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, have entered into an agreement for WPD to obtain Investigational Medicinal Product (“IMP”) classification for Berubicin for its use in upcoming clinical trials. According to the update, WPD will purchase half of the batch previously manufactured for CNS by BSP Pharmaceuticals for the WPD-201 and WPD-201P studies, planned to begin in the first half of 2021. Berubicin is a novel anthracycline candidate for the treatment of a number of serious oncology indications including Glioblastoma Multiforme (“GBM”). WPD sublicensed Berubicin from CNS in November 2019, providing WPD with commercial rights to Berubicin in select territories primarily in eastern Europe and Asia. “This agreement will allow us to submit a complete application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA, to initiate the studies without any delay,” said Mariusz Olejniczak, CEO of WPD.
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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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