The subjects will be randomized in a 2:1 ratio to receive Berubicin or lomustine, a compound used in chemotherapy, to evaluate overall survival, the study’s primary endpoint. The study is expected to potentially build on the phase 1 trial and pharmacokinetic study of Berubicin, whose results revealed that 44% of the patients showed clinical response of stable disease or better, with one patient demonstrating a lack of detectable cancer cells and two patients with partial tumor reduction of up to 80%.

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.

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