CNS Pharmaceuticals has activated the first European study sites for the clinical trial of Berubicin to treat recurrent glioblastoma multiforme (GBM), a type of brain cancer.
These sites in France and Spain are currently open and enrolling subjects.
The adaptive, multicentre, ongoing, international, open-label, randomised, controlled trial is enrolling adults with recurrent GBM (WHO Grade IV1) following standard first-line therapy failure.
Overall Survival (OS) is the primary endpoint of the trial.
Trial subjects will be randomised into a 2:1 ratio to receive either Berubicin or Lomustine, which is the existing standard of care.
At present, subject enrolment is advancing at 26 trial sites of the 59 sites chosen in the US, France, Italy, Switzerland, and Spain.
The company plans to carry out a non-binding futility assessment on 30% to 50% of trial subjects concluding the primary endpoint at six months.
This review will comprise further analysis of safety and secondary efficacy endpoints.
CNS will not halt subject enrolment in the trial during the interim assessment.
A new anthracycline, Berubicin is claimed to cross the blood-brain barrier.
It has obtained Fast Track Designation and Orphan Drug Designation from the US Food and Drug Administration.
Berubicin showed to offer positive responses, including a durable complete response in patients with brain cancer, in a Phase I trial carried out by Reata Pharmaceuticals.
In April this year, the company announced plans to begin the trial of Berubicin for recurrent GBM in Spain.
The move came after CNS received approval from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority and the CElm Provincial de Sevilla Ethics Committee in the country.