On September 3, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, reported an update on progress for the U.S. manufacturing of Berubicin, the Company’s lead drug candidate, in preparation for upcoming clinical trials (Press release, CNS Pharmaceuticals, SEP 3, 2020, View Source [SID1234564441]).
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As previously announced, the Company implemented a dual-track drug product manufacturing strategy and engaged U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin. By engaging two separate manufacturers on two separate continents, CNS expects to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin.
Under this dual-track strategy, the Company has achieved several key milestones in its manufacturing efforts and is providing an update on the progress made with its U.S. manufacturer, Pii. First, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use. In preparation for production, CNS and Pii have now agreed on the manufacturing procedure and packaging components for Berubicin and selected a sterile filter manufacturer. The Company has also completed and reviewed a draft of the batch record. Importantly, the Company and Pii completed a successful laboratory simulation of the lyophilization cycle. The Company expects to begin manufacturing of Berubicin at Pii during the third quarter of this year.
"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 John Climaco, CEO of CNS Pharmaceuticals. "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."
CNS’s preparations for filing an IND entail both extensive clinical and manufacturing initiatives. In addition to the progress the Company has made in its manufacturing efforts, it has recently announced critical achievements made on the clinical front. The Company engaged Worldwide Clinical Trials ("Worldwide") as the contract research organization (CRO) for its upcoming Berubicin clinical trials. Worldwide specializes in therapeutic areas with unmet medical needs, including CNS disorders and oncology. Worldwide will work closely with CNS to provide proactive insight and operational support for its upcoming trials. Additionally, the Company engaged Berry Consultants, a leading clinical statistical consulting group, to advise on its Phase 2 trial design for Berubicin. Berry Consultants uses Bayesian statistics to provide innovative clinical trial designs and analysis. The Company has also completed the Phase 1 Clinical Study Report, or CSR, which is now ready for publication.
CNS was recently granted Orphan Drug Designation (ODD) for its lead product, Berubicin, for the treatment of malignant gliomas. The designation provides Berubicin with a special status that can help accelerate its development to treat malignant gliomas by providing CNS with the potential for market exclusivity upon the drug’s approval. The Company plans to file an IND for Berubicin with the FDA during the fourth quarter of 2020.