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CNS Pharmaceuticals Berubicin Trial is On Schedule to Commence in March 2021
Potentially pivotal study evaluating efficacy of Berubicin in the treatment of adult Glioblastoma Multiforme (GBM), one of the most aggressive types of brain
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Potentially pivotal study evaluating efficacy of Berubicin in the treatment of adult Glioblastoma Multiforme (GBM), one of the most aggressive types of brain cancer\n\n\nHOUSTON, Feb. 25, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (\"CNS\" or the \"Company\"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today indicated that the clinical program for Berubicin is on track to start enrolling patients in March 2021. CNS' lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to cross the blood-brain barrier. It is in development for the treatment of a number of serious brain and CNS oncology indications.\n\n \n \n \n \n \n \n\n \nPreparations are proceeding on schedule for the Company's study evaluating the efficacy of Berubicin in the treatment of GBM. The Company intends to enroll subjects across approximately 35 clinical sites in the U.S., with 21 sites currently confirmed and in a start-up process. The Company also plans to expand the trial into western Europe.\n\"I am very pleased with our progress and the team's execution towards the start of our program. We have made significant advancements and are now finalizing clinical site selection and preparing to begin patient screening, which we expect to commence next month,\" commented John Climaco, CEO of CNS Pharmaceuticals. \"Berubicin's promising results demonstrated in the Phase 1 clinical trial build on sixty years of clinical experience with anthracyclines. Berubicin is an entirely novel molecule that represents an opportunity to recognize the powerful benefits of this tried-and-true class of drugs for neuro-oncology in general and in the fight against GBM in particular. We are deeply committed to driving this program forward as expeditiously as possible with the prime focus on our mission to improve patient outcomes for GBM.\"\nThe potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis f...