Navigation Links
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 tzerland (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 fibrilla tion 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.

CONTACT: Ember Garrett of PN Life Sciences, +1-619-849-5383,, for Portola Pharmaceuticals, Inc. egarrett@pnlifesciences.com

Web site: http://www.portola.com/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. 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
2. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
3. Portola Pharmaceuticals Presents Positive Phase I Data of Its ADP Receptor Antagonist at the American College of Cardiology
4. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
10. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
11. Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib Combination Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... the largest share of the market in 2016 and ... dominance can be attributed to a large number of ... (US hold the largest share in the patient temperature ... benefits such as reducing loss of blood during surgeries, ...
(Date:12/8/2016)... 8, 2016 Research and Markets has announced ... Trends - Adhesion Type, Application, Usability - Forecast to 2025" ... , ... Market is poised to grow at a CAGR of around 3.2% ... market is witnessing include advancements in extracellular microelectrode arrays and intracellular ...
(Date:12/8/2016)... Quebec , Dec. 8, 2016  Valeant ... and TSX: VRX) ("Valeant") today announced positive results ... clinical study to assess the safety and efficacy ... the treatment of plaque psoriasis. ... subjects with moderate to severe psoriasis, IDP-118 showed ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... December 09, 2016 , ... MEDI+SIGN®, a provider ... that a new solution for Emergency Departments (ED) has been added to their ... Emergency Department examination rooms, and with a simplified pallet of information available to ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... with distinction by the Undersea and Hyperbaric Medical Society (UHMS), the leading authority ... care and patient safety. Only a few hospitals and facilities have earned this ...
(Date:12/8/2016)... ... December 08, 2016 , ... Seavest ... Property owned by an affiliate of Seavest, has won a prestigious national healthcare ... Chester County ambulatory care center (ACC) was named “Best New Development, MOBs and ...
(Date:12/8/2016)... ... December 08, 2016 , ... David J. Dykeman , ... Greenberg Traurig, LLP, will speak at DeviceTalks West, Dec. 12, 2016, at the Fairmont ... and attorneys from the firm’s global Life Sciences & Medical Technology Group have been ...
(Date:12/8/2016)... ... 2016 , ... Catalent Pharma Solutions, the leading global provider ... products, today announced that it had joined the Pharmaceutical Supply Chain Initiative (PSCI). ... unite pharmaceutical and healthcare companies that share a vision of better, social, environmental ...
Breaking Medicine News(10 mins):