Business
CNS Pharmaceuticals Receives Approval from Competent Authority and Central Ethics Committee in Italy for Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM
Continued advancement of global patient enrollment with approvals and site activations in the U.S., Switzerland, France, Spain and ItalyEnrollment continuing
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Continued advancement of global patient enrollment with approvals and site activations in the U.S., Switzerland, France, Spain and ItalyEnrollment continuing to progress toward an interim analysis expected in the third quarter of 2023HOUSTON, TX / ACCESSWIRE / April 6, 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 it has received approval from the Italian Medicines Agency (\"AIFA\") Competent Authority and the A.O.U. Policlinico di Bari Ethics Committee for its ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.The Company plans to open its clinical sites in Italy imminently in addition to the previously opened 41 clinical trial sites of the 60 sites selected across the U.S., France, Spain, and Switzerland. 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 with Lomustine. The Company will conduct this analysis after at least 50% of the patients in the population to be analyzed for the interim analysis (30-50% of the total number of patients for this trial) can be evaluated as having failed the primary efficacy endpoint (death). The DSMB will review the number of deaths on each arm to ensure that the overall survival of patients receiving Berubicin shows at least a statistically significant comparability to those receiving Lomustine. Additional analyses that will be provided based on this data will be comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments. Enrollment will not be paused during this interim analysis.\"Our team has continued to make dedicated efforts to build momentum and drive patient enrollment in this important clinical trial. We are incredibly pleased to add Italy to our growing portfolio of European countries for this global study. Our team continues to focus on bringing additional clinical trial sites online...