Nuvelo Announces Results From NAPA Trial In Acute Peripheral Arterial Occlusion
Nuvelo announced results from the Phase 3 NAPA (Novel Arterial Perfusion with Alfimeprase) program evaluating alfimeprase in acute peripheral arterial occlusion (PAO).
Alfimeprase is the company's lead product candidate and is currently being studied in acute ischemic stroke and catheter occlusion (CO). The NAPA data were presented in a poster session by Fred Weaver, M.D., professor of surgery and associate director of the University of Southern California Cardiovascular and Thoracic Institute, at the 2008 International Symposium on Endovascular Therapy (ISET), taking place this week in Hollywood, FL. A webcast will be held today, January 24, at 4:30 p.m. ET to review these data.
In the NAPA-2 clinical trial, the primary endpoint of 30-day open vascular surgery avoidance was achieved in 34.9 percent of patients receiving alfimeprase, 37.2 percent of patients receiving intra-thrombus (IT) placebo, and 18.4 percent of patients receiving peri-thrombus (PT) placebo. An interim analysis of the NAPA-3 study shows that 30-day open vascular surgery avoidance was achieved in 29.4 percent of patients receiving alfimeprase and 17.6 percent of patients receiving IT placebo.
Efficacy data from subjects with longer clots or smaller drops in alpha-2 macroglobulin, which rapidly and irreversibly inactivates alfimeprase, suggest improved retention of alfimeprase at the site of the clot might improve lysis. Overall adverse events (AE), as well as rates of hypotension and peripheral embolism, were numerically higher among patients receiving alfimeprase in both studies. However, serious adverse events (SAE), major hemorrhage, cardiac events and infections were higher in subjects receiving alfimeprase in NAPA-2, but were higher in subject receiving IT placebo in NAPA-3. No intracranial hemorrhages were reported in either study.
"We continue to believe that alfimeprase is an active thrombolytic agent when delivered in an optimized fashion, and we are focused on developing alfimeprase in stroke and catheter occlusion," said Michael Levy, M.D., executive vice president of research and development for Nuvelo. "We continue to enroll patients in Phase 2 clinical trials in both these indications and expect top-line data from the SONOMA-3 catheter occlusion trial in the first half of 2008."
NAPA Phase 3 Program Details
The NAPA Phase 3 Program consisted of two randomized, double-blind studies evaluating the efficacy and safety of 0.3 mg/kg of alfimeprase in patients with acute PAO with symptom onset within 14 days. In NAPA-2, subjects were randomized in a 4:3:1 ratio to receive IT alfimeprase (n=149), IT placebo (n=113), or PT placebo (n=38). In NAPA-3, subjects were randomized 1:1 between alfimeprase (n=51) and IT placebo (n=51). The primary endpoint of both studies was avoidance of open vascular surgery within 30 days of treatment. A variety of secondary endpoints were also evaluated, including restoration of arterial blood flow, safety endpoints such as the incidence of bleeding, and pharmacoeconomic endpoints such as length of hospital and intensive care unit stay.