CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, this morning announced that it has received US Food and Drug Administration (“FDA”) approval of its Investigational New Drug (“IND”) application on its lead product candidate Berubicin for the treatment of Glioblastoma Multiforme (“GBM”). This approval signifies a crucial step for the company in launching a potentially pivotal trial to investigate the efficacy of Berubicin in adults with GBM who have been unsuccessful with first-line therapy. In addition, following recent correspondence with the FDA, the company has modified the previously disclosed trial design, naming overall survival (“OS”) as the primary endpoint of the study. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” CNS Pharmaceuticals CEO John Climaco stated in the news release. “The company will transform within the next several months as Berubicin becomes the subject of up to three active clinical trials, which include our randomized, controlled Phase 2 trial in the U.S., and 2 trials planned by our sublicensee WPD in Poland. We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. We have a tremendous opportunity ahead of us as we continue our mission to improve patient outcomes for GBM and build on the promising results demonstrated by Berubicin in its Phase 1 clinical trial.”
To view the full press release, visit https://ibn.fm/s44FT
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.
NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP
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