CNS Pharmaceuticals has announced the enrolment of more than 100 subjects in its potentially pivotal clinical trial of Berubicin for glioblastoma multiforme (GBM).
The company has launched 43 trial sites of the 60 sites selected across Italy, France, the US, Spain, and Switzerland.
An independent Data Safety Monitoring Board (DSMB) will conduct a pre-planned, non-binding futility analysis for recommending whether the study should continue as planned based on Berubicin showing value as a second-line treatment for GBM patients compared with Lomustine.
This analysis will be carried out after at least half of the patients to be analysed for the interim analysis can be assessed as having failed the primary efficacy endpoint (death).
A review will be performed by the DSMB with regard to the number of deaths in each arm for ensuring that the overall survival of patients receiving treatment with Berubicin shows at least a statistically significant comparability against those receiving Lomustine.
Comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments will be the additional analyses that will be provided based on the data.
During the interim analysis, the company will not pause subject enrolment.
CNS Pharmaceuticals CEO John Climaco said: “Enrolling over 100 patients in this relatively rare disease in a little more than 18 months is a remarkable achievement which speaks to the unmet clinical need in GBM and the excitement about Berubicin in the neuro-oncology clinical community worldwide.
“Lastly, having 100 patients in our study in Q2 2023 puts our interim analysis on target for Q3.”
The company’s lead product candidate Berubicin is a new anthracycline and is currently being evaluated in a potentially pivotal international study assessing its safety and efficacy to treat GBM.
The primary endpoint of this adaptive, multicentre, open-label, randomised controlled trial in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) is overall survival (OS).
Results from the trial will compare Berubicin to current SOC (Lomustine), with a randomisation of patients in 2:1 ratio to receive either Berubicin or Lomustine.