Navigation Links
Portola Announces Data Showing Its Anti-Platelet Drug Inhibits Platelets in Clopidogrel (Plavix(R)) Non-Responders
Date:11/12/2008

- Direct-Acting PRT060128 Provides Reversible, High-level Platelet

Inhibition with Immediate Onset of Action -

NEW ORLEANS and SOUTH SAN FRANCISCO, Calif., Nov. 12 /PRNewswire/ -- Portola Pharmaceuticals, a biopharmaceutical company developing innovative drugs that provide significant advances in cardiovascular and inflammatory diseases, and cancer, today announced new clinical data that demonstrate PRT060128, the Company's novel anti-platelet drug that directly and reversibly inhibits the P2Y12 ADP receptor, overcomes high platelet reactivity (HPR) in patients who do not respond to clopidogrel (Plavix(R)). The results [Abstract #5603] were presented at the American Heart Association (AHA) Scientific Sessions 2008 in New Orleans, LA.

Studies show there is substantial variability in patient response to clopidogrel therapy with up to 30% of patients not responding to treatment. Numerous studies link this suboptimal treatment response to poor clinical outcomes.

PRT060128 is the only reversible, direct acting, intravenous (IV) and oral ADP receptor antagonist in clinical development. Inhibiting the P2Y12 ADP receptor on platelets has been proven to prevent thrombosis and subsequent heart attacks. Portola believes that PRT060128 may provide significant clinical benefit through immediate, high-level platelet inhibition in the acute setting and a seamless transition to predictable, reversible platelet inhibition in the chronic setting.

"Of the millions of cardiac patients treated with clopidogrel anti- platelet therapy every year, a significant portion do not respond, and remain at high risk for major adverse cardiac events," said Paul A. Gurbel, M.D., principal investigator and Director of Cardiovascular Research at the Center for Thrombosis Research at Sinai Hospital, Baltimore, MD. "These results show that this direct-acting anti-platelet agent with a novel mechanism of action may have the potential to fill this significant treatment gap and meet a major unmet need."

Clinical Study Details and Results

In this study, 20 patients were identified with stable coronary artery disease that were treated with chronic clopidogrel (75mg) and aspirin therapy and have HPR. These clopidogrel non-responders were treated with one oral dose of PRT060128 (60mg) at 12 to 16 hours after the previous day's dose of clopidogrel. Platelet aggregation was determined by ADP and collagen-induced aggregation and pharmacodynamic assays. The mean platelet reactivity was reduced from the highest (non-responder) to lowest (normal responder) tertile, following dosing with PRT060128, and achieved the predefined endpoint. Inhibition of thrombosis was highly significant in these non-responder patients. The oral dose of PRT060128 chosen for this study is at the low end of the dosing range that will be evaluated in the Portola's upcoming Phase II study.

"We are encouraged by these clinical results suggesting PRT060128 may be effective and well tolerated in clopidogrel non-responders," said Charles Homcy, M.D., president and chief executive officer of Portola. "This novel agent has immediate, predictable and reversible platelet inhibition that appears to overcome HPR in non-responders and other major limitations of clopidogrel."

Previously conducted clinical trials showed that PRT060128 was well- tolerated without serious adverse events. In addition, PRT060128 showed predictable, dose-dependent platelet inhibition. Portola expects to begin patient enrollment in an 800 patient Phase II study with the IV and oral forms of PRT060128 for prevention of thrombotic events in patients undergoing non- urgent percutaneous coronary interventions (PCI) before the end of this year.

About Portola Pharmaceuticals, Inc.

Portola Pharmaceuticals develops innovative therapeutics based on targets with established proof of concept that are engineered to provide significant advances over current treatments for cardiovascular and inflammatory diseases and cancer.

Portola's two lead Phase II compounds, betrixaban, an oral Factor Xa inhibitor and PRT060128, an ADP receptor antagonist, target the global multi-billion dollar antithrombotic market. Both product candidates have best-in-class features versus current and novel agents in development and address the hospital, specialty, and chronic care markets. The Company's earlier-stage programs are leveraging its chemistry and kinase expertise to develop specific Syk and JAK inhibitors to treat cancer and inflammatory diseases with broader activity. The company also has a novel anticoagulant antidote program with the potential to help manage the more than 20 million patients expected to be treated with anticoagulants worldwide in the next decade. For additional information, visit http://www.portola.com.


'/>"/>
SOURCE Portola Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Portola Announces Data Presentations Relevant to Its Lead Phase II Antithrombotic Compounds at American Heart Association Scientific Sessions 2008
2. Portola Completes $60 Million Financing to Advance Its Therapeutic Programs
3. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
4. Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease
5. Raptor Pharmaceuticals Corp. Announces Positive Phase IIa Clinical Study Results for Convivia(TM) Program
6. Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
7. Diagenic Announces Launch of First Breast Cancer Gene-Expression Blood Test
8. VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
9. Celladon Announces Presentation of Clinical Data From First-in-Human MYDICAR(R) Trial for Advanced Heart Failure at American Heart Association Scientific Sessions
10. Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral Picoplatin
11. VIA Pharmaceuticals Announces Conference Call and Webcast to Discuss VIA-2291 Phase 2 Data Presentations at AHA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/17/2017)... , Feb. 17, 2017  Ethicon, Inc. today ... Inc., a privately held medical device company that ... Management System, a novel minimally invasive device for ... Torax Medical will enable Ethicon to offer patients ... laparoscopic Nissen fundoplication surgical procedure. 1 ...
(Date:2/17/2017)... 17, 2017 Research and Markets has announced the ... report to their offering. ... The report provides separate comprehensive analytics for the US, Canada ... Asia-Pacific , and Rest of World. Annual estimates and ... historic analysis is provided for these markets. Market data and analytics are ...
(Date:2/17/2017)... AMSTERDAM , Feb. 17, ... connected health offerings at the  ...  (NYSE: PHG,AEX: PHIA), a global ... a broad range of population ... personal health solutions, fully integrated in a ...
Breaking Medicine Technology:
(Date:2/18/2017)... ... February 18, 2017 , ... ... Use Pixel Film Studios ’ ProParagraph Fashion Volume 2 for all multi-line ... other applications. Users can pick and choose from hand-crafted trend-setting designs with ...
(Date:2/17/2017)... ... February 17, 2017 , ... Wells Pharmacy Network offers ... of controlled and non-controlled substances plus the ability to manage orders on their ... States now accept electronic prescriptions, according to the Office of the National Coordinator ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... been named a finalist in the 8th Annual DecisionHealth Platinum Awards in recognition ... system. Qualis Health’s work is recognized across multiple award categories, highlighting four of ...
(Date:2/17/2017)... ... February 17, 2017 , ... PrideStaff, a national staffing ... named to Staffing Industry Analysts' 2017 "Staffing 100 North America" list. , ... notable contributions to the staffing industry over the last twelve months. Industry insiders ...
(Date:2/17/2017)... ... 17, 2017 , ... Dillon Ruxton Insurance, a Florida-based agency ... in the greater Fort Lauderdale metropolitan region, is embarking on a cooperative food ... years, LifeNet 4 Families has provided a broad range of food provision services ...
Breaking Medicine News(10 mins):