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CORDIS - Risultati della ricerca dell’UE
CORDIS

A Clinical Phase IIB trial with 2OHOA in patients with newly-diagnosed malignant glioma.

Obiettivo

"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."

Campo scientifico (EuroSciVoc)

CORDIS classifica i progetti con EuroSciVoc, una tassonomia multilingue dei campi scientifici, attraverso un processo semi-automatico basato su tecniche NLP. Cfr.: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.

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(si apre in una nuova finestra) H2020-SC1-2016-2017

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Bando secondario

H2020-SC1-2017-Two-Stage-RTD

Meccanismo di finanziamento

RIA -

Coordinatore

LAMINAR PHARMACEUTICALS SA
Contributo netto dell'UE
€ 2 985 285,09
Indirizzo
CTRA VALLEDEMOSSA KM.7,4 C/ ISSAC NEWTON, S/N BLOCK A, PLANTA 1, PUERTA 3, PARC BIT EDIFICIO NORTE
07121 PALMA DE MALLORCA
Spagna

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PMI

L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.

Regione
Este Illes Balears Mallorca
Tipo di attività
Entità private a scopo di lucro (esclusi istituti di istruzione secondaria o superiore)
Collegamenti
Costo totale
€ 2 985 285,09

Partecipanti (12)

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