Nuvelo gets FDA agreement on SPA for phase 3 alfimeprase trial in acute peripheral arterial occlusion

By E. Janene Geiss

Philadelphia, Dec. 14 - Nuvelo Inc. announced Wednesday that it has received a Special Protocol Assessment agreement from the Food and Drug Administration for its second pivotal phase 3 trial, Novel Arterial Perfusion with Alfimeprase-3 (NAPA-3).

This trial will evaluate the efficacy and safety of Nuvelo's lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion or "leg attack," according to a company news release.

"We have worked closely with the FDA on the design of the NAPA program as a whole and are pleased to have secured an SPA for this pivotal trial," said Michael D. Levy, senior vice president of research and development, in the release.

The company said it began enrolling patients in its NAPA-2 trial, its first alfimeprase phase 3 trial in acute peripheral arterial occlusion in April, and is focused on beginning the NAPA-3 study in early 2006.

"Although the process of securing the SPA has slightly delayed the start of NAPA-3, we are pleased to have this agreement in place as it solidifies the regulatory pathway to approval for alfimeprase," Levy said.

NAPA-3 will be a randomized, double-blind study comparing 0.3 mg of alfimeprase to placebo in 300 patients, officials said.

The trial will be conducted in about 100 centers worldwide with the primary endpoint of avoidance of open vascular surgery within 30 days of randomization. Open vascular surgery includes procedures such as surgical embolectomy, peripheral arterial bypass graft surgery or amputation but does not include catheter-based procedures such as percutaneous angioplasty or stenting, officials said.

A variety of secondary and exploratory endpoints also are being evaluated, including safety endpoints such as incidence of bleeding and pharmacoeconomic endpoints such as length of hospital stay and total time in the intensive care unit, officials said.

Acute peripheral arterial occlusion or "leg attack" is the blocking of arterial blood flow to a lower limb by a blood clot. Affecting more than 100,000 people in the United States each year, acute peripheral arterial occlusion is the result of underlying peripheral arterial disease in which chronic fatty plaque buildup restricts blood flow and is then complicated by the formation of an acute clot. If blood flow is not restored quickly, leg attack can lead to permanent nerve and muscle damage, gangrene and in the most severe cases, amputation and death.

In clinical studies, alfimeprase has been shown to have the ability to degrade large arterial clots within four hours of initiation of dosing, as well as the ability to clear a majority of occluded catheters in 15 minutes or less, officials said.

Nuvelo, based in San Carlos, Calif., is dedicated to improving the lives of patients through the development and commercialization of novel drugs for acute cardiovascular and cancer therapy.

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