CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, has provided updated information on the manufacturing of its lead drug candidate, Berubicin. The company announced it has reached key milestones in the manufacturing process as it has followed a dual-track, drug-product manufacturing strategy; CNS is working with both U.S.-based Pharmaceutics International Inc. (“Pii”) and Italy-based BSP Pharmaceuticals S.p.A. (“BSP”) in producing Berubicin. “As we prepare to initiate our upcoming Berubicin clinical trials, our execution both on the clinical and manufacturing fronts remain paramount to our success,” stated CNS Pharmaceuticals CEO John Climaco in the press release. “We continue to be encouraged as our partner Pii has now delivered upon many of the critical steps necessary to ensure the quality and availability of Berubicin. We look forward to keeping you updated on our progress as we continue our preparations to submit an IND for Berubicin during the fourth quarter of this year.”
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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 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 2020, 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 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 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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