CNS Achieves Key Milestones in Berubicin Dual-track Mfg. Strategy

CNS Pharmaceuticals, Inc. has achieved a key milestone for the U.S. manufacture of Berubicin, the company's lead drug candidate for the treatment of malignant gliomas, in preparation for upcoming clinical trials.

CNS previously implemented a dual-track drug product manufacturing strategy and contracted U.S.-based Pharmaceutics International, Inc. (Pii) and Italy-based BSP Pharmaceuticals 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.

CNS has completed synthesis of Berubicin 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. CNS and Pii completed a successful lab simulation of the lyophilization cycle and manufacturing of Berubicin at Pii is expected during 3Q20.

CNS also recently engaged Worldwide Clinical Trials as the contract research organization (CRO) for its upcoming Berubicin trials.

Berubicin was recently granted Orphan Drug Designation (ODD) for the treatment of malignant gliomas. The designation provides Berubicin with a special status that can help accelerate its development with the potential for market exclusivity upon approval. CNS plans to file an IND with the FDA during 4Q20.