November 4th, 2021, Acticor Biotech issued a press release, which is summarized as follows:
ACTICOR BIOTECH today announces that the U.S Food and Drug Administration (FDA) has provided clearance for the initiation of a clinical trial in US with glenzocimab, a novel humanized monoclonal antibody fragment, for use in patients with acute ischemic stroke.
This active IND represents a significant milestone and marks the launch in the US of the Phase 2/3 clinical trial with glenzocimab in acute ischemic stroke as an add-on therapy to standard of care for this indication.
“The development of new therapeutic options for the treatment of the acute phase of ischemic stroke without increasing the bleeding risk, is a major medical need of the coming years. The FDA acceptance of an IND application for glenzocimab and the clinical program that will be conducted by Acticor Biotech in the US constitute important steps to offer new safe treatments to stroke patients” says Pr. James Grotta, M.D., Memorial Hermann Hospital, Texas Medical Center, Global Coordinating Investigator for ACTISAVE.
“We are very pleased with the achievement of this milestone which materializes our clinical objective stated at the time of our IPO which took place a few days ago, to enroll a first US patient in Q1 2022, following the enrollment of a first patient in Europe at the end of September 2021” concluded Gilles Avenard, Chief Executive Officer of Acticor Biotech. ACTISAVE (NCT05070260) is an adaptive Phase 2/3 multinational, randomized, double-blind, multicenter, placebo-controlled, parallel group, single dose, efficacy and safety study, where patients are randomized to either 1000mg glenzocimab or its matching placebo. Its primary objective is to evaluate the efficacy of glenzocimab in addition to standard of care, thrombolysis only or thrombolysis plus thrombectomy, with specific focus on the Day 90 modified Rankin Scale score (mRS), for acute ischemic stroke.
Started at the end of September 2021 in Europe, ACTISAVE follows the end of recruitment of ACTIMIS study, a phase 1b/2a dose escalation and safety study in 160 patients (NCT03803007), that permitted the selection of the recommended dose of 1000 mg and the confirmation of the favorable safety profile of glenzocimab (complete results are expected by the first quarter of 2022). Eight countries are expected to be involved with a total of 1000 patients. An initial futility analysis is planned after 200 patients have been enrolled.
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