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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. €

0

Partnership

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Outcomes and
results

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 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.	ES (PALMA DE MALLORCA)	coordinator	2˙582˙500.00
2	SPECIALIZED MEDICAL SERVICES-ONCOLOGY BV SPECIALIZED MEDICAL SERVICES-ONCOLOGY BV Organization address address: WALAARDT SACRESTRAAT 401 city: SCHIPHOL postcode: 1117 BM 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.	NL (SCHIPHOL)	participant	1˙212˙500.00
3	PRAXIS PHARMACEUTICAL SA PRAXIS PHARMACEUTICAL SA Organization address address: HERMANOS LUMIERE 5 city: MINANO MAYOR postcode: 1510 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.	ES (MINANO MAYOR)	participant	1˙103˙500.00
4	UNIVERSITY OF NEWCASTLE UPON TYNE UNIVERSITY OF NEWCASTLE UPON TYNE Organization address address: KINGS GATE city: NEWCASTLE UPON TYNE postcode: NE1 7RU website: http://www.ncl.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWCASTLE UPON TYNE)	participant	238˙750.00
5	RESEARCH FUND OF THE HADASSAH MEDICAL ORGANIZATION (R.A) RESEARCH FUND OF THE HADASSAH MEDICAL ORGANIZATION (R.A) Organization address address: KIRYAT HADASSAH EIN KAREM city: JERUSALEM postcode: 91120 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.	IL (JERUSALEM)	participant	222˙500.00
6	UNIVERSITAT DE LES ILLES BALEARS UNIVERSITAT DE LES ILLES BALEARS Organization address address: CARRETERA DE VALLDEMOSSA KM 7.5 city: PALMA DE MALLORCA postcode: 7122 website: www.uib.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (PALMA DE MALLORCA)	participant	195˙500.00
7	FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA Organization address address: VIA GIOVANNI CELORIA 11 city: MILANO postcode: 20133 website: www.istituto-besta.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (MILANO)	participant	117˙000.00
8	INSTITUT GUSTAVE ROUSSY INSTITUT GUSTAVE ROUSSY Organization address address: Rue Camille Desmoulins 39 city: VILLEJUIF postcode: 94805 website: http://www.igr.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (VILLEJUIF)	participant	117˙000.00
9	THE ROYAL MARSDEN NATIONAL HEALTH SERVICE TRUST THE ROYAL MARSDEN NATIONAL HEALTH SERVICE TRUST Organization address address: Fulham Road 203-6 city: London postcode: SW3 6JJ website: www.royalmarsden.nhs.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (London)	participant	117˙000.00
10	UNIVERSITA DEGLI STUDI DI SALERNO UNIVERSITA DEGLI STUDI DI SALERNO Organization address address: VIA GIOVANNI PAOLO II 132 city: FISCIANO SA postcode: 84084 website: www.unisa.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (FISCIANO SA)	participant	101˙875.00
11	LIPODOM KUTATO FEJLESZTO ES TANACSADO KORLATOLT FELELOSSEGU TARSASAG LIPODOM KUTATO FEJLESZTO ES TANACSADO KORLATOLT FELELOSSEGU TARSASAG Organization address address: 35-37 DOROTTYA UTCA city: SZEGED postcode: 6726 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.	HU (SZEGED)	participant	97˙000.00
12	LANA MANAGEMENT AND BUSINESS RESEARCH INTERNATIONAL LLC LANA MANAGEMENT AND BUSINESS RESEARCH INTERNATIONAL LLC Organization address address: 360 MASSACHUSETTS AVENUE SUITE 203 city: ACTON, MASSACHUSETTS postcode: 1720 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.	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

List of publications.
year	authors and title	journal	last update
2019	Wessal Massalha, Mark Markovits, Edward Pichinuk, Yael Feinstein-Rotkopf, Mark Tarshish, Kumudesh Mishra, Victoria Llado, Miguel Weil, PabloÂ 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-GÃ¶bel, Raquel RodrÃguez-Lorca, Maitane Ibarguren, David J. LÃ³pez, Silvia TerÃ©s, MarÃa Alonso-Sande, MÃ³nica Higuera, Manuel Torres, Xavier Busquets, Pablo V. EscribÃ¡ 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. EscribÃ¡, Catalina Ana RossellÃ³ 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 FernÃ¡ndez-GarcÃa, Catalina A. RossellÃ³, Raquel RodrÃguez-Lorca, Roberto Beteta-GÃ¶bel, Javier FernÃ¡ndez-DÃaz, Victoria LladÃ³, Xavier Busquets, Pablo V. EscribÃ¡ 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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The information about "CLINGLIO" are provided by the European Opendata Portal: CORDIS opendata.

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