CNS Pharmaceuticals presents update from ongoing study of berubicin

CNS Pharmaceuticals (CNSP) announced the presentation of updated results from the on-going potentially pivotal study evaluating Berubicin, the Company’s novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a randomized, controlled study vs. Lomustine, which has been considered to be a standard of care in this recurrent glioblastoma population. This was a poster presentation at the 29th Annual Meeting of the Society for Neuro-Oncology held November 21-24, 2024 in Houston, TX. The poster titled, “Update on a Potentially Pivotal Trial CNS-201: A Randomized, Controlled Trial of Berubicin Vs. Lomustine After First-Line Therapy for Glioblastoma Multiforme,” was presented bySandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals. The data presented at the SNO Annual Meeting include comparative demographics, disposition of patients, MGMT promoter methylation status and safety, showing that the balance between the randomized arms has been maintained through enrollment of 239 patients into the study. Summary of Updated Results from the Potentially Pivotal Study: All patients enrolled show comparable demographics within each arm, including age, gender, race, BSA, and KPS. In addition, patients with unmethylated MGMT comprise approximately 40% in both arms, allowing for a reasonable comparison of efficacy irrespective of the methylation status. There is a slightly greater percentage of patients on the Berubicin arm compared to the Lomustine arm that have completed the study, but a greater percentage of patients on the Lomustine arm have withdrawn from the study, the most common reasons being patient preference and death. All grades of any reported adverse events and those of Grade 3-5 in severity occurring in more than 10% of patients are shown to be relatively similar in the Berubicin and Lomustine arms. A slightly greater percentage of patients with all grades or Grades 3-5 with anaemia, headache, and decrease in neutrophil counts were shown in patients receiving Berubicin, while a significantly greater percentage of patients with a decrease in platelet counts and thrombocytopenia occurred in patients receiving Lomustine. 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 in April 2024, the Company completed enrollment with 252 patients in this study evaluating Berubicin vs. Lomustine for the treatment of GBM. In December 2023, the Company announced the successful completion of its pre-planned interim futility analysis of efficacy and safety and received a recommendation from the independent Data Safety Monitoring Board to continue the study without modification. CNS Pharmaceuticals expects to report primary analysis data from its potentially pivotal study of Berubicin in the first half of 2025.