CNS Pharmaceuticals Engages CRO For Phase 2 Berubicin Clinical Trials

The Company’s decision to engage Worldwide as its CRO for the upcoming Berubicin clinical trials is the latest milestone in a series of recent preparation achievements. The Company has been active in implementing its strategic plan and engaged US-based Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP) for the production of Berubicin drug product. The decision to add both Pii and BSP as manufacturers of Berubicin was part of the Company’s strategy to implement a dual-track drug product manufacturing strategy. The Company believes this dual-track strategy will help mitigate COVID-19 related risks, diversify its supply chain, and provide for localized availability of Berubicin. Furthermore, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.

About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

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