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CNS Pharmaceuticals Announces FDA Filing of IND for its Brain Cancer Drug Berubicin
Expects to initiate Phase 2 trial during the first quarter of 2021 HOUSTON, Nov. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Expects to initiate Phase 2 trial during the first quarter of 2021\n\n\nHOUSTON, Nov. 17, 2020 /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 announced that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of Glioblastoma Multiforme (GBM). The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA's acceptance of the Company's filing.\n\n \n \n \n \n \n \n\n \n\"Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible,\" commented John Climaco, CEO of CNS Pharmaceuticals. \"Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM.\"\nThe planned Phase 2 trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease, and results will be compared to the current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin or Lomustine. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments. The trial's adaptive design is intended to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to pr...