CNS Pharmaceuticals Begins Enrollment, Screening Brain Cancer Study With Berubicin

CNS Pharmaceuticals Inc CNSP has opened enrollment for its Phase 2 study evaluating its lead candidate, Berubicin, for recurrent Glioblastoma Multiforme (GBM).
The company intends to enroll approximately 210 subjects.
The trial includes adult patients with recurrent glioblastoma multiforme after the failure of standard first-line therapy.
The primary endpoint of the study is Overall Survival.
Results from the trial will compare Berubicin to the current standard of care (Lomustine).
A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at six months.
Additionally, the company's sublicensee partner in Poland, WPD Pharmaceuticals, will initiate Berubicin Phase 2 trial in adult GBM in the second half of 2021 and a Phase 1 trial in pediatric gliomas in 2021.
The WPD trial will include an interim analysis of the first 18 patients in the first half of 2022 for efficacy and safety, and pharmacokinetic profile.
Price Action: CNSP shares are down 3.2% at $1.82 on the last check Wednesday.