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CNS Pharmaceuticals Achieves Completion of Planned Enrollment in Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM)
HOUSTON, TX / ACCESSWIRE / January 17, 2024 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"HOUSTON, TX / ACCESSWIRE / January 17, 2024 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) (\"CNS\" or the \"Company\"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced completion of planned enrollment in its global potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, for the treatment of GBM, an aggressive and incurable form of brain cancer.The potentially pivotal study of Berubicin is a multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and compared to Lomustine. The study has enrolled 247 patients across 46 clinical trial sites in the U.S., Italy, France, Spain, and Switzerland. The primary endpoint of the study is Overall Survival (OS), 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.John Climaco, CEO of CNS Pharmaceuticals commented, \"The completion of planned enrollment is yet another important milestone for the Company. With the DSMB's recent positive recommendation based on the interim analysis and the completion of planned enrollment, we are now focused on bringing this study across the finish line. We remain hopeful in our effort to address this devastating disease and potentially offering an effective treatment in GBM that is safe and well tolerated.\"As announced on December 18, 2023, the interim analysis of efficacy and safety data in the potentially pivotal study of Berubicin was successfully completed. The recommendation of the independent Data Safety Monitoring Board (DSMB) was that the Company's ongoing global, potentially pivotal trial of the investigational agent Berubicin for the treatment of GBM continue without any modification. The recommendation follows the DSMB's pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company's trial of Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint of overall survival (OS) and secondary efficacy m...