 10-14 measured by venography. Safety endpoints included the incidence of major and clinically significant non-major bleeds through the day after venography. All efficacy and safety endpoints w
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