CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and CNS, provided an update on the manufacturing strategy for Berubicin drug product, its lead drug candidate for the treatment of glioma brain tumors.

In June, CNS Pharmaceuticals successfully engaged USA-based Pharmaceutics International, and Italian BSP Pharmaceuticals, respectively, for the production of Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy in order to mitigate both COVID-19 related risks, as well as to diversify its supply chain and reduce the risk that inefficiencies could impact the Company's clinical timeline. The Company's decision to have both a European and United States manufacturer also provides for localized availability of Berubicin for the upcoming phase I Pediatric and phase II adult studies in Poland and the US phase II trial. As previously announced, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and has now shipped API to two companies that will prepare an injectable form of Berubicin ready for clinical use. This is an important step to allow CNS to initiate clinical studies in GBM patients.

“Our decision to contract both Pii and BSP represents a key part of our overall strategy to get Berubicin back into clinical trials as soon as possible,” stated John Climaco, CEO of CNS Pharmaceuticals. "Importantly, we felt it prudent to diversify our production strategy given the difficulty of predicting COVID-19 related risks and supply chain constraints. With our laser focus on initiating our phase 2 trials by the end of the 2020, we believe the decision to engage both manufacturers’ positions us optimally to continue to execute on our timeline and reduce the risks of delays.”