CNS Pharmaceuticals announced its European manufacturer, BSP Pharmaceuticals S.p.A. (BSP), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. With the completion of manufacturing at BSP and at its U.S. manufacturer, Pharmaceutics International, Inc. (Pii), the Company remains poised to file an Investigational New Drug Application (IND) and initiate its Phase 2 U.S. clinical trial for Berubicin on its anticipated timeline.
"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 John Climaco, CEO of CNS Pharmaceuticals. "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."
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As a part of its strategy, the Company engaged a U.S. based manufacturer, Pii, and European manufacturer BSP, for the production of Berubicin Drug Product. The Company engaged two separate manufacturers in two separate continents in order to help mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Both Pii and BSP have now completed the manufacturing process for Berubicin.