Business
CNS Pharmaceuticals Announces First Patient Enrolled in Spain in Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM
Enrollment continuing to progress toward an interim analysis, planned when 30-50% of subjects reach the primary endpoint expected mid-year 2023 HOUSTON, Feb.
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Enrollment continuing to progress toward an interim analysis, planned when 30-50% of subjects reach the primary endpoint expected mid-year 2023\nHOUSTON, Feb. 7, 2023 /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 first patient in Spain has been enrolled 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 37 clinical trial sites of the 59 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 reached the primary endpoint. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.\n\"We continue to rapidly build momentum with patient enrollment across our clinical trial sites in Europe. The pace at which we are enrolling patients is encouraging and driving us toward our planned interim analysis, which we expect mid-year 2023. We sincerely appreciate the institutions, clinicians and staff that are contributing to the conduct of this trial, and are extremely grateful to the patients that choose to participate. We are laser focused on executing on clinical development plans and look forward to providing updates,\" 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. This trial is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy compared to the standard of care (SOC). The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a stat...