CNSP - Switzerland approves CNS Pharma's berubicin study in brain cancer

CNS Pharmaceuticals (NASDAQ:CNSP) has received approval from swissethics, the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, for its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), a type of brain cancer. Shares up 6.6% premarket at $1.13. Approx. 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. A pre-planned, non-binding futility analysis will be performed after approx. 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis. In June 2021, FDA granted Fast Track designation to berubicin for the treatment of recurrent GBM.

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Switzerland approves CNS Pharma's berubicin study in brain cancer