BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Secures FDA Approval for Protocol Amendment to Ongoing Potentially Pivotal Berubicin Trial
Jun 23, 2022
CNS Pharmaceuticals (NASDAQ: CNSP) is a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system. The company today announced its receipt of approval from the U.S. Food and Drug Administration (“FDA”) for its ongoing potentially pivotal global study evaluating the efficacy and safety of Berubicin compared with Lomustine (Gleostine) administered after first line therapy for the treatment of recurrent glioblastoma multiforme (“GBM”), one of the most aggressive types of brain cancer. “We are pleased to have received this positive response from the FDA and to continue driving the Berubicin clinical development program forward,” said John Climaco, CEO of CNS Pharmaceuticals. “The key objectives for the protocol amendment are based on the feedback we received from investigators and further consideration of the needs of patients on the study. We have also incorporated the recent WHO classification of glioblastoma* with pertinent guidelines, ensuring that these patients meet specific criteria that allows us to accurately position the program for success. I am proud of the progress we continue to make on the clinical and regulatory fronts and look forward to further advancing this important trial.”
To view the full press release, visit https://ibn.fm/uG0KS
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. Additionally, the company is advancing the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x 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 cancers, pancreatic, ovarian, and lymphomas. For more information, visit the company’s website at www.CNSPharma.com.
*WHO Classification of Tumours Editorial Board. World Health Organization Classification of Tumours of the Central Nervous System. 5th ed. Lyon: International Agency for Research on Cancer; 2021
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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