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CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM
Expanded eligibility for patients who have received multiple therapies as first line therapy for GBM Company continues to enroll patients for the trial with
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Expanded eligibility for patients who have received multiple therapies as first line therapy for GBM\nCompany continues to enroll patients for the trial with 19 clinical trial sites open to-date, and an additional 42 sites selected across the U.S., Italy, France, Spain, and Switzerland that will be initiated and enrolling soon \nInterim analysis of the trial when 30- 50% of subjects reach 6 months in study\nHOUSTON, June 23, 2022 /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 it has received approval from the U.S. Food and Drug Administration (FDA) for its ongoing potentially pivotal global study evaluating the efficacy and safety of Berubicin compared with Lomustine (Gleostine) administered after first line therapy for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.\n\n \n \n \n \n \n \n\n \n\"We are pleased to have received this positive response from the FDA and to continue driving the Berubicin clinical development program forward. The key objectives for the protocol amendment are based on the feedback we received from investigators and further consideration of the needs of patients on the study. We have also incorporated the recent WHO classification of glioblastoma1 with pertinent guidelines, ensuring that these patients meet specific criteria that allows us to accurately position the program for success. I am proud of the progress we continue to make on the clinical and regulatory fronts and look forward to further advancing this important trial,\" commented John Climaco, CEO of CNS Pharmaceuticals.\nBerubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a global potentially pivotal study evaluating its efficacy and safety.\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 (OS), which is a rigorous endpoint that the FDA has recognized as a basis for ...