CNS Pharmaceuticals Commences Patient Enrollment In Potentially Pivotal Study Of Berubicin

Study to evaluate efficacy and safety of Berubicin in the treatment of adult recurrent Glioblastoma Multiforme (GBM), one of the most aggressive types of brain cancer

Interim analysis of trial when 50% of planned subjects reach 6 months in study

Sublicensee, WPD Pharmaceuticals to initiate a Phase 2 multicenter clinical trial in Poland of Berubicin in GBM in the second half of 2021; Interim analysis of the first 18 adult patients expected in the first half of 2022

HOUSTON, May 19, 2021 /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 in the brain and central nervous system, today announced open enrollment for its potentially pivotal study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM.

(PRNewsfoto/CNS Pharmaceuticals, Inc.)

(PRNewsfoto/CNS Pharmaceuticals, Inc.)

CNS' lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to cross the blood-brain barrier. It is in development for the treatment of a number of serious brain and CNS oncology indications. The Company intends to enroll approximately 210 subjects across 35 clinical sites in the U.S. and also plans to expand the trial into western Europe. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

"We are delighted to begin patient enrollment and screening in this potentially pivotal trial that will provide greater insight into the potential of Berubicin to improve patient outcomes in the treatment of GBM. This represents an important milestone for our pivotal program," commented John Climaco, CEO of CNS Pharmaceuticals. "I would like to thank our clinical team for their commitment and drive to advance this important development program."

"There remains a critical unmet need in the treatment landscape for glioblastoma. The data seen to date from Berubicin is encouraging as a potential treatment option in this devastating disease. With patient enrollment now underway and dosing to commence soon hereafter, we are another step closer to providing patients with hope and treatment that offers improvement in progression and, importantly, overall survival," added Erin Dunbar, MD, founding physician of the Brain Tumor Center and Director of Neuro-Oncology at Piedmont Atlanta Hospital, and Principle Investigator for the study.

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