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Portola Announces Initiation Of Phase II Clinical Trial With Factor Xa Inhibitor
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.
http://www.portola.com
Portola anunþã iniþierea studiului clinic de fazã II cu factorul Xa inhibitor - Portola Announces Initiation Of Phase II Clinical Trial With Factor Xa Inhibitor - articole medicale engleza - startsanatate