BMS and Pfizer initiate new apixaban study

Bristol-Myers Squibb (BMS) and Pfizer have announced the start of a new study as part of the phase III clinical trial programme for apixaban.

The first patient has been dosed on the year-long study which will examine the effects of the compound on patients with blood clots in the leg veins or lungs.

Apixaban is an investigational orally-administered highly selective factor Xa inhibitor currently being developed by BMS and Pfizer.

The Amplify trial is part of the phase III Expanse programme and will enrol around 4,800 patients with acute deep vein thrombosis or pulmonary embolism and will assess the safety an efficacy of apixaban compared to enoxaparin plus warafin.

Jack Lawrence, vice-president of research and development at BMS, said: “The initiation of this apixaban phase III trial represents BMS’s and Pfizer’s commitment to furthering research in the treatment of venous thromoboembolism, a serious disease that affects 1.3 million people annually in the US and Europe.”

He added that existing orally-administered treatments are mainly vitamin K antagonists and have drawbacks including a narrow therapeutic window, food and drug interactions and slow onset of action.

BMS and Pfizer signed a gobal partnership agreement for the development and commercialisation of apixaban in April 2007, with Pfizer paying an initial fee of $250 million (125.4 million pounds) plus 60 per cent of development costs backdated to the start of the year.