CLINGLIO
Financiado
A Clinical Phase IIB trial with 2OHOA in patients with newly diagnosed malignant...
"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...
"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."
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Duración del proyecto: 54 meses
Fecha Inicio: 2017-11-27
Fecha Fin: 2022-05-31
Fecha Fin: 2022-05-31
Línea de financiación: concedida
El organismo H2020 notifico la concesión del proyecto el día 2022-05-31
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
SC1-PM-08-2017:
New therapies for rare diseases
Cerrada
hace 8 años
Presupuesto
El presupuesto total del proyecto asciende a
6M€
Líder del proyecto
LAMINAR PHARMACEUTICALS
La investigacion sobre temas de salud humana. el diseno e investigacion de farmacos y productos dieteticos para terapia humana y veterinaria...
Perfil tecnológico
TRL
3-4
130K
Perfil tecnológico
TRL
3-4
130K
117.00K€ |
Participante
1.21M€ |
Participante