Nuvelo Announces Results from Phase 3 NAPA Program in Acute Peripheral Arterial Occlusion
In the NAPA-2 clinical trial, the primary endpoint of 30-day open vascularsurgery avoidance was achieved in 34.9 percent of patients receivingalfimeprase, 37.2 percent of patients receiving intra-thrombus (IT) placebo,and 18.4 percent of patients receiving peri-thrombus (PT) placebo. An interimanalysis of the NAPA-3 study shows that 30-day open vascular surgery avoidancewas achieved in 29.4 percent of patients receiving alfimeprase and 17.6percent of patients receiving IT placebo. Efficacy data from subjects withlonger clots or smaller drops in alpha-2 macroglobulin, which rapidly andirreversibly inactivates alfimeprase, suggest improved retention ofalfimeprase at the site of the clot might improve lysis. Overall adverseevents (AE), as well as rates of hypotension and peripheral embolism, werenumerically higher among patients receiving alfimeprase in both studies.However, serious adverse events (SAE), major hemorrhage, cardiac events andinfections were higher in subjects receiving alfimeprase in NAPA-2, but werehigher in subject receiving IT placebo in NAPA-3. No intracranial hemorrhageswere reported in either study.
"We continue to believe that alfimeprase is an active thrombolytic agentwhen delivered in an optimized fashion, and we are focused on developingalfimeprase in stroke and catheter occlusion," said Michael Levy, M.D.,executive vice president of research and development for Nuvelo. "We continueto enroll patients in Phase 2 clinical trials in both these indications andexpect top-line data from the SONOMA-3 catheter occlusion trial in the firsthalf of 2008."
NAPA Phase 3 Program Details
The NAPA Phase 3 Program consisted of two randomized, double-blind studiesevaluating the efficacy and safety of 0.3 mg/kg of alfimeprase in patientswith acute PAO with symptom onset within 14 days. In NAPA-2, subjects wererandomized 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 betweenalfimeprase (n=51) and IT placebo (n=51). The primary endpoint of both studieswas avoidance of open vascular surgery within 30 days of treatment. A varietyof secondary endpoints were also evaluated, including restoration of arterialblood flow, safety endpoints such as the incidence of bleeding, andpharmacoeconomic endpoints such as length of hospital and intensive care unitstay.
Webcast Call Information
Nuvelo will hold a conference call Thursday, January 24th at 4:30 p.m.Eastern Time to discuss this presentation. To participate in the conferencecall, please dial 866-854-8095 for domestic callers and 706-634-8567 forinternational callers and reference conference passcode 31293129. A telephonereplay of the conference call will be available through Thursday, February 7,2008. To access the replay, please dial 800-642-1687 for domestic callers and706-645-9291 for international callers and reference conference passcode31293129.
In addition, this call is being webcast by Thomson/CCBN and can beaccessed via Nuvelo's website at http://www.nuvelo.com. The webcast is alsobeing distributed through the Thomson StreetEvents Network. Individuali
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