We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by the European Union’s Horizon 2020 program. Led by Lipopharma, the multinational consortium brings together 12 academic and industry organizations from Europe, Israel, and the USA.
The group will use the award to execute the project “A Clinical Phase IIB trial with 2OHOA in patients with newly-diagnosed malignant glioma”. The double-blind, randomized adaptive trial will assess the efficacy and safety of 2OHOA in combination with radiotherapy and temozolomide in primary newly diagnosed glioblastoma patients and compare Progression Free Survival (PFS) between 3 treatment groups in 2 stages.
Cytel collaborated with Lipopharma and the consortium to create the innovative trial design and provided statistical input for the successful grant application. The design uses an interim analysis to determine the best dose and final sample size, while simultaneously investigating the molecular basis of patient subpopulations more likely to respond to 2OHOA treatment. It incorporates interim dose selection, sample size reassessment and biomarker threshold/omics signature determination features to achieve the trial’s objectives while assuring its integrity.
Lingyun Liu, Associate Director of Strategic Consulting at Cytel, said, "By combining dose optimization, sub-population detection, and biomarker determination objectives in a single study, this design makes the best use of available clinical data and effectively streamlines the development pathway.”
Yannis Jemiai, Senior Vice President at Cytel, added, “We are delighted that the CLINGLIO project has been awarded a Horizon 2020 grant to take this important trial forward. Glioma has an extremely poor prognosis and new, effective therapies are urgently required. Our team is proud to use its biostatistics expertise to help address the pressing unmet needs in this disease area.”
To learn more about the trial, which will recruit participants at sites in Europe and Israel, visit www.lipopharma.com.
Interested in learning more about applying adaptive approaches in oncology development? Click the button below to download Yannis Jemiai's article ' Are Adaptive Trials the Answer to Oncology Development Success?'