Nuvelo Announces Design of Phase III Alfimeprase Program

Nuvelo has finalized the design of the Phase III program for its lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion.

The Phase III program, known as SONOMA (Speedy Opening of Non-Functional and Occluded Catheters with Mini-Dose Alfimeprase), includes two overlapping, multinational trials.

The first trial is an efficacy study called SONOMA-2. This study is a randomized, double-blind trial, comparing 3 mg of alfimeprase with placebo in 300 patients with occluded central venous catheters. Two-thirds of the patients will receive alfimeprase and the remainder will receive placebo. The study's primary endpoint is restoration of function to occluded central venous catheters at 15 minutes.

The safety study, SONOMA-3, will be an open-label, single-arm trial evaluating alfimeprase alone in 800 patients.