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 GMP manufacturer partner NCK A/S, received a Certificate of Analysis (“CoA”) for its Active Pharma Ingredient (“API”), clearing it for use in the production of Berubicin. CNS Pharmaceuticals previously announced entry into a contract with NCK A/S, a GMP manufacturer of complex drugs and the previous producer of Berubicin for Reata Pharmaceuticals, for the large-scale production of Berubicin, CNSP’s lead drug candidate for the treatment of glioma brain tumors. “We believe the execution of this critical manufacturing milestone positions the company advantageously ahead of our expected U.S. Phase 2 trial,” said John Climaco, CEO of CNS Pharmaceuticals, in the news release. “Our partnerships have proven instrumental in further progressing the manufacturing process necessary to continue the clinical development of our lead candidate. We look forward to continuing the work underway and to initiating our U.S. Phase 2 trial in Q1 of 2021.”
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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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