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CNS Pharmaceuticals Announces Successful Interim Analysis of Efficacy and Safety Data in Potentially Pivotal Study of Berubicin
Independent DSMB recommends continuing clinical trial of Berubicin without modificationEnrollment expected to be complete in early Q1 2024HOUSTON, TX /
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Independent DSMB recommends continuing clinical trial of Berubicin without modificationEnrollment expected to be complete in early Q1 2024HOUSTON, TX / ACCESSWIRE / December 18, 2023 / 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 the recommendation of the independent Data Safety Monitoring Board (DSMB) that the Company's ongoing global, potentially pivotal trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme (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 measures progression-free survival (PFF) and overall response rate (ORR), as well as safety data in evaluable patients. In order to support continuing the trial, Berubicin's efficacy had to be at least comparable to Lomustine's on the primary endpoint (OS).\"Having successfully reached this milestone, we believe that this recommendation reflects Berubicin's acceptable efficacy and safety profile, as defined in the trial protocol, as of the interim analysis. Building on the foundation of strong enrollment laid by our team, our investigators and their patients, the independent findings of the DSMB add to the Phase 1 trial data, where 44% of treated patients received a clinical benefit of stable disease or better,\" said John Climaco, CEO of CNS Pharma. \"Finding an effective treatment for GBM remains one of the great challenges in oncology, and more meaningful options for the many patients who fail first-line therapy are still desperately needed after decades of research. With this recommendation to continue the study, our long-held belief that Berubicin will ultimately address the unmet clinical need of GBM patients now moves closer to becoming reality.\"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 f...