Healthcare Industry News: Venous Thromboembolism
News Release - April 4, 2007
Portola Pharmaceuticals Announces Positive Phase II Results for PRT054021 for Prevention of Venous Thromboembolism Following Total Knee Replacement SurgeryData to be Presented at the XXI Congress of the International Society on Thrombosis and Haemostasis
SOUTH SAN FRANCISCO, Calif., April 4 (HSMN NewsFeed) -- 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® (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, Switzerland (July 6-12, 2007).
"There is a tremendous need for a once a day, oral anticoagulant to replace and improve upon current therapies," said A.G.G. Turpie, M.D., EXPERT's principal investigator and Professor of Medicine at McMaster University in Hamilton, Ontario. "We are encouraged by the EXPERT results and we look forward to studying the unique properties of PRT054021 in additional clinical trials."
About PRT054021 - Portola's Factor Xa Inhibitor
PRT054021 is an oral Factor Xa inhibitor, an anticoagulant initially being studied for the prevention of Venous Thromboembolism in patients who have undergone orthopedic surgery. Portola expects to develop PRT054021 for additional indications including stroke prevention in patients with atrial fibrillation and secondary prevention of myocardial infarction and stroke. Factor Xa is a validated target (one for which there are approved drugs on the market), and inhibiting its activity is believed to have superior anticoagulant properties compared to other targets such as thrombin. Portola believes its oral Factor Xa inhibitor will offer several advantages, including a long half-life to support once daily dosing and a low peak-to-trough concentration ratio, resulting in consistent activity that does not require monitoring or dose adjustment. In addition, PRT054021 is not excreted in the kidneys and therefore will not require dose adjustment in patients with impaired renal function.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals, Inc. is a privately-held biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapeutics for acute and chronic cardiovascular and vascular disease. Portola is currently developing two clinical stage antithrombotics. Portola's lead compound, PRT054021, is an oral Factor Xa inhibitor for the prevention of Venous Thromboembolism after orthopedic surgery, for stroke prevention in patients with atrial fibrillation and for secondary prevention of myocardial infarction (MI) and stroke. Portola's second compound, PRT060128, is an oral and intravenous ADP receptor antagonist for patients with acute coronary syndrome, for the prevention of cardiovascular events in patients undergoing percutaneous coronary intervention and for secondary prevention of MI and stroke. PRT060128 is currently in Phase I clinical trials.
Source: Portola Pharmaceuticals
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