Portola Pharma Announces Publication Of Phase 3 APEX Study Design - Quick Facts

(RTTNews) - Portola Pharmaceuticals (PTLA) announced publication of the design and rationale of the Phase 3 APEX or Acute Medically Ill VTE Prevention with Extended Duration Betrixaban Study in the March 2014 issue of the American Heart Journal.

Betrixaban, the company's wholly-owned, oral, once-daily Factor Xa anticoagulant, is being evaluated in the only ongoing global, pivotal study of in-hospital and post-discharge prevention of venous thromboembolism or VTE, or blood clots, in patients who have been hospitalized for medical conditions, such as heart failure, stroke, infection and pulmonary disease.

The prospective, randomized, double-blind, multicenter, multinational APEX Study is evaluating the superiority of extended-duration anticoagulation with oral betrixaban (for up to 35 days in hospital and post-discharge) compared with standard of care anticoagulation with injectable enoxaparin (for 10 days) for VTE prevention in acute medically ill patients. The study will enroll close to 7,000 patients at more than 425 study sites worldwide.

The primary efficacy endpoint is the composite of asymptomatic proximal deep venous thrombosis, symptomatic deep venous thrombosis, non-fatal pulmonary embolism or VTE-related death through day 35. The primary safety outcome is the occurrence of major bleeding.

Acute medically ill patients, who are at high risk for developing blood clots, are hospitalized due to a serious medical condition such as heart failure, stroke, infection, pulmonary disease or rheumatic disease. They are often elderly, frail, renally compromised and taking multiple concomitant medications.