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 completed enrollment in its global potentially pivotal study evaluating Berubicin. According to the announcement, the study has enrolled 247 patients across 46 clinical trial sites in the United States, Italy, France, Spain and Switzerland. A novel anthracycline, Berubicin appears to be the first anthracycline to cross the blood-brain barrier for the treatment of glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. The Berubicin study is a multicenter, open-label, randomized controlled study of adult patients with recurrent GBM after failure of standard first-line therapy and compared to Lomustine. The company has received approval from the U.S. Food and Drug Administration for Fast Track Designation for Berubicin; this means the company can interact more frequently with the agency for guidance on expediting the development and review process. CNSP has also received Orphan Drug Designation from the FDA for using Berubicin to treat malignant glioma. “The completion of planned enrollment is yet another important milestone for the company,” said CNS Pharmaceuticals CEO John Climaco in the press release. “With the DSMB’s recent positive recommendation based on the interim analysis and the completion of planned enrollment, we are now focused on bringing this study across the finish line. We remain hopeful in our effort to address this devastating disease and potentially offering an effective treatment in GBM that is safe and well tolerated.”
To view the full press release, visit https://ibn.fm/QZrTE
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 (“GBM”), an aggressive and incurable form of brain cancer. For more information about the company, please visit www.CNSPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP
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