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 through its European manufacturer, BSP Pharmaceuticals S.p.A. (“BSP”), finished manufacturing its lead drug candidate for upcoming Phase 2 clinical trials. Berubicin is CNSP’s lead drug candidate for the treatment of glioblastoma multiforme (“GBM”), an aggressive form of brain cancer that is incurable. With the completion of the manufacturing, CNS Pharmaceuticals is now ready to kick off its planned Phase 2 clinical trials and file an Investigational New Drug Application (“IND”). CNSP contracted with two manufacturers on two continents — BSP Pharmaceuticals S.p.A. and Pharmaceutics International Inc. (“Pii”) — to alleviate any potential risks. The decision also allowed the company to expand its supply chain and prepare for more convenient availability of Berubicin. Both BSP and Pii have completed manufacturing the drug. “We are pleased to continue to execute upon our dual-track drug product manufacturing strategy, as both our U.S. manufacturer, Pii, and European manufacturer, BSP, have now completed production of Berubicin Drug Product,” said CNS Pharmaceuticals CEO John Climaco in the press release. “The completion of the manufacturing process at both locations represents a key milestone for us and will further support our efforts to file an IND during the fourth quarter of this year. We are encouraged by our continued execution upon our pre-trial initiatives, and believe we remain positioned to initiate a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.”
To view the full press release, visit https://ibn.fm/zOW5P
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 United States, 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. The company’s 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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