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:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, ... less invasive and more durable cerebrospinal fluid treatments, ... funding.  The Series-A funding is led by Innova ... Fund, and other private investors.  Arkis, new financing ... instrumentation and the market release of its in-licensed ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):