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, today announced that its European manufacturer, BSP Pharmaceuticals S.p.A. (“BSP”), has begun the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (“GBM”). GBM is an aggressive form of brain cancer currently considered incurable. “Our preparations for filing an IND for Berubicin require continued execution in both our clinical and manufacturing initiatives,” CNS Pharmaceuticals CEO John Climaco said in the news release. “With the manufacturing of our Berubicin Drug Product in Europe, we continue to advance closer toward an IND filing for Berubicin, which we expect to submit later this quarter. We have also made significant progress on the clinical front and recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group (‘IAG’) as the imaging partner, and Berry Consultants as a biostatistical advisor for our Phase 2 trial design. We have also added Dr. Patrick Wen, a renowned neuro-oncologist, to our Scientific Advisory Board. Our laser focus remains on initiating a U.S. Phase 2 trial for Berubicin in Q1 of 2021 and we continue to demonstrate our ability to execute our operational and clinical plans toward that goal.”
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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 U.S., 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. Its 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, visit the company’s website at www.CNSPharma.com.
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