6.15 M€ Grant by the H2020 Programme to Conduct a PIIb Trial with 2OHOA in Patients with newly-diagnosed Glioblastoma

The European Commission (EC) has awarded a 6,15M€ grant to develop the project CLINGLIO to a multinational consortium lead by Lipopharma and integrated by 12 leading clinical research institutions, Universities and SMEs from Europe, Israel and the USA. The objective of CLINGLIO is the execution of "A Clinical Phase IIB trial with 2OHOA in patients with newly-diagnosed malignant glioma". The duration of the CLINGLIO project is 36 months and the starting date is 1st of December, 2017.

Palma de Mallorca (Spain) and Acton (MA, USA). January 21st 2017 [correct is 2018!]- Lipopharma, a pioneering clinical stage biopharmaceutical company developing a new generation of products modulating metabolism of membrane lipids based on the groundbreaking MLT platform, announces that the European Commission has awarded a 6,15M€ grant to the CLINGLIO consortium, lead by Lipopharma, to execute the project entitled "A Clinical Phase IIB trial with 2OHOA in patients with newly-diagnosed malignant glioma".

The CLINGLIO project was evaluated as a Research and Innovation Action (RIA) within the call H2020SC1-2017-Two-Stage-RTD, Topic SC1-PM-08-2017 (New Therapies for Rare Diseases), part of the Health, Demographic Change and Well-being Work Programme of the H2020. Total budget available for this H2020-SC1-2017-Two-Stage-RTD call was 173M€, of which 65M€ were for topic SC1-PM-082017. Overall, 668 proposals were submitted to this call, of which 37 were pre-selected for funding across the four topics of the call (5,5% of the initial proposals). In the New Therapies for Rare Diseases topic, the EC will select for funding up to 11 proposals with an average budget per project of around 6M€.

The grant was awarded to a multinational, well balanced consortium formed by 5 leading clinical research institutions in the UK (Royal Marsden Hospital and Northern Institute for Cancer Research, University of Newcastle upon Tyne), France (Institut Gustave Roussy), Italy (IstitutoNeurologico Carlo Besta) and Israel (Hadassah Medical Organization), two universities in Spain (Universitat de les IllesBalears, UIB) and Italy (UniversitadegliStudi di Salerno) and 4 specialized SMEs from The Netherlands (SMS Oncology, clinical CRO), Hungary (LipodomKft, lipidomic analysis), USA (LMBRI, pharmacoeconomics and market access) and Spain (Praxis Pharmaceutical, Drug product manufacturing and commercialization, and Lipopharma, coordinator and sponsor of the clinical trial).

The main objective of the CLINGLIO project is to execute a randomised, double-blind, placebocontrolled adjuvant trial in primary newly diagnosed glioblastoma patients to assess the efficacy and safety of 2OHOA in combination with radiotherapy and temozolomide. This study is a phase IIB trial with interim dose selection, sample size reassessment and biomarker threshold/omics signature determination. It is anticipated that around 15 clinical research hospitals across Europe and Israel will recruit 150 patients in the first part of the study, distributed in three arms: 1) control, with Standard of Care (SoC) plus placebo, 2) SoC plus 2OHOA "low dose" and 3) SoC plus 2OHOA "high dose". An interim analysis will take place after 75 events (Disease Progression) occurs and depending on the results of this interim analysis 60 to 120 additional patients will be enrolled in the second part of the study. The primary endpoint will be Progression Free Survival, according to RANO criteria, and Overall Survival will be a key secondary endpoint. If the results of this clinical trial are positive, Lipopharma plans to apply for a conditional approval of 2OHOA in Europe for the treatment of newly diagnosed GBM patients, in combination with radiotherapy and temozolomide.