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 completed the manufacturing process for Berubicin Drug Product. CNSP’s U.S. manufacturer, Pharmaceutics International Inc. (“Pii”), has finished manufacturing the drug, which is the company’s lead drug candidate for the treatment of glioblastoma multiforme (“GBM”), an aggressive form of incurable brain cancer. In an attempt to diversify its supply chain, provide for local accessibility of Berubicin and reduce COVID-19-related delay risks, CNS had implemented a dual-track drug product manufacturing approach that used two different manufacturers for the drug; the two companies are located in different countries. CNSP contracted with Pii to make the drug in the United States and is working with BSP Pharmaceuticals S.p.A. (“BSP”) in Italy as well. BSP is on schedule to complete manufacturing later this year. CNS has also partnered with three separate companies as it prepares for its upcoming clinical trial of Berubicin. Worldwide Clinical Trials is the project’s contract research organization, Image Analysis Group (“IAG”) is the imaging partner and Berry Consultants will be the biostatistical advisor for the Phase 2 trial design. “Completing the manufacturing process for Berubicin in the United States is an essential step in our preparations to file an IND during the fourth quarter of this year,” CNS Pharmaceuticals CEO John Climaco stated in the press release. “We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021.”
To view the full press release, visit https://ibn.fm/qfy7A
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. 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, 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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