CNS Pharmaceuticals, Inc. Receives Approval from Competent Authority of Switzerland for Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme
April 05, 2022 at 06:05 pm IST
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CNS Pharmaceuticals, Inc. announced it has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for the Company's potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM). With approvals now received from both swissethics, the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, and Swissmedic, the Company can proceed with site initiation and patient enrollment in Switzerland. 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. 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.
CNS Pharmaceuticals Inc. is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system (CNS). The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is in development for the treatment of a number of serious brain and CNS oncology indications, including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. In addition, the Company is advancing the development of its WP1244/WP1874 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents. The Company is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.
CNS Pharmaceuticals, Inc. Receives Approval from Competent Authority of Switzerland for Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme