CNS Pharmaceuticals announced the Company's U.S. manufacturer, Pharmaceutics International, Inc. (Pii), 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.
"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," said John Climaco, CEO of CNS Pharmaceuticals. "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."
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The Company implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Under this strategy, it engaged two separate manufacturers for Berubicin on different continents. In the United States, the Company engaged Pii, who has now completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A. (BSP). BSP has begun the manufacturing process, which is expected to be completed early in the fourth quarter this year.