Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase D...( -Webcast to Be Held ...),Health

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SAN CARLOS, Calif., March 17 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced that data from the Phase 2 program in catheter occlusion (CO), known as SONOMA-3 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase), did not show sufficient improvement in catheter opening at the higher dose and concentration evaluated in the study to meet the desired target product profile. As a result, Nuvelo has ended further clinical development of alfimeprase including its programs in CO and acute ischemic stroke.

In the open-label, single-arm, SONOMA-3 trial, alfimeprase restored catheter function in approximately 50 percent of patients at 15 minutes and approximately 60 percent of patients at one hour. While the 15-minute clearance rate represents an improvement over the previous Phase 3 SONOMA-2 trial, which evaluated a lower dose and concentration of alfimeprase than the SONOMA-3 trial, the clearance rate at one hour fell short of the company's expectations. Cathflo(R)Activase(R), the product currently on the market for catheter occlusion, has been shown to restore catheter function in more than 80 percent of occluded catheters within two to four hours.

"The value proposition for alfimeprase in CO was to restore catheter function with similar efficacy to CathfloActivase, but in a much shorter time frame. We did not see the robust increase in activity or dose response expected with the significantly increased dose and concentration we tested in the SONOMA-3 trial," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "We have conducted high-quality, comprehensive development of alfimeprase and are confident
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