Berubicin is currently being evaluated in a global, potentially pivotal clinical trial The trial reached full enrollment in January 2023

This potentially pivotal trial is a multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. This study is fully enrolled with 252 patients and is not currently accepting additional patients.

The primary endpoint of the study is overall survival, 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.

Results from the trial will compare Berubicin to the current standard of care, with a 2:1 randomization to Berubicin or lomustine. We reached the criteria required by the study protocol to conduct this interim futility analysis, which an independent Data Safety Monitoring Board (“DSMB”) is responsible for conducting. The DSMB’s charter mandated that they review the primary endpoint, Overall Survival, as well as secondary endpoints and safety data to determine whether the efficacy data for the risk-benefit profile warrants modification or discontinuation of the study. On December 18, 2023, we released the DSMB’s recommendation which was to continue the study without modification.

For more details, visit ClinicalTrials.gov.