Benzinga | Dec 2, 2021 08:36AM EST

CNS Pharma Reports Received Approval From Switzerland Ethics Committee For Pivotal Study Of Berubicin For Treatment Of Glioblastoma Multiforme

Approval is the first from a European Ethics Committee for the potentially pivotal study of Berubicin with additional sites selected across the U.S., Italy, France, and Spain, expected to initiate imminently

HOUSTON, Dec. 2, 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 it has received approval from swissethics, the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, for the Company's potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.



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

"Receiving approval from swissethics is a significant milestone for the Company. Our stated goal is, and always has been, to see Berubicin approved for the treatment of glioblastoma, and this means globally. This terrible disease does not discriminate on the basis of geography or anything else: Patients in Europe are as desperate as patients in the United States, and treating patients is not only why we do what we do, but how we do it as well. Driving patient enrollment is how we advance Berubicin's development and opening additional clinical sites around the globe is the pivotal piece that allows us to ramp up our efforts and move toward data. We are deeply grateful that Switzerland has the first European EC to approve our Berubicin trial, but we are confident it will be far from the last in this truly global effort. We have a number of additional clinical sites selected around the world that we anticipate coming online in the very near term. As we progress, my belief grows in the enormous potential of Berubicin to be a critical treatment option for this devastating disease. I am proud of the accomplishments we've made with this potentially pivotal trial to-date, but we will not pause for a single second until Berubicin reaches its full potential to offer hope to GBM patients everywhere," commented John Climaco, CEO of CNS Pharmaceuticals.

The potentially pivotal global 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. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (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.

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

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company 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.