Bayer HealthCare and Nuvelo begin second pivotal phase III trial of alfimeprase
Bayer HealthCare (BHC) and Nuvelo Inc. announced that they had begun patient enrollment in a second pivotal phase III clinical trial of alfimeprase for the treatment of acute peripheral arterial occlusion (PAO). This phase III trial, known as NAPA-3 (Novel Arterial Perfusion with Alfimeprase-3), recently received a Special Protocol Assessment (SPA) agreement from the U.S. food and Drug Administration (FDA). An SPA is a written agreement on the design and size of clinical trials intended to form the basis for a new drug application.
In January 2006 Bayer HealthCare AG (BHC) and Nuvelo Inc. announced that they entered into a collaboration agreement for the global development and commercialization of the novel thrombolytic or blood clot dissolver alfimeprase. Under the terms of the agreement, Bayer will commercialize alfimeprase in all territories outside the United States.
NAPA-3 is the second of two overlapping multi-national trials in the phase III alfimeprase program for acute PAO. Both trials are randomized, double-blind studies comparing 0.3 mg/kg of alfimeprase with placebo in a total of 600 patients between the two studies. The primary endpoint in both trials is avoidance of open vascular surgery within 30 days of treatment. A variety of secondary endpoints are also being evaluated in the two trials, including safety endpoints, such as the incidence of bleeding, and pharmacoeconomic endpoints, such as length of hospital and intensive care unit (ICU) stay.
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