Spanish biotechnology company Laminar Pharmaceuticals has enrolled 140 adults in a Phase IIb/III clinical trial of idroxioleic acid (LAM561) regimen in treating newly diagnosed glioblastoma.
The CLINGLIO trial aims to assess idroxioleic acid plus standard of care (combined tumour resection and chemoradiotherapy) in glioblastoma patients.
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It is being funded by a European Commission Grant under the Horizon 2020 programme and conducted in 21 hospitals across Spain, France, Italy and the UK.
An interim analysis of the trial is scheduled for next month, with an unblinded readout expected to take place in the last quarter of this year.
The results will be submitted for the European Medicines Agency’s (EMA) evaluation ahead of conditional marketing authorisation early next year.
The trial will continue until the final analysis of survival in 2026.
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By GlobalDataSince its initiation in December 2019, the CLINGLIO trial has enrolled 140 participants from four European countries.
These patients were randomised in a 1:1 ratio to receive the treatment or a placebo alongside the standard of care until tumour progression was observed.
According to the Independent Data Monitoring Committee (IDMC), idroxioleic acid has demonstrated a favourable safety profile in pre-clinical and clinical trials thus far.
The IDMC has recommended the trial be continued without modifications following unblinded reviews of the available safety and efficacy data, as no safety concerns have been raised.
Laminar Pharmaceuticals Clinical Operations chief Adrian McNicholl said: “We are pleased to announce that the pivotal Phase IIb/III trial recruitment is completed, as this means that the results and outcome of the trial will be soon available.
“If idroxioleic acid is able to show compelling evidence demonstrating significant progression-free survival benefit with overall survival, it could imply the first addition to the standard of care for glioblastoma patients since the approval of temozolomide in 2005.”
