Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ische...( SAN CARLOS Calif. Dec. 12 /- Nuve...),Health

SAN CARLOS, Calif., Dec. 12 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced dosing of the first patient in a Phase 2 proof-of-concept trial of alfimeprase for the treatment of acute ischemic stroke.

Nuvelo has also been granted fast track designation by the U.S. Food and Drug Administration (FDA) for alfimeprase in this indication. Fast track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate expedited review of a Biologics License Application (BLA). Fast track designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.

The Phase 2 CARNEROS-1 (Catheter Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke) proof-of-concept trial is a multi-center, open-label, two part, dose escalation (1 mg, 5 mg and 10 mg) study that will enroll approximately 100 patients within 3-9 hours of stroke onset. CARNEROS-1 is designed to evaluate the safety and efficacy of intra-arterial, catheter-directed, bolus alfimeprase. The primary efficacy endpoint is recanalization, or unblocking, of the primary arterial occlusive lesion within 120 minutes of treatment with alfimeprase. Safety will be assessed, including the rate of symptomatic intracerebral hemorrhages at 24 hours.

"We believe that a safer, more efficacious intra-arterial therapy can change the treatment paradigm for stroke patients and that a product candidate such as alfimeprase holds the potential to restore flow rapidly and expand the current treatment window for this underserved patient population," said Michael Levy, M.D., executive vice preside
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