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 confirmed that the clinical program for Berubicin is on track to start enrolling patients in March 2021. CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to cross the blood-brain barrier and is in development for the treatment of a number of serious brain and CNS oncology indications. The upcoming, potentially pivotal study will evaluate the efficacy of Berubicin in the treatment of adult glioblastoma multiforme (“GBM”), one of the most aggressive types of brain cancer. “I am very pleased with our progress and the team’s execution towards the start of our program. We have made significant advancements and are now finalizing clinical site selection and preparing to begin patient screening, which we expect to commence next month,” said John Climaco, CEO of CNS Pharmaceuticals. “Berubicin’s promising results demonstrated in the Phase 1 clinical trial build on sixty years of clinical experience with anthracyclines. Berubicin is an entirely novel molecule that represents an opportunity to recognize the powerful benefits of this tried-and-true class of drugs for neuro-oncology in general and in the fight against GBM in particular. We are deeply committed to driving this program forward as expeditiously as possible with the prime focus on our mission to improve patient outcomes for GBM.”
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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 the overall response rate of stable disease or better was 44%. 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 Feb. 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 the first quarter of 2021, 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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