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Bristol-Myers, Pfizer begin phase 3 trial of apixaban
New York | Thursday, June 12, 2008, 08:00 Hrs  [IST]

Bristol-Myers Squibb and Pfizer have started a new phase 3 clinical trial to assess the effect of apixaban in patients with venous thromboembolism (VTE), a potentially fatal disease process that begins with blood clots in the leg veins or lungs.

Apixaban, which is 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 apixaban after the initial management of pulmonary embolism and deep vein thrombosis with first-line therapy (Amplify) trials are part of the global phase 3 clinical development trial programme for apixaban. Amplify and apixaban after the initial management of pulmonary embolism and deep vein thrombosis with first-line therapy extended treatment (Amplify-EXT) are two major clinical trials involving approximately 7,300 patients with deep vein thrombosis (DVT), a blood clot in the vein, or pulmonary embolism (PE), a potentially fatal condition caused by a blood clot blocking a vessel in the lung.

"The initiation of this apixaban phase 3 trial represents Bristol-Myers Squibb's and Pfizer's commitment to furthering research in the treatment of VTE, a serious disease that affects 1.3 million people annually in the US and Europe," said, Jack Lawrence, vice president, research and development, Bristol-Myers Squibb.

"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," he added.

The Amplify-EXT trial has initiated enrolment and will include approximately 2,430 patients who will receive apixaban 2.5 mg dose or 5 mg twice daily for an extended 12-month period compared to patients taking placebo to determine the effects of apixaban on recurrent VTE. Prior to entering the trial, patients will have completed 6 to 12 months of treatment for DVT or PE.

The Amplify trial is expected to begin in the next few months, and would enrol approximately 4,800 patients with acute DVT or PE. The trial will investigate the safety and efficacy of apixaban 10 mg twice daily for 1 week followed by 5 mg twice daily for 6 months compared to enoxaparin plus warfarin, the two drugs used as the current standard of care.

The expanse apixaban clinical trial programme has seven ongoing phase III clinical studies involving approximately 45,000 patients worldwide. In addition to the recently initiated VTE treatment programme, the expanse programme also includes trials studying potential use for prevention of venous thromboembolism in patients undergoing orthopaedic surgery and in hospitalised medically ill patients at high risk of VTE, and trials studying prevention of stroke and other thromboembolic events in patients with atrial fibrillation (AF).

Apixaban has also recently completed enrolment in a phase II trial in patients with acute coronary syndrome (the APPRAISE trial). The results of this trial will be presented at the European Society of Cardiology meeting in September 2008.

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