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Portola Pharmaceuticals Initiates Phase II Trial Of Betrixaban, Its Novel Oral Factor Xa Inhibitor For Stroke Prevention In Atrial Fibrillation
Portola
Pharmaceuticals, a biopharmaceutical company developing innovative drugs
that provide significant advances in cardiovascular and inflammatory
diseases, and cancer, announced that it has begun patient enrollment
in a large Phase II clinical trial of betrixaban, the Company's novel oral
Factor Xa inhibitor anticoagulant, for stroke prevention in patients with
atrial fibrillation (SPAF).
"This is a major milestone achievement to advance the first of our two
highly differentiated Phase II product candidates that address the unmet
needs of the more than 50 million patients worldwide requiring hospital or
chronic antithrombotic therapy," said Charles Homcy, M.D., president and
chief executive officer of Portola. "Betrixaban's unique profile has the
promise to deliver reliable efficacy administered once-daily without the
excess bleeding associated with other anticoagulants."
The Phase II trial, called EXPLORE Xa, is a multi-national,
double-blind, dose-finding study that will enroll approximately 500
patients and assess three once-daily doses of betrixaban (40 mg, 60 mg, and
80 mg) administered for at least three months compared to dose-adjusted
warfarin (given open label), the current standard of care, in patients with
non-valvular atrial fibrillation. The goal of the study is to assess
long-term safety and tolerability of betrixaban and provide key dosing
information for Phase III studies. The Company expects to complete
enrollment of this trial by the end of 2009.
Potential Best in Class Therapy
"We are thrilled to have the opportunity to evaluate what we believe is
a truly unique anticoagulant in an exciting new class," said Stuart
Connolly, M.D., director of the Division of Cardiology at McMaster
University, Hamilton, Ontario, Canada, and principal investigator. "Because
betrixaban may provide predictable anticoagulation combined with a lower
risk of bleeding, and because it is minimally excreted in the kidneys,
betrixaban may be the only drug of its kind available for the large and
growing population of moderately and severely renally-impaired patients who
are at high risk for bleeding. This would dramatically expand the treatment
index for this type of drug."
Betrixaban has been specifically designed to have ideal properties for
chronic therapy and to be the only true, once-daily oral anticoagulant with
distinct advantages over other currently available anticoagulants or those
in clinical trials such as rivaroxaban, apixaban and dabigatran.
Betrixaban inhibits Factor Xa, a validated target for which there are
approved drugs on the market. Inhibiting Factor Xa activity appears to
offer advantages over other anticoagulation targets. Portola believes
betrixaban will offer several key differentiating features including a long
half-life and a low peak-to-trough drug concentration ratio to support
once-daily dosing and the potential for an improved benefit/risk profile.
Betrixaban is minimally excreted through the kidneys and therefore, unlike
other novel agents, may not require dose adjustment in patients with
moderately impaired renal function and may be the only novel oral
anticoagulant available for patients with severe renal disease. And because
betrixaban is neither an inhibitor nor an inducer of cytochrome P450
enzymes, it minimizes the risk of drug-drug interactions often seen with
other Factor Xa inhibitors in development and with warfarin.
Portola has completed EXPERT, a 200-patient Phase II trial,
demonstrating betrixaban's clinical proof of concept in preventing venous
thromboembolism in patients undergoing knee replacement surgery.
Preclinical and Phase I studies, in addition to EXPERT, have shown that
betrixaban is well tolerated over a range of dose levels.
Portola may develop betrixaban for additional indications including
prevention of venous thromboembolism (VTE) in medically ill patients and in
those undergoing major orthopedic surgery, treatment and secondary
prevention of VTE, and acute coronary syndromes (ACS).
About Atrial Fibrillation
Atrial fibrillation (AF) is a major cause of hospitalization and
mortality and affects about 2.5 million people in the United States, as
well as 4.5 million people in the European Union and is emerging as a
growing public health concern due to an aging population. In atrial
fibrillation, some blood inside the atria may stagnate, and clots may form.
If a piece of the clot breaks off and subsequently blocks an artery in the
brain, a stroke results. According to the joint ACC/AHA/ESC guidelines for
the management of atrial fibrillation, patients with atrial fibrillation
have a two- to seven-fold increased risk of stroke and also have an
increased risk of death and cardiovascular complications, including
myocardial infarction.
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,
addressing 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.
Portola Pharmaceuticals, Inc.
http://www.portola.com
View drug information on Warfarin Sodium tablets.
Portola Pharmaceuticals, faza a II-iniþiazã procesul Betrixaban, sa Novel oralã Factor Xa inhibitor Pentru Stroke Prevenirea În fibrilaþie atrialã - Portola Pharmaceuticals Initiates Phase II Trial Of Betrixaban, Its Novel Oral Factor Xa Inhibitor For Stroke Prevention In Atrial Fibrillation - articole medicale engleza - startsanatate