CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, has scheduled a webcast today during which it will be discussing its plan to submit a phase 2 clinical trial design for FDA review. The call, which will be moderated by Robert LeBoyer, managing director of Equity Research at Ladenburg Thalmann & Co. Inc., will start at 4:30 p.m. ET. The phase 2 trial design is for the U.S. trial for CNSP’s Berubicin. Berubicin is the company’s lead drug candidate for the treatment of glioblastoma multiforme (“GBM”). The phase 2 trial is comprised of randomized patients who will receive either Berubicin or standard of care. Interim assessments will be conducted to evaluate the comparative safety and effectiveness of these treatments. CNS Pharmaceuticals anticipates submitting an Investigational New Drug (“IND”) application to the U.S. Food & Drug Administration (“FDA”). That application will include a novel clinical trial designed to build on the results reported from the drug’s phase 1 clinical trial.
To view the webcast, visit https://nnw.fm/FR7OC
To view the full press release, visit https://nnw.fm/pGXXU
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. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the United States, while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. The company’s second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information about the company, please visit www.CNSPharma.com
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