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Portola Pharmaceuticals Announces Positive Phase II Results for,PRT054021 for Prevention of Venous Thromboembolism Following Total,Knee Replacement Surgery

Data to be Presented at the XXI Congress of the International Society on Thrombosis and Haemostasis

SOUTH SAN FRANCISCO, Calif., April 04, 2007 /PRNewswire/ -- Portola Pharmaceuticals, Inc. today announced that it has received positive results from EXPERT, a Phase II study of its oral Factor Xa inhibitor, PRT054021, for the prevention of venous thromboembolism (VTE) following total knee replacement (TKR) surgery. Based on these results, Portola will advance PRT054021 into further clinical testing.

"Successful completion of EXPERT is a significant achievement and is the result of many years of work by the Portola team in the field of anticoagulants," said Charles Homcy, M.D., CEO of Portola. "We are pleased that the results of this study are consistent with our predicted therapeutic dose range for PRT054021."

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) enrolled over 200 patients at 20 medical centers in the United States and Canada in a randomized, active comparator, parallel-group trial. Patients were randomized to receive one of two oral doses of PRT054021, or Lovenox(R) (enoxaparin) given as a subcutaneous injection. The treatment period was for ten to fourteen days after surgery, at which time a venogram was obtained to determine the presence of VTE.

The EXPERT steering committee, which includes a group of leading physicians and orthopedic surgeons with significant experience in conducting clinical trials involving novel anticoagulants, determined that EXPERT met its objectives: PRT054021 appeared effective and safe at the two doses studied, and the results support advancing the compound into further clinical trials. Data from EXPERT will be presented at the XXI Congress of the International Society on Thrombosis and Haemostasis in Geneva, Swi
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