CNS Pharma Says FDA Oks Protocol Amendment To PPivotal Global Trial Of Berubicin For GBM

(RTTNews) - Biopharmaceutical company CNS Pharmaceuticals, Inc. (CNSP) announced Thursday 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.

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).

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.

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.

The FDA has granted CNS Pharmaceuticals Fast Track Designation and Orphan Drug Designation for Berubicin.