HOUSTON - CNS Pharmaceuticals, Inc. (NASDAQ:CNSP), a biopharmaceutical company focused on developing treatments for brain and central nervous system cancers, has announced the completion of enrollment in a global study of Berubicin for glioblastoma multiforme (GBM), an aggressive type of brain cancer.
The study is an open-label, randomized controlled trial that has enrolled 247 patients at 46 clinical sites across the United States, Italy, France, Spain, and Switzerland. It compares Berubicin, CNS's investigational anthracycline, to Lomustine, a standard therapy for patients with recurrent GBM after initial treatment failure. The primary goal of the trial is to measure overall survival (OS), a key factor the FDA considers for oncology drug approvals.
John Climaco, CEO of CNS Pharmaceuticals, expressed optimism about the study's progress, particularly after a positive recommendation from the independent Data Safety Monitoring Board (DSMB) based on an interim analysis conducted on December 18, 2023. The DSMB advised continuation of the trial without modifications after reviewing unblinded data on overall survival and secondary measures including progression-free survival and overall response rate.
Berubicin is the first anthracycline believed to cross the blood-brain barrier, a significant challenge in treating brain cancers. The FDA has granted the drug Fast Track Designation, which could expedite the development and review process, and Orphan Drug Designation, potentially providing seven years of marketing exclusivity upon approval.
The drug was developed by Dr. Waldemar Priebe at The University of Texas MD Anderson Cancer Center and has shown promise in a Phase 1 clinical trial conducted by Reata Pharmaceuticals (NASDAQ:RETA), Inc., including one durable complete response.
This news is based on a press release statement from CNS Pharmaceuticals, Inc.
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