CNS Pharmaceuticals Begins Manufacturing of Berubicin in Europe

CNS Pharmaceuticals 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.

John Climaco, CEO of CNS Pharmaceuticals Says: "Our preparations for filing an IND for Berubicin require continued execution in both our clinical and manufacturing initiatives, 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 BSP to prepare an injectable form of Berubicin for clinical use. BSP and Pii have now begun manufacturing of Berubicin and the Company expects to complete manufacturing at both locations early in the fourth quarter.

The FDA recently granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.

SOURCE CNS Pharmaceuticals, Inc

Related Posts

Subscribe Our Newsletter