The potentially pivotal, randomised, adaptive, multicentre, open-label and controlled trial will enrol adult subjects with recurrent GBM (WHO Grade IV1) who have failed standard first-line treatment.
It will analyse Berubicin against an existing standard of care of Lomustine by randomising the subjects into a 2:1 ratio to receive either Berubicin or Lomustine.
Of the 68 clinical trial sites chosen across the US, France, Italy, Spain, and Switzerland, 29 sites were opened to date.
Overall survival is the trial’s primary endpoint.
The company intends to carry out a non-binding futility assessment after nearly 30% to 50% of all planned subjects have concluded the trial’s primary endpoint at six months.
This analysis will comprise further safety and secondary efficacy endpoints evaluation.
Subject enrolment will not be halted while carrying out the interim review.
A new anthracycline, Berubicin is the first of its kind to appear to cross the blood-brain barrier.
CNS Pharmaceuticals CEO John Climaco said: “To have enrolled and dosed our first patient in France shortly after the opening of the site is a noteworthy accomplishment and a testament to our team’s dedication to drive the programme forward.
“We expect to enrol and dose additional patients across our clinical trial sites in Europe and advance toward the much-anticipated inflection point which is the interim analysis.”
Berubicin previously secured Fast Track and Orphan Drug designations from the Food and Drug Administration (FDA).
In September this year, the company opened the first European sites for the trial of Berubicin to treat recurrent GBM.