CNS Pharmaceuticals Begins Enrollment, Screening Brain Cancer Study With Berubicin
- CNS Pharmaceuticals Inc (NASDAQ: 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.
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