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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.

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

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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