CNS Pharmaceuticals reaches enrollment of 200 patients in berubicin study

CNS Pharmaceuticals announced that 200 of the expected 243 patients have now been enrolled in the Company’s ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer. This potentially pivotal, global study of Berubicin is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM after failure of standard first-line therapy and compared to Lomustine as the standard of care. The primary endpoint of the study is Overall Survival, a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. The Company has opened 46 clinical trial sites of the approximately 60 sites selected 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. The Company is confident it will announce the results from the interim analysis publicly before the year end. Enrollment will continue during the interim analysis.