CNS Pharmaceuticals enrolls 229 of expected 243 patients in berubicin study

CNS Pharmaceuticals has achieved enrollment of 229 of the expected 243 patients in the ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer. The Company has opened 46 clinical trial sites across the U.S., Italy, France, Spain, and Switzerland. As previously announced, CNS Pharmaceuticals has reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board will review to determine whether to recommend continuing the study as planned or modifying the study based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma. CNS Pharmaceuticals previously reported that the Company would conduct this analysis after at least 50% of the patients in the population to be analyzed for the interim analysis had reached the primary efficacy endpoint, as provided for in the study protocol. The DSMB will review the number of deaths in each arm to ensure that the overall survival of patients receiving Berubicin shows at least a statistically significant comparability to those receiving Lomustine. Additional analyses will include comparisons of secondary endpoints, including progression-free survival response rates, and safety assessments. Upcoming Expected Milestones: Report topline results of interim analysis expected in Q4 2023. Enrollment will continue during the interim analysis.Complete enrollment in Q4 2023.