Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter...( - Revised Trial Examines Single ...),Health

- Revised Trial Examines Single, Higher, More Concentrated Dose of

Alfimeprase -

SAN CARLOS, Calif., Aug. 22 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced enrollment of the first patient in the SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-3) trial evaluating lead product candidate, alfimeprase, for the treatment of central venous catheter occlusion (CO).

This open-label, single-arm trial will evaluate the safety and efficacy of a single 10 milligram dose of alfimeprase with a concentration of 5 milligrams per milliliter in up to 100 patients with occluded central venous catheters.

Data from a previous Phase 3 trial in the CO program, SONOMA-2, showed that alfimeprase restored catheter function in patients with occluded catheters within 15 minutes with a p-value of 0.022. It did not however, meet the more stringent p-value required for a single pivotal trial, less than 0.00125.

"Analysis of data from our previous Phase 3 SONOMA study provided further evidence that alfimeprase is an active thrombolytic which has the potential to dissolve clots quickly and rapidly restore catheter function, however, the dose and concentration we used did not generate results in line with the target product profile we believe necessary for commercial success in this market," said Michael Levy, M.D., executive vice president of research and development for Nuvelo. "Preclinical experiments have provided evidence that increasing the concentration can result in marked improvement in thrombolytic activity. Accordingly, we are resuming development of alfimeprase in CO to evaluate the potential of a single, higher, m
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