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Financement de l’UE (6 155 125 €) : Un essai clinique de phase IIB avec 2OHOA chez des patients atteints d’un gliome malin nouvellement diagnostiqué. Hor01/12/2017 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Un essai clinique de phase IIB avec 2OHOA chez des patients atteints d’un gliome malin nouvellement diagnostiqué.
"Glioma is a rare brain cancer with one of the highest mortality rates. It is considered an orphan disease due to its low prevalence (less than 0.5 cases per 10,000 inhabitants in the EU) and the lack of plausible therapies. Based on the discovery of the lipid proliferation switch (high membrane PE-to-SM molar ratio that enables recruitment of cell growth transducers to the membrane), the SME Lipopharma (leading this application) defined a novel anticancer drug target, the tumor repressor protein sphingomyelin synthase 1 (SMS1). An innovative SMS1 activator, 2OHOA, was designed and showed safety and efficacy in preclinical GLP and non-GLP studies. A first-in-man clinical trial I/IIa (ClinicalTrials.gov identifier #NCT01792310) further demonstrated its safety and efficacy in humans. The European Medicines Agency (EMA) designated 2OHOA orphan drug for the treatment of glioma and approximately half of the patients with glioma submitted to >2 months of treatment showed positive response. The present project aims to perform a clinical phase IIB study to demonstrate 2OHOA’s efficacy against glioblastoma multiforme, the most aggressive form of glioma. In this context, a written formal report from the EMA after scientific advice and protocol assistance (SA/PA-EMA/CHMP/SAWP773534/2014) indicates that 2OHOA would obtain Conditional Marketing Authorisation if this phase-IIB study further demonstrates statistically significant efficacy. In addition this project will further investigate 2OHOA’s safety, mechanism of action and biomarkers for glioblastoma diagnosis, prognosis and response to 2OHOA treatment. These studies will let us (i) know the molecular basis underlying the response to 2OHOA treatment, (ii) define new biomarkers, (iii) design more efficacious personalized treatments and (iv) investigate therapeutic alternatives in patients who do not respond to treatment."
| Biokeralty Research Institute AIE | 0,00 € |
| Fondazione Irccs Istituto Neurologico Carlo Besta | 117 000 € |
| Institut Gustave Roussy | 117 000 € |
| Laminar Pharmaceuticals SA | 2 985 285 € |
| LANA MANAGEMENT AND BUSINESS RESEARCH INTERNATIONAL LLC | 50 000 € |
| LIPODOM KUTATO FEJLESZTO ES TANACSADO kft. | 97 000 € |
| Praxis Pharmaceutical SA | 700 715 € |
| RESEARCH FUND OF THE HADASSAH MEDICAL ORGANIZATION (RA) | 222 500 € |
| SPECIALIZED MEDICAL SERVICES-ONCOLOGY B.V. | 1 212 500 € |
| The Royal Marsden National Health Service Trust | 117 000 € |
| Universita Degli Studi Di Salerno | 101 875 € |
| Universitat de les Illes Balears | 195 500 € |
| University of Newcastle Upon Tyne | 238 750 € |
https://cordis.europa.eu/project/id/755179
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