Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
- 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, more concentrated dose and expect data from this trial in 2008.'
About Catheter Occlusion
Delivery of chemotherapy, nutritional support, antibiotics and blood products, as well as the frequent withdrawal of blood samples for laboratory testing, are often facilitated via central venous catheters. Approximately five million catheters are placed in patients in the United States each year, with as many as 25 percent becoming occluded. When a catheter becomes occluded, the goal is to restore flow in a prompt and cost-effective manner with minimal risk to the patient. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter as soon as possible. In the case of thrombotic occlusions, treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement.
About Alfimeprase
Alfimeprase is a recombinant direct acting fibrinolytic (rDAF) that has the potential to rapidly dissolve blood clots through a unique mechanism of action -- it directly degrades fibrin, a protein that provides the scaffolding for blood clots. In addition, alfimeprase's thrombolytic activity appears to be localized to the site of delivery because it is rapidly inactivated by alpha-2 macroglobulin, a naturally occurring protein in the blood, as it moves away from the site of delivery and into the general blood circulation.
In addition to catheter occlusion, alfimeprase is also being evaluated as a potential treatment for acute ischemic stroke and is in preclinical studies for acute peripheral arterial occlusion.
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