CNS Pharmaceuticals presents updated safety data from berubicin study

CNS Pharmaceuticals announced the presentation of updated safety data from the ongoing potentially pivotal study evaluating Berubicin, the Company’s novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a poster presentation at the SNO 28th Annual Meeting, held November 15-19, 2023 in Vancouver, Canada. Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals presented the poster, which was titled, “A randomized, controlled trial of Berubicin vs. Lomustine after first-line therapy for glioblastoma multiforme: Interim Results.” The poster is now available on the Company’s website. The data presented at the SNO Annual Meeting show the comparability of the patient demographics in the two arms of the study, and of the safety data for each therapeutic modality in treating recurrent GBM. Patient demographics are comparable between each arm, including age, gender, race, body surface area, and Karnofsky Performance Status Scale. In addition, patients with unmethylated MGMT comprise approximately 40% of each arm, allowing for comparison irrespective of the molecular profile that might influence the efficacy of the therapy administered. Although more patients withdrew from the study in the Lomustine arm than the Berubicin arm, there are too few patients to reach any conclusion about whether this will affect the outcome. All reported adverse events for both arms are shown for all grades and grades 3-5. These were similar, including the more severe events in the higher grades. The adverse events occurring in more than 10% of patients and/or that were considered treatment-related, are shown for all grades as well as grades 3-5, and overall were relatively similar in the Berubicin and Lomustine arms. In terms of myelosuppression, there is no significant difference between the therapeutic arms, although thrombocytopenia appears to be slightly greater with Lomustine for all grades of severity as well as grades 3-5. The primary endpoint of the study is Overall Survival, a rigorous endpoint 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. 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 or not to recommend continuing the study. 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. The Company expects to release the conclusion of the DSMB before year end.