Shares of Nuvelo Inc. (Nasdaq: NUVO) spiked up today after releasing its Phase III news earlier this morning. In early trading, NUVO was up 12 cents (7 percent) to $1.75 per share on volume of just over 372,000 shares.
NUVO 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 III 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 III 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 VP of research and development for NUVO, in a statement. “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, more concentrated dose and expect data from this trial in 2008.”
NUVO is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. NUVO expects to leverage its expertise in cancer antibody discovery to further expand its pipeline and create additional partnering and licensing opportunitie
