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CNS Pharmaceuticals begins manufacturing Berubicin in Europe (NASDAQ:CNSP)

CNS Pharmaceuticals begins manufacturing Berubicin in Europe (NASDAQ:CNSP)

CNS Pharmaceuticals’ (NASDAQ:CNSP) European manufacturer, BSP Pharmaceuticals has begun the manufacturing process for Berubicin drug product.

The drug is a lead candidate for the treatment of glioblastoma multiforme or GBM, an aggressive form of brain cancer currently considered incurable.

The company’s focus remains on initiating a U.S. Phase 2 trial for Berubicin in Q1 of 2021.

“With the manufacturing of our Berubicin Drug Product in Europe, we continue to advance closer toward an IND filing for Berubicin, which we expect to submit later this quarter.” says John Climaco, CEO.

Press Release

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CNS Pharmaceuticals Begins Manufacturing of Berubicin in Europe

CNS Pharmaceuticals Begins Manufacturing of Berubicin in Europe

HOUSTON, Oct. 9, 2020 /PRNewswire/ — 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 brain and central nervous system, today announced that the Company’s European manufacturer, BSP Pharmaceuticals S.p.A. (“BSP”), has begun 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.

(PRNewsfoto/CNS Pharmaceuticals, Inc.)

“Our preparations for filing an IND for Berubicin require continued execution in both our clinical and manufacturing initiatives,” stated John Climaco, CEO of CNS Pharmaceuticals. “With the manufacturing of our Berubicin Drug Product in Europe, we continue to advance closer toward an IND filing for Berubicin, which we expect to submit later this quarter.  We have also made significant progress on the clinical front and recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group (“IAG”) as the imaging partner, and Berry Consultants as a biostatistical advisor for our Phase 2 trial design. We have also added Dr. Patrick Wen, a renowned neuro-oncologist, to our Scientific Advisory Board. Our laser focus remains on initiating a U.S. Phase 2 trial for Berubicin in Q1 of 2021 and we continue to demonstrate our ability to execute our operational and clinical plans toward that goal.”

As part of the Company’s plan to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin, the Company implemented a dual-track drug product manufacturing strategy. Under this dual-track strategy, it engaged two separate manufacturers for Berubicin on different continents, both U.S.-based Pharmaceutics International, Inc. (“Pii”) and Italy-based BSP. As previously announced, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both Pii and

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