Portola Pharmaceuticals, Inc. Announces Initiation Of Phase II Clinical Trial With Factor Xa Inhibitor
SOUTH SAN FRANCISCO, Calif., July 11 /PRNewswire/ -- Portola Pharmaceuticals, Inc. announced that it has initiated a Phase II clinical trial with its oral Factor Xa inhibitor for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing knee replacement surgery.
"The initiation of a Phase II trial with our lead product represents significant progress towards Portola's goal of developing next generation treatments for vascular diseases," said Charles Homcy, M.D., president and CEO of Portola. "We look forward to obtaining initial results from this trial in 2007."
"This candidate selectively inhibits Factor Xa, a validated target in the blood coagulation cascade, and may be applicable in the prevention and treatment of deep vein thrombosis, as well as in the prevention of strokes and heart attacks," stated Dan Gretler, M.D., Portola's vice president, clinical development and regulatory affairs. "Additionally, the unique properties of this compound may provide more consistent drug levels than other anticoagulants, with no need to monitor patients' blood for safety issues."
The multi-center, randomized, active-control study will evaluate the safety and efficacy of Portola's compound compared to LOVENOX(R) (enoxaparin sodium injection), a current standard of care for the prevention of DVT and PE, following knee replacement surgery. Relative safety and efficacy will be evaluated, with the primary efficacy endpoint defined as the absence of PE or DVT as determined by venogram. The study will be conducted at 20 sites in the United States and Canada under the guidance of Principal Investigator A. G. G. Turpie, M.D., of McMaster University in Hamilton, Ontario and other physicians with extensive clinical experience using anticoagulants.
"One of the troubling aspects of DVT is that about half of the time it is 'silent' and the first symptom may be a fatal pulmonary embolism," said Dr. Turpie. "Prevention of DVT is absolutely critical, and there is an unmet need for a drug that provides consistent performance and is available orally so patients can take it both in the hospital and after they are discharged. Portola has an exciting investigational compound that may address this need and improve our patient care options in this field."
In a Phase I clinical trial, the compound was well-tolerated at a wide range of doses. The drug has desirable pharmaceutical properties including a long half-life and high bioavailability, which Portola anticipates may translate to decreased variability and low peak-to-trough blood levels in patients.
About Portola's Factor Xa inhibitor:
The compound is an orally available small molecule that specifically and reversibly inhibits the formation of Factor Xa, a validated target and key enzyme for blood clot formation. The drug candidate has a rapid onset of action, providing a consistent anticoagulant effect without the need for coagulation monitoring. Portola's goal is to develop an oral drug for several major indications, including the prevention and treatment of deep vein thrombosis and pulmonary embolism, stroke prevention in atrial fibrillation, and secondary prevention of stroke and myocardial infarction.
Deep Vein Thrombosis (DVT)
DVT is a potentially life threatening condition that occurs when blood clots form in the veins, typically within the leg. A report from the National Heart, Lung and Blood Institute estimates that 250,000 people are diagnosed with DVT each year, but the number of people at risk for DVT is much higher, including anyone who undergoes orthopedic, abdominal or general surgery or prolonged hospitalization. The American Association of Orthopaedic Surgeons estimates that more than 6.5 million orthopedic surgeries are performed each year. In approximately 30% of DVT patients, the clot breaks off and becomes lodged in the lung, resulting in pulmonary embolism (PE), a potentially fatal condition.
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. We are conducting a Phase II clinical trial with our oral Factor Xa inhibitor for the prevention of deep vein thrombosis, and a Phase I clinical program with our 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: Carol Olson of Portola Pharmaceuticals, +1-650-246-7000, orcolson@portola.com; or Trista Morrison of Porter Novelli Life Sciences,+1-858-527-3490, or tmorrison@pnlifesciences.com, for PortolaPharmaceuticals
Web site: http://www.portola.com/