NetworkNewsBreaks – CNS Pharmaceuticals Inc. (NA
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CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, has begun open enrollment for its upcoming study focused on analyzing the efficacy and safety of Berubicin in the treatment of adult recurrent Glioblastoma Multiforme (“GBM”). GMB is one of the most aggressive types of brain cancer, and Berubicin, which is in development for the treatment of several serious brain and CNS oncology indications, is the first anthracycline to cross the blood-brain barrier. CNSP plans on enrolling some 210 subjects across 35 clinical sites in the United States; the company also intends to expand the trial into Western Europe. The potentially pivotal trial is designed as an adaptive, multicenter, open-label, randomized and controlled study in adult patients diagnosed with GBM (WHO Grade IV) after failure of standard first-line therapy. The company noted that the primary endpoint of the study is overall survival, a rigorous endpoint that the U.S. Food and Drug Administration has established as a basis for approval of oncology drugs. “We are delighted to begin patient enrollment and screening in this potentially pivotal trial that will provide greater insight into the potential of Berubicin to improve patient outcomes in the treatment of GBM,” said CNS Pharmaceuticals CEO John Climaco in the press release. “This represents an important milestone for our pivotal program. I would like to thank our clinical team for their commitment and drive to advance this important development program.”
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