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CNS Pharmaceuticals Announces Dosing of First Patient in Europe/France in Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM
Enrollment progressing toward interim analysis, planned when 30-50% of subjects reach 6 months in study HOUSTON, Nov. 2, 2022 /PRNewswire/ -- CNS
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Enrollment progressing toward interim analysis, planned when 30-50% of subjects reach 6 months in study\nHOUSTON, Nov. 2, 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 the first patient in Europe has been enrolled and dosed in France in the Company's ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.\n\n \n \n \n \n \n \n\n \nThe Company has opened 29 clinical trial sites of the 68 sites selected across the U.S., Italy, France, Spain, and Switzerland. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.\n\"Our team has worked tirelessly to expand the presence of our clinical trial for Berubicin on a global scale. To have enrolled and dosed our first patient in France shortly after the opening the site is a noteworthy accomplishment and a testament to our team's dedication to drive the program forward. I am pleased with the progress made and remain committed to building on this momentum. We expect to enroll and dose additional patients across our clinical trial sites in Europe and advance toward the much-anticipated inflection point which is the interim analysis,\" commented John Climaco, CEO of CNS Pharmaceuticals.\nBerubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) 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 approval of oncology drug...