CNS Pharmaceuticals provides trial update for ongoing berubicin study

CNS Pharmaceuticals provided a clinical update for its ongoing clinical 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. Enrollment Update – Full Enrollment of the Potentially Pivotal Study Expected by Year End: The Company has opened 46 clinical trial sites of the approximately 60 sites selected across the U.S., Italy, France, Spain, and Switzerland. The Company is announcing today that the first clinical trial site in Italy has been activated and the enrollment and dosing of the first patient in Italy has taken place. To date, 180 patients of the expected 243 patients have been enrolled in the study. Recent Enrollment Highlights: Reached 74% enrollment in study; Pace of enrollment is rapidly accelerating with the first 75 patients taking 18 months to enroll while the second 75 patients took less than 6 months to enroll; Enrolled 25 patients in June; and Expanded study with commencement of enrollment and dosing in Italy. Pre-Planned Interim Analysis Update – Company Expects Interim Analysis by Year End: As noted above, the Company has now 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 based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma. CNS 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.