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news.Nuvelo has started dosing of the first patient in a Phase II proof-of-concept trial of alfimeprase for the treatment of acute ischemic stroke. Nuvelo has also been granted Fast Track designation by the FDA for alfimeprase in this indication.
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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 II 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 (1mg, 5mg and 10mg) study that will enroll approximately 100 patients within 3-9 hours of stroke onset. The study is designed to evaluate the safety and efficacy of intra-arterial, catheter-directed, bolus alfimeprase.
Michael Levy, executive vice president of R&D for Nuvelo, said: “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.”