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, announced that the U.S. Food and Drug Administration granted Fast Track Designation for Berubicin, the company’s lead investigational drug. The status was received for the company’s evaluation of Berubicin for the treatment of patients with recurrent glioblastoma multiforme (“GBM”). An anthracycline, Berubicin falls in a class of anticancer agents that are among the most powerful chemotherapy drugs, proven to be effective against more types of cancer than any other category of chemotherapeutic agents. Fast Track Designation provides opportunities to expedite the development and review process for drugs intended to treat serious or life-threatening conditions when those drugs show potential to address unmet medical need. CNS has already begun patient enrollment in its upcoming study of Berubicin for the treatment of recurrent glioblastoma multiforme. “Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain,” said CNS Pharmaceuticals CEO John Climaco in the press release. “If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options, and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease.”
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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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