Nuvelo receives FDA fast track status, begins Phase 2 trial for stroke drug
Nuvelo has announced the dosing of the first patient in a Phase 2 proof-of-concept trial of alfimeprase for the treatment of acute ischemic stroke.
Alfimeprase is a recombinant direct acting fibrinolytic that has the potential to rapidly dissolve blood clots through a unique mechanism of action, it degrades fibrin, a protein that provides the scaffolding for blood clots, according to Nuvelo.
The company said that the FDA has granted fast track designation for its alfimeprase in the indication. Fast track designation, mandated by the FDA Modernization Act of 1997, can facilitate expedited review of a biologics license application. 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, Nuvelo said.
The Phase 2 Catheter Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke (CARNEROS)-1 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.
The San Carlos, Calif.-based Nuvelo said 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. The safety will be assessed, including the rate of symptomatic intracerebral hemorrhages at 24 hours.
Lawrence Wechsler, MD, professor of neurology and neurological surgery at the University of Pittsburgh Medical School and director of the University of Pittsburgh Medical Center Stroke Institute, said that there “is a need for new and more effective approaches to stroke therapy for patients who present more than three hours after onset of symptoms Alfimeprase could be well suited for this particular setting as it is a clot-dissolver that holds the potential to directly and rapidly dissolve blood clots while keeping its activity localized to the site of delivery.”
Alfimeprase is a recombinant direct acting fibrinolytic that has the potential to rapidly dissolve blood clots through a unique mechanism of action, it degrades fibrin, a protein that provides the scaffolding for blood clots, according to Nuvelo.
The company said that the FDA has granted fast track designation for its alfimeprase in the indication. Fast track designation, mandated by the FDA Modernization Act of 1997, can facilitate expedited review of a biologics license application. 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, Nuvelo said.
The Phase 2 Catheter Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke (CARNEROS)-1 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.
The San Carlos, Calif.-based Nuvelo said 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. The safety will be assessed, including the rate of symptomatic intracerebral hemorrhages at 24 hours.
Lawrence Wechsler, MD, professor of neurology and neurological surgery at the University of Pittsburgh Medical School and director of the University of Pittsburgh Medical Center Stroke Institute, said that there “is a need for new and more effective approaches to stroke therapy for patients who present more than three hours after onset of symptoms Alfimeprase could be well suited for this particular setting as it is a clot-dissolver that holds the potential to directly and rapidly dissolve blood clots while keeping its activity localized to the site of delivery.”