CNS Pharmaceuticals (NASDAQ: CNSP) and WPD Pharmaceuticals (CSE: WBIO) (8SV1.F) (“WPD”), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Multiforme (“GBM”) under the WPD-201 Clinical Trial Protocol. CNS Pharmaceuticals has received study level approval from the Central IRB for the CNS-201 Clinical Trial Protocol. Berubicin is the company’s novel anthracycline candidate for the treatment of a number of serious oncology indications, currently in development for the treatment of GBM. CNS entered into a sublicense agreement with WPD in November 2019, which provided WPD the commercial rights to Berubicin in select territories in Europe and Asia. “We are pleased for WPD to achieve this key milestone and are encouraged by their continued execution in furthering the development of Berubicin,” said John Climaco, CEO of CNS Pharmaceuticals. “Importantly, we believe WPD’s Ethics Committee approval of the WPD-201 Clinical Trial Protocol coupled with our recent IND approval and Central IRB Study Level approval, position us one step closer to collaboratively initiating three clinical trials for Berubicin during 2021. We look forward to continuing our trial preparations, as well as WPD’s planned submissions to the Polish Competent Authority.”
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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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