Bristol-Myers Squibb (BMS) and Pfizer have started a new Phase 3 clinical trial to assess the effect of apixaban in patients with venous thromboembolism (VTE).
Apixaban, currently being developed by the two companies, is an investigational oral, highly selective factor Xa inhibitor, a new class of agents with therapeutic potential to prevent and treat blood clots.
The AMPLIFY (Apixaban after the initial Management of Pulmonary emboLIsm and deep vein thrombosis with First-line therapY) trials are part of the EXPANSE program-- the global Phase 3 clinical development trial program for apixaban, according to the companies.
AMPLIFY and AMPLIFY-EXT are two major clinical trials involving approximately 7,300 patients with deep vein thrombosis, the New York City-based Pfizer and the Princeton, N.J.-based BMS said.
“Current oral drug treatment options for the treatment of patients with VTE are primarily vitamin K antagonists (VKA), such as warfarin. Limitations of VKAs include a slow onset of action, a narrow therapeutic window necessitating regular coagulation monitoring and dose adjustment, and multiple food and drug interactions,” said Jack Lawrence, vice president of research and development of BMS.