CNSP - CNS Pharmaceuticals commences patient enrollment in berubicin brain cancer study
CNS Pharmaceuticals (CNSP) announces open enrollment for its potentially pivotal study evaluating the efficacy and safety of berubicin in the treatment of recurrent glioblastoma multiforme ((GBM)), an aggressive and incurable form of brain cancer.The company intends to enroll about 210 subjects across 35 clinical sites in the U.S. and also plans to expand the trial into western Europe.The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy, with the primary endpoint of overall survival.Results from the trial will compare berubicin to the current standard of care, with a 2 to 1 randomization of patients to receive either berubicin or lomustine.In addition to the global trial, sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a Phase 2 multicenter clinical trial of berubicin in adult GBM in the second half of 2021 as well as a Phase 1 multicenter
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CNS Pharmaceuticals commences patient enrollment in berubicin brain cancer study