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CNS Pharmaceuticals (NASDAQ:CNSP) Achieves Over 50% Completion of Enrollment in Potentially Pivotal Study with Berubicin for the Treatment of Glioblastoma Multiforme (GBM)
Company continues to execute on rapid progression of enrollment toward planned interim analysis expected in the third quarter of 202345 clinical trial sites
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Company continues to execute on rapid progression of enrollment toward planned interim analysis expected in the third quarter of 202345 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland open and enrolling patientsHOUSTON, TX / ACCESSWIRE / May 25, 2023 / 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 its ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer, has enrolled 134 patients, representing more than 50% of the total planned enrollment for the study.\"The achievement of this milestone in any study is no small feat. The dedication of our team and the proficiency of their operational execution continues to be shown by reaching over 50% of the total planned enrollment in our study. This is an important step that brings us closer to providing a potential treatment option to patients with GBM and addressing this disease, which remains a significant unmet need. We are focused on continuing this momentum towards the interim analysis for the study, which remains on target for the third quarter of this year,\" commented John Climaco, CEO of CNS Pharmaceuticals.This potentially pivotal global study 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 lomustine as 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 statistically significant improvement can be shown relative to a randomized control arm.A pre-planned, non-binding futility analysis will be conducted by an independent Data Safety Monitoring Board (DSMB) to recommend whether this study should continue as planned based on Berubicin showing value as a second-line treatment for patients with glioblastoma compared to Lomustine. The Company will conduct this analysis after at least 50% of the patients in the population to be analyzed for the int...