Nuvelo Resumes SONOMA-3 Trial of Alfimeprase

Nuvelo announced enrollment of the first patient in the Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-3 (SONOMA-3) trial evaluating alfimeprase for the treatment of central venous catheter occlusion.

This open-label, single-arm trial will evaluate the safety and efficacy of a single 10 mg dose of alfimeprase with a concentration of 5 mg/mL in a maximum of 100 patients.

Michael Levy, Nuvelo’s executive vice president of R&D, said data from the company’s previous Phase III SONOMA study provided evidence that alfimeprase is an active thrombolytic with the potential to dissolve clots and restore catheter function. However, the dose and concentration used in the study did not generate results in line with the target product profile.

Preclinical experiments provided evidence that increasing the concentration can result in improved thrombolytic activity, Levy added. The company will resume development of the candidate to evaluate the potential of a higher, more concentrated dose and expects trial data in 2008.