Portola moves oral anticoagulant into clinical trials

If successfully developed, the product would address the multi-billion dollar market opportunity for the prevention and treatment of venous thrombosis and for the prevention and treatment of thromboembolic complications in patients with atrial fibrillation and in patients who have had a myocardial infarction (heart attack).

The product candidate is an oral Factor Xa inhibitor. Factor Xa, the enzyme responsible for converting prothrombin to thrombin, is a validated and attractive pharmacologic target for a new anticoagulant. Thrombin plays a key role in arterial and venous thrombosis, activating both platelets and the coagulation process. By stopping the coagulation cascade at an early step, inhibition of Factor Xa could effectively inhibit thrombus formation.

“This is a major milestone for our business as we move to a clinical-stage development organization,” said Dr Charles Homcy, president and CEO of Portola Pharmaceuticals. “There is a tremendous need for a next generation oral anticoagulant. We are attempting to overcome the limitations of the only approved oral anticoagulant, Coumadin, and create a product with better safety and efficacy that will eliminate the need to persistently monitor and adjust dosing.”

Coumadin (warfarin) is marketed by Bristol-Myers Squibb. Warfarin must be managed closely because too much of the drug can cause bleeding, and too little can cause a stroke. Maintaining the proper range is difficult for most people and requires monthly testing at a laboratory or clinic.