Bayer HealthCare and Nuvelo begin second pivotal phase III trial of lead product candidate, alfimeprase

01-Mar-2006

Bayer HealthCare and Nuvelo Inc. announced that they have begun patient enrollment in a second pivotal phase III clinical trial of lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion (CO). Alfimeprase is a novel thrombolytic or blood clot dissolver.

The phase III trial, known as SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-3), is the second of two overlapping, multi-national trials in the phase III alfimeprase program for CO. This open-label, single-arm trial will evaluate the safety and efficacy of 3 mg of alfimeprase in 800 patients with occluded central venous catheters.

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 alfimeprase. Under the terms of the agreement, Bayer will commercialize alfimeprase in all territories outside the United States.

Previously announced results from a phase II multi-center, randomized, double-blind study in 55 patients with occluded central venous catheters demonstrated that alfimeprase restored flow to 40 percent and 50 percent of occluded catheters 5 and 15 minutes after the first dose, respectively. By comparison, Cathflo®Activase® (alteplase) did not restore flow at either time point. Alfimeprase also restored flow to 60 percent of occluded catheters at 120 minutes after the first dose and to 80 percent of occluded catheters at 120 minutes after the second dose compared with 46 percent at 120 minutes after the first dose and 62 percent at 120 minutes after the second dose with Cathflo®Activase®.

https://www.bionity.com/en/news/52632/bayer-healthcare-and-nuvelo-begin-second-pivotal-phase-iii-trial-of-lead-product-candidate-alfimeprase.html