Portola Pharmaceuticals, Inc. Advances ADP Program: Initiates Phase I Trial With IV Formulation, Trials With Oral Formulation Ongoing
SOUTH SAN FRANCISCO, Calif., Oct. 31 /PRNewswire-FirstCall/ -- Portola Pharmaceuticals, Inc. announced that it has initiated a Phase I clinical trial in healthy volunteers with the intravenous (IV) formulation of its ADP receptor antagonist, an antiplatelet agent being studied for cardiovascular indications. Portola recently completed its first Phase I study in healthy volunteers in which the oral formulation of the same compound was found to be well tolerated and showed dose-dependent platelet inhibition. Portola's compound is believed to be the only ADP receptor antagonist with both IV and oral formulations currently in clinical development.
"Our compound's unique properties could significantly improve the way physicians manage patients with acute coronary syndromes (ACS) and other thrombotic diseases by overcoming the limitations of the antiplatelet drug Plavix(R), which also targets the ADP receptor," said Dan Gretler, M.D., Portola's vice president, clinical development and regulatory affairs. "Plavix is only available in an oral formulation and is further limited by its slow onset of action, variable response and irreversible platelet inhibition."
Potential indications for this antiplatelet compound include the prevention of heart attack and death in patients with ACS, prevention of thrombotic events following percutaneous coronary intervention (PCI) and stent placement, and prevention of secondary thrombotic events such as heart attack and stroke in patients with a history of these conditions. According to IMS Health, Plavix was the number two selling drug worldwide in 2005, with approximately $6 billion in sales.
"The initiation of this second Phase I clinical trial with our ADP program represents significant progress towards Portola's goal of developing the next generation of anti-thrombotics," said Charles Homcy, M.D., president and CEO of Portola. "We look forward to initiating a Phase II clinical trial studying the IV and oral formulations in ACS patients in 2007."
About Portola's ADP Receptor Antagonist
Portola is developing oral and IV formulations of a small molecule inhibitor of the ADP receptor on platelets to block aggregation. Portola believes IV and oral formulations of the same molecule are important to allow cardiologists to seamlessly transition from acute treatment to chronic therapy. If approved by the Food and Drug Administration, Portola's ADP product candidate could address the limitations of Plavix, the current standard of care for patients with ACS and secondary prevention of thrombotic events in post-myocardial infarction and stroke patients. Unlike Plavix, Portola's ADP product candidate can achieve immediate, high-level platelet inhibition with an IV formulation appropriate for acute treatment, while also providing predictable platelet inhibition in the chronic setting. Both formulations of the compound are reversible, which should allow for surgery without significant delay following treatment.
About Portola
Portola Pharmaceuticals, Inc. is a private biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapeutics for acute and chronic cardiovascular and vascular disease. Portola is conducting a Phase II clinical trial with its oral Factor Xa inhibitor for the prevention of deep vein thrombosis, and a Phase I clinical program with its direct-acting, oral and IV ADP receptor antagonist. These drug candidates could potentially advance patient care in the $14 billion anti-thrombotics market. Portola also has a robust drug discovery platform focusing on the platelet and signaling pathways that mediate thrombosis and inflammation. Portola's investors include Abingworth, Alta Partners, ATV, Frazier Healthcare Ventures, MPM Capital, Prospect Ventures and Sutter Hill Ventures.
Portola Pharmaceuticals, Inc.CONTACT: Trista Morrison of Porter Novelli Life Sciences, +1-858-229-1738,or tmorrison@pnlifesciences.com
Web site: http://www.portola.com/