CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, has begun open enrollment for its upcoming study focused on analyzing the efficacy and safety of Berubicin in the treatment of adult recurrent Glioblastoma Multiforme (“GBM”). GMB is one of the most aggressive types of brain cancer, and Berubicin, which is in development for the treatment of several serious brain and CNS oncology indications, is the first anthracycline to cross the blood-brain barrier. CNSP plans on enrolling some 210 subjects across 35 clinical sites in the United States; the company also intends to expand the trial into Western Europe. The potentially pivotal trial is designed as an adaptive, multicenter, open-label, randomized and controlled study in adult patients diagnosed with GBM (WHO Grade IV) after failure of standard first-line therapy. The company noted that the primary endpoint of the study is overall survival, a rigorous endpoint that the U.S. Food and Drug Administration has established as a basis for approval of oncology drugs. “We are delighted to begin patient enrollment and screening in this potentially pivotal trial that will provide greater insight into the potential of Berubicin to improve patient outcomes in the treatment of GBM,” said CNS Pharmaceuticals CEO John Climaco in the press release. “This represents an important milestone for our pivotal program. I would like to thank our clinical team for their commitment and drive to advance this important development program.”
To view the full press release, visit https://ibn.fm/KVA0O
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. During 2021, CNS expects to commence a phase 2 clinical trial of Berubicin for the treatment of GBM in the United States, while a sublicensee partner undertakes a phase 2 trial, with extensive PK (“PK”) in adults and a first-ever phase 1 trial in pediatric GBM patients in Poland. CNS Pharmaceuticals’ 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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