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CLINGLIO SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 CLINGLIO project word cloud

Explore the words cloud of the CLINGLIO project. It provides you a very rough idea of what is the project "CLINGLIO" about.

sawp773534    biomarkers    clinicaltrials    alternatives    authorisation    orphan    perform    innovative    switch    recruitment    synthase    statistically    basis    protein    aggressive    glioblastoma    protocol    ema    marketing    efficacious    formal    report    sa    patients    plausible    nct01792310    lipopharma    submitted    drug    discovery    cancer    man    lack    pe    designed    anticancer    context    repressor    brain    gov    action    sms1    mechanism    prevalence    rare    chmp    proliferation    identifier    months    personalized    conditional    advice    safety    treatments    lipid    glioma    form    showed    humans    demonstrates    written    positive    therapeutic    clinical    iib    highest    half    ratio    disease    sm    sme    sphingomyelin    indicates    prognosis    rates    treatment    inhabitants    obtain    tumor    membrane    multiforme    underlying    2014    diagnosis    designated    trial    molecular    molar    efficacy    assistance    transducers    therapies    agency    preclinical    2ohoa    activator    cell    scientific    iia    first    medicines    mortality    demonstrated    pa    gt    glp    approximately   

Project "CLINGLIO" data sheet

The following table provides information about the project.

Coordinator
LAMINAR PHARMACEUTICALS SL 

Organization address
address: CTRA VALLDEMOSSA KM 7,4 PARCBIT, EDIFICIO 17, INCU EMPRESAS, 2A PLANTA, MODULO C - 8
city: PALMA DE MALLORCA
postcode: 7121
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Spain [ES]
 Project website https://clinglio.eu/
 Total cost 6˙155˙125 €
 EC max contribution 6˙155˙125 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2017-Two-Stage-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-12-01   to  2020-11-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    LAMINAR PHARMACEUTICALS SL ES (PALMA DE MALLORCA) coordinator 2˙582˙500.00
2    SPECIALIZED MEDICAL SERVICES-ONCOLOGY BV NL (SCHIPHOL) participant 1˙212˙500.00
3    PRAXIS PHARMACEUTICAL SA ES (MINANO MAYOR) participant 1˙103˙500.00
4    UNIVERSITY OF NEWCASTLE UPON TYNE UK (NEWCASTLE UPON TYNE) participant 238˙750.00
5    RESEARCH FUND OF THE HADASSAH MEDICAL ORGANIZATION (R.A) IL (JERUSALEM) participant 222˙500.00
6    UNIVERSITAT DE LES ILLES BALEARS ES (PALMA DE MALLORCA) participant 195˙500.00
7    FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA IT (MILANO) participant 117˙000.00
8    INSTITUT GUSTAVE ROUSSY FR (VILLEJUIF) participant 117˙000.00
9    THE ROYAL MARSDEN NATIONAL HEALTH SERVICE TRUST UK (London) participant 117˙000.00
10    UNIVERSITA DEGLI STUDI DI SALERNO IT (FISCIANO SA) participant 101˙875.00
11    LIPODOM KUTATO FEJLESZTO ES TANACSADO KORLATOLT FELELOSSEGU TARSASAG HU (SZEGED) participant 97˙000.00
12    LANA MANAGEMENT AND BUSINESS RESEARCH INTERNATIONAL LLC US (ACTON, MASSACHUSETTS) participant 50˙000.00

Map

 Project objective

'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.'

 Deliverables

List of deliverables.
Protocols and laboratory manual for miRNAS, mRNA expression and RNAseq Documents, reports 2020-01-30 10:06:15
Consititution of the different management bodies Documents, reports 2020-01-30 10:06:15
Clinical Trial registration number Demonstrators, pilots, prototypes 2020-01-30 10:06:15
Sample protocols for liquid biopsy biomarkers Documents, reports 2020-01-30 10:06:15
Public Web Site and Project Presentation Other 2020-01-30 10:06:15
First regulatory approval of final version of study protocol Websites, patent fillings, videos etc. 2020-01-30 10:06:15
Protocols for protein biomarker determinations Documents, reports 2020-01-30 10:06:15

Take a look to the deliverables list in detail:  detailed list of CLINGLIO deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Wessal Massalha, Mark Markovits, Edward Pichinuk, Yael Feinstein-Rotkopf, Mark Tarshish, Kumudesh Mishra, Victoria Llado, Miguel Weil, Pablo V. Escriba, Or Kakhlon
Minerval (2-hydroxyoleic acid) causes cancer cell selective toxicity by uncoupling oxidative phosphorylation and compromising bioenergetic compensation capacity
published pages: BSR20181661, ISSN: 0144-8463, DOI: 10.1042/bsr20181661
Bioscience Reports 39/1 2020-01-30
2019 Francisca Guardiola-Serrano, Roberto Beteta-Göbel, Raquel Rodríguez-Lorca, Maitane Ibarguren, David J. López, Silvia Terés, María Alonso-Sande, Mónica Higuera, Manuel Torres, Xavier Busquets, Pablo V. Escribá
The triacylglycerol, hydroxytriolein, inhibits triple negative mammary breast cancer cell proliferation through a mechanism dependent on dihydroceramide and Akt
published pages: , ISSN: 1949-2553, DOI: 10.18632/oncotarget.26824
Oncotarget 10/26 2020-01-30
2019 Doralicia Casares, Pablo V. Escribá, Catalina Ana Rosselló
Membrane Lipid Composition: Effect on Membrane and Organelle Structure, Function and Compartmentalization and Therapeutic Avenues
published pages: 2167, ISSN: 1422-0067, DOI: 10.3390/ijms20092167
International Journal of Molecular Sciences 20/9 2020-01-30
2019 Paula Fernández-García, Catalina A. Rosselló, Raquel Rodríguez-Lorca, Roberto Beteta-Göbel, Javier Fernández-Díaz, Victoria Lladó, Xavier Busquets, Pablo V. Escribá
The Opposing Contribution of SMS1 and SMS2 to Glioma Progression and Their Value in the Therapeutic Response to 2OHOA
published pages: 88, ISSN: 2072-6694, DOI: 10.3390/cancers11010088
Cancers 11/1 2020-01-30

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