CNS Pharmaceuticals (NASDAQ: CNSP) continues to aggressively pursue FDA approval for its lead drug candidate, Berubicin. The novel candidate is the first anthracycline that appears to be able to cross the blood-brain barrier to combat tumors — stepping up its cancer-fighting potential. Berubicin was the subject of a Phase 1 safety trial conducted by Reata Pharmaceuticals approximately 15 years ago. One of the trial participants has remained alive and cancer-free as of the most recent evaluation late last year, while two other patients in the small study saw reductions of greater than 25% (one being an 80% reduction) in the size of their tumors. CNS Pharmaceuticals is advancing the development of Berubicin for potential commercialization in treating glioblastoma multiforme (“GBM”), a type of brain cancer that is nearly 100% fatal in one year after diagnosis. The company has progressed its plans for a world-spanning Phase 2 trial comparing Berubicin’s response to the effectiveness of established chemotherapy drug lomustine in 243 GBM patients. “The participants for the Phase 2 study will be adult GBM patients with recurrent disease (Grade IV, as measured by the World Health Organization) after the failure of standard first-line therapy,” reads a recent article on the new trial. “The primary endpoint of the study is to demonstrate overall survival, ‘a rigorous endpoint the FDA recognizes when a statistically significant improvement can be shown relative to a randomized control arm,’ the company states.”
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About CNS Pharmaceuticals Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (“GBM”), an aggressive and incurable form of brain cancer. For more information, visit the company’s website at www.CNSPharma.com.
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