CNS Pharmaceuticals is set to commence its pivotal trial of Berubicin to treat recurrent glioblastoma multiforme (GBM), an aggressive kind of brain cancer.
The move comes after the company obtained approval from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority and the CElm Provincial de Sevilla Ethics Committee in Spain.
Berubicin is a new anthracycline, which is a class of anticancer agents that are among the strong chemotherapy drugs.
It is claimed to be the first anthracycline to appear to transverse the blood-brain barrier.
The international, adaptive, multicentre, open-label, randomised and controlled trial will evaluate the efficacy and safety of Berubicin in adults with recurrent GBM (WHO Grade IV) following the failure of standard first-line treatment.
Nearly 243 GBM patients will be categorised into a 2:1 ratio to receive Berubicin or lomustine.
Assessing the overall survival is the trial’s primary endpoint.
Overall survival is an endpoint recognised by the US Food and Drug Administration (FDA) as a basis for approving cancer drugs when a statistically significant improvement versus randomised control arm is demonstrated.
After nearly 30-50% of all the trial subjects have concluded the primary endpoint at six months, the company will carry out a pre-planned, non-binding futility assessment.
This analysis will comprise further evaluation of safety and secondary efficacy endpoints.
CNS Pharmaceuticals CEO John Climaco said: “We continue to build momentum in our potentially pivotal study of Berubicin, and importantly advance toward bringing a much needed treatment option to patients.
“We have significantly bolstered our international presence and we are grateful to Spain for joining us in support of this trial. We are committed to driving this development program forward and are executing on all fronts to build momentum.”
In February 2020, CNS and WPD announced the launch a Phase I trial of Berubicin for paediatric brain cancer at the Children’s Memorial Health Institute in Poland.