Nuvelo has enrolled the first patient in a Phase III trial evaluating the efficacy of its lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion.
Known as SONOMA-2 (Speedy Opening of Non-Functional and Occluded Catheters with Mini-Dose Alfimeprase), the trial is one of two overlapping, multinational trials in Nuvelo's alfimeprase program for catheter occlusion. The randomized, double-blind study compares the efficacy of 3 mg of alfimeprase with placebo in 300 patients with occluded central venous catheters. Two-thirds of the participants will receive alfimeprase and the remainder will receive placebo. The primary endpoint of the study is restoration of catheter function within 15 minutes. The second study in the Phase III program, called SONOMA-3, is an open-label, single-arm trial evaluating the safety and efficacy of alfimeprase in 800 patients.