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CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM

Expanded eligibility for patients who have received multiple therapies as first-line therapy for GBM. The company continues to enroll patients for the trial with 19 clinical trial sites open to date, and an additional 42 sites selected across the U.S., Italy, France, Spain, and Switzerland that will be initiated and enrolling soon. Interim analysis of the trial when 30- 50% of subjects reach 6 months in the study.

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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 that it has received approval from the U.S. Food and Drug Administration (FDA) for its ongoing potentially pivotal global study evaluating the efficacy and safety of Berubicin compared with Lomustine (Gleostine) administered after first line therapy for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.

“We are pleased to have received this positive response from the FDA and to continue driving the Berubicin clinical development program forward. The key objectives for the protocol amendment are based on the feedback we received from investigators and further consideration of the needs of patients on the study. We have also incorporated the recent WHO classification of glioblastoma1 with pertinent guidelines, ensuring that these patients meet specific criteria that allows us to accurately position the program for success. I am proud of the progress we continue to make on the clinical and regulatory fronts and look forward to further advancing this important trial,” commented John Climaco, CEO of CNS Pharmaceuticals.

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a global potentially pivotal study evaluating its efficacy and safety.

The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to a current standard of care (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment.

A pre-planned, non-binding futility analysis will be performed after 30 to 50% of all planned patients have completed 6 months on therapy. This evaluation will include safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

“The operational objectives of this study remain our priority, including using patient reported outcomes, stratification based on MGMT methylation status (a prognostic factor in glioblastomas), and providing both the study drug, Berubicin, as well as the comparator drug, Lomustine, to all sites. With the recent regulatory authority approvals received in Europe, we are currently on the cusp of opening clinical sites globally, including France, Italy, Spain, and Switzerland, to expand the scope and outreach to patients for this trial. We remain dedicated to driving this study forward and ultimately hope to provide a much-needed option for treatment in GBM as a safe and effective therapy,” added Sandra L. Silberman, M.D., Ph.D. Chief Medical Officer of CNS Pharmaceuticals.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with them to provide guidance on expediting the development and review process. Additionally, the Company has also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

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