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FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme
- FDA Fast Track Designation for Berubicin highlights the serious unmet medical need for new treatments for glioblastoma multiforme (GBM) - Company recently
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"- FDA Fast Track Designation for Berubicin highlights the serious unmet medical need for new treatments for glioblastoma multiforme (GBM)\n - Company recently commenced enrollment in potentially pivotal study evaluating Berubicin in the treatment of adult recurrent glioblastoma multiforme\n\n\nHOUSTON, June 29, 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 in the brain and central nervous system, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM. \n\n \n \n \n \n \n \n\n \n\"Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease,\" commented John Climaco, CEO of CNS Pharmaceuticals.\nFast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.\nCNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme. For more information about this study, please visit ClinicalTrials.gov and reference Identifier NCT04762069.\nAbout Berubicin\nBerubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of ...