Portola deep vein thrombosis drug begins mid phase trial

The multi-center study will evaluate the safety and efficacy of Portola’s compound compared to Sanofi-Aventis’ Lovenox, a current standard of care for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), following knee replacement surgery.

“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 Dr Dan Gretler, Portola’s vice president of 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.”

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.