CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, announced a recommendation from the independent Data Safety Monitoring Board (“DSMB”) regarding Berubicin, the company’s investigational agent. According to the announcement, the DSMB recommends that CNS Pharmaceuticals’ ongoing global, potentially pivotal trial of Berubicin for the treatment of glioblastoma multiforme (“GBM”) continue without modification. The company also noted that it anticipated enrollment for the trial to be complete in the first quarter of 2024.
The Berubicin study is a multicenter, open-label, randomized controlled study evaluating adult patients with recurrent GBM (WHO Grade IV) where standard first-line therapy has failed, compared to Lomustine. Berubicin is an anthracycline, which is a class of anticancer agents among the most powerful chemotherapy drugs and that are effective against more types of cancer than any other class of chemotherapeutic agents.
“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,” said CNS Pharmaceuticals CEO John Climaco in the press release. “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. 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.”
To view the full press release, visit https://ibn.fm/4IWgz
About CNS Pharmaceuticals Inc.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The company’s lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. For more information about the company, please visit www.CNSPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP
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