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, is advancing a drug candidate it hopes will beat the deadly brain cancer Glioblastoma Multiforme (“GBM”). The company recently announced that its submission of an Investigational New Drug (“IND”) application to the U.S. Food & Drug Administration (“FDA”) has been accepted for review and discussed a novel clinical design for its upcoming Phase 2 U.S. trial in a webinar open to the public. “I would like to remind everyone that this upcoming Phase 2 trial will build on the success of the Phase 1 trial of Berubicin in which the clinical benefit response was 44%, including one patient … who had a durable complete response and is still alive and cancer-free today, 14 years after treatment with Berubicin, and another two patients with partial responses, who had reductions of greater than 25% in the size of their tumors,” CNS Pharmaceuticals CEO John Climaco told the webinar audience.
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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. 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 to be 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, visit the company’s website at www.CNSPharma.com.
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