CNS Pharmaceuticals (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, recently 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).
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