Business
CNS Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Outlook
Recently granted FDA Fast Track Designation for Berubicin for treatment of recurrent Glioblastoma Multiforme (GBM) provides an accelerated pathway to
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Recently granted FDA Fast Track Designation for Berubicin for treatment of recurrent Glioblastoma Multiforme (GBM) provides an accelerated pathway to potential approval and commercialization\n Potentially pivotal study for lead program evaluating Berubicin in the treatment of adult GBM is on track\n Platform opportunities for expansion into additional oncology indications with significant unmet needs\n\n\nHOUSTON, Aug. 13, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (\"CNS\" or the \"Company\"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system (CNS), today reported its financial results for the quarter ended June 30, 2021. Additionally, the Company provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer.\n\n \n \n \n \n \n \n\n \nRecent Highlights\nCommenced patient enrollment in potentially pivotal US-based trial evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM; Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for lead investigational drug candidate, Berubicin, for the treatment of patients with recurrent GBM; and \"Over the course of the second quarter, our team continued to execute on corporate, clinical and regulatory strategies to drive our Berubicin program toward regulatory approval as fast as possible. We are guided by our passion to answer one of the most devastating unmet clinical needs in medicine: unbelievably, patients suffering today from recurrent GBM still cannot turn to a single approved treatment anywhere in the world for hope. Simply put, this must change and we are the company to change it. With the FDA's recent award of Fast Track Designation for our lead program, we believe we are poised to finally bring a desperately-needed treatment to GBM patients potentially through this accelerated pathway. Building on a foundation of sixty years of successful anthracycline use against numerous deadly cancers as well as powerful data from our Phase 1 study of Berubicin, the only anthracycline which appears to cross the blood brain barrier in adults, we wholeheartedly believe in its potential to transform the current treatment landscape and th...