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140 patients have been recruited at sites in Spain, Italy, France and United Kingdom.
The open readout of the trial is expected by late 2024.
Laminar aims to submit regulatory filings or conditional marketing authorization by early 2025.
PALMA DE MALLORCA, Spain, June 12, 2024 /PRNewswire/ -- Laminar Pharmaceuticals S.A., a clinical-stage biotechnological company developing novel therapies to treat diverse pathologies with unmet clinical needs, is pleased to announce the recruitment of patients for the CLINGLIO (NCT04250922) study has been closed after 140 adult patients have been successfully enrolled. The CLINGLIO study is a multinational, phase 2b/3, randomized, placebo-controlled, double-blind clinical trial evaluating idroxioleic acid in combination with Standard of Care (combined tumour resection and chemoradiotherapy) for the treatment of newly diagnosed glioblastoma patients. The CLINGLIO trial, funded by a European Commission Grant (H2020) is being carried out in 21 hospitals in Spain, Italy, France, and United Kingdom. The investigational study drug, idroxioleic acid (LAM561, sodium; 2-OHOA) is a synthetic fatty acid with a novel therapeutic approach, administrated orally to treat this devastating type of cancer.
"We are pleased to announce that the pivotal phase 2b/3 trial recruitment is completed, as this means that the results and outcome of the trial will be soon available," said Adrian McNicholl, Chief of Clinical Operations at Laminar Pharmaceuticals. The trial is expected to reach the trigger event for interim analysis in July 2024, which would provide an unblinded readout the last quarter of this year. "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, 19 years ago." These unblinded results will be submitted for EMA evaluation for Conditional Marketing Authorization in early 2025, and the trial will continue until final analysis of survival in 2026.
Pablo Escribá, CEO of Laminar Pharmaceuticals, said: "The completion of the recruitment is a huge milestone in our clinical trial and in the development of this potential new therapy for glioblastoma patients. We are excited about the possibility of offering a new treatment available for this fatal disease, which has some of the clearer unmet needs across the oncology field".
The CLINGLIO trial, which was initiated in December 2019, has enrolled 140 participants across 4 countries in Europe. Those patients were randomized 1:1 versus placebo. Idroxioleic acid or placebo is added to Standard of Care, and continued for as long as the tumour does not progress. Idroxioleic acid has shown a favorable safety profile in pre-clinical and clinical trials so far. Additionally, no safety concerns were raised by an Independent Data Monitoring Committee (IDMC) who recommended "continue without modifications" after unblinded reviews of the available safety and efficacy data. The trial will continue until the final analysis of overall survival.
The CLINGLIO trial is considered pivotal in that results showing significant clinical benefit could be sufficient for a request for conditional marketing authorization in the EU late this year; and potential full marketing authorization in 2026, for which enabling pre-submission interactions with the EMA have been initiated.
About Laminar Pharmaceuticals S.A.
Laminar Pharmaceuticals S.A. (Laminar) is a Spanish biotechnological company created in 2006, committed to translational health research, for the rational design and development of drugs to treat oncological and other pathologies in the form of synthetic fatty acids considered "First-in-class Health Solutions" and based on a novel technology, the Melitherapy (MLT or Membrane Lipid Therapy). Laminar controls all the processes, from the rational design of the molecules to the clinical trials that lead up to the launch of a new drug, with constant investment in R&D and high-quality standards. It is currently headquartered in Mallorca (Spain) with a subsidiary in Massachusetts (USA).
About Glioblastoma
Glioblastoma is the most common primary malignant brain tumour and accounts for nearly 50 percent of all gliomas and approximately 25 percent of all primary brain and CNS malignant tumours. The incidence of GBM in Europe is currently above 25,000 new cases each year, rising to over 100,000 cases per year worldwide. The prognosis for Glioblastoma patients is very poor, with a median survival time of about 14.5 months despite optimum chemo-radiation treatment. About 15% of patients survive two years after diagnosis and ca. 4% survive for five or more years. In this scenario, there is a desperate need for novel treatment alternatives that provide safe and more efficacious clinical outcomes.
About idroxioleic acid
Idroxioleic acid (LAM561; 2-hydroxyoleic acid (2-OHOA)) is a synthetic derivative of oleic acid and Laminar's most advanced R&D product, which is taken orally. This drug alters the composition of the plasma membrane in cancer cells, reducing the activity of membrane-associated signaling proteins that are known to promote tumour growth and affecting tumours in the brain. LAM561 is in the process of completing its last clinical development phase in adults and has shown promising preliminary clinical activity in the treatment of aggressive high-grade glioblastoma.