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CNS Pharmaceuticals Provides Clinical Trial Update for Ongoing Potentially Pivotal Study with Berubicin for the Treatment of Glioblastoma Multiforme (GBM)
Company continued to see rapid progression and acceleration of enrollment with 180 patients enrolled to date across 46 clinical trial sites,
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Company continued to see rapid progression and acceleration of enrollment with 180 patients enrolled to date across 46 clinical trial sites, globallyCompletion of enrollment of study expected by end of 2023Company has documented the necessary number of patients reaching the primary efficacy endpoint (overall survival) to conduct pre-planned interim analysisTopline data from interim analysis expected before year endHOUSTON, TX / ACCESSWIRE / August 3, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) (\"CNS\" or the \"Company\"), a biopharmaceutical company specializing in the development of novel treatments for primary metastatic cancers in the brain and central nervous system, today provided a clinical update for its ongoing clinical study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer.This potentially pivotal, global study of Berubicin is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and 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.Enrollment Update - Full Enrollment of the Potentially Pivotal Study Expected by Year EndThe Company has opened 46 clinical trial sites of the approximately 60 sites selected across the U.S., Italy, France, Spain, and Switzerland. The Company is announcing today that the first clinical trial site in Italy has been activated and the enrollment and dosing of the first patient in Italy has taken place.To date, 180 patients of the expected 243 patients have been enrolled in the study.Recent Enrollment HighlightsReached 74% enrollment in study;Pace of enrollment is rapidly accelerating with the first 75 patients taking 18 months to enroll while the second 75 patients took less than 6 months to enroll;Enrolled 25 patients in June; andExpanded study with commencement of enrollment and dosing in Italy.\"Enrolling patients in an orphan disease trial is always a challenge, and that's why we are thrilled with the rate of enrollment in this potentially pivotal study. The robust interest and ...