(Boursier.com) — Acticor Biotech has enrolled the 1st patient in the United States in its Actisave Phase 2/3 registrational study evaluating glenzocimab in patients with acute ischemic stroke. This first American patient was included at CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by Dr. Ruchir A. Shah.
Acticor had obtained an IND (Investigational New Drug Application) from the US Food and Drug Administration (FDA) for this study in November 2021, and had started recruiting in Europe in the third quarter of 2021. The study currently has 130 patients.
The clinical trial provides for 1,000 patients treated in approximately 80 centers in the United States, Europe (France, Germany, Belgium, Spain, Slovakia, Denmark, Czech Republic), Great Britain and Israel. A first futility analysis is planned after the inclusion of the first 200 patients to confirm the initial hypotheses.
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