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 received approval from the Switzerland Ethics Committee (swissethics) — the first approval of its kind from a European ethics committee — for its study of Berubicin. Exclusive to CNS Pharmaceuticals, Berubicin is the first anthracycline that appears to cross the blood-brain barrier; the substance is being assessed in a global study designed to evaluate efficacy and safety in the treatment of recurrent glioblastoma multiforme (“GBM”). The adaptive, multicenter, open-label, randomized and controlled study is set to begin soon and will have study sites across Europe and in the United States. “Receiving approval from swissethics is a significant milestone for the company,” said CNS Pharmaceuticals CEO John Climaco in the press release. “Our stated goal is, and always has been, to see Berubicin approved for the treatment of glioblastoma, and this means globally. This terrible disease does not discriminate on the basis of geography or anything else: patients in Europe are as desperate as patients in the United States , and treating patients is not only why we do what we do, but how we do it as well. Driving patient enrollment is how we advance Berubicin’s development and opening additional clinical sites around the globe is the pivotal piece that allows us to ramp up our efforts and move toward data. We are deeply grateful that Switzerland has the first European EC to approve our Berubicin trial, but we are confident it will be far from the last in this truly global effort. We have a number of additional clinical sites selected around the world that we anticipate coming online in the very near term. As we progress, my belief grows in the enormous potential of Berubicin to be a critical treatment option for this devastating disease. I am proud of the accomplishments we’ve made with this potentially pivotal trial to-date, but we will not pause for a single second until Berubicin reaches its full potential to offer hope to GBM patients everywhere.”
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About CNS Pharmaceuticals Inc.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The company’s lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme, an aggressive and incurable form of brain cancer. Additionally, CNS Pharmaceuticals is advancing the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small-molecule agents and is believed to be 500 times more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain, pancreatic and ovarian cancers as well as lymphomas. For more information about the company, please visit www.CNSPharma.com
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