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Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for anti-neuroinflammatory therapy in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients

Objective

Amyotrophic Lateral Sclerosis (ALS) is a fatal degenerative disorder of the brain and spinal cord affecting some 40,000 individuals in Europe, causing 11,000 deaths each year. Our pioneering work on riluzole showed that it is possible to modify ALS progression but all subsequent trials of potential neuroprotective agents have failed. Thus, drug development in ALS, including trial design, patient selection, and outcome measures must be re-engineered to break the current impasse. Nerve cell death in ALS is associated with inflammation, which contributes to cell damage, and is a logical target for therapy. Although therapeutic attempts to modify this have failed so far, the discovery of regulatory T cells (Tregs) as key players in controlling inflammatory processes opens new possibilities since defective Treg function is important in ALS. In fact, Treg numbers and function predict rates of disease progression and survival. Low-dose interleukin-2 (ld IL-2) safely and specifically increases and activates Tregs in conditions such as type 1 diabetes, HBc-vasculitis and chronic graft-versus-host disease, so ld IL-2 has the potential to significantly improve survival and deliver a therapeutic breakthrough in ALS. We also integrate biomarkers for nerve cell damage into the trial design to provide proof of concept/mechanism. “Modifying Immune Response and OutComes in ALS” (MIROCALS) will test the hypothesis that ld IL-2-induced increases in Tregs result in decreased rates of nerve cell damage and that this effect can be detected early in the course of the disease using a range of blood and cerebrospinal fluid biomarkers. Our ambition is to develop a new therapy for ALS and through this novel trial design break the impasse in drug development of other disease-modifying agents in ALS. The impact will be to enhance quality of life and care for people with ALS, and provide a robust model for Industry to encourage investment in ALS and other neurodegenerative diseases.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-two-stage

Coordinator

CENTRE HOSPITALIER UNIVERSITAIRE
Net EU contribution
€ 1 505 681,28
Address
Place Du Pr Robert Debre
30900 Nimes
France

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Region
Occitanie Languedoc-Roussillon Gard
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (14)

INSERM TRANSFERT SA
France
Net EU contribution
€ 421 000,00
Address
Rue Watt 7
75013 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ICON CLINICAL RESEARCH LIMITED
Ireland
Net EU contribution
€ 13 996,25
Address
South County Business Park Leopardstown
18 Dublin

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Region
Ireland Eastern and Midland Dublin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH (U.K.) LIMITED
United Kingdom
Net EU contribution
€ 217 555,00
Address
6 Stoneycroft Rise Chandlers Ford
SO533 LD Hampshire

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Region
South East (England) Hampshire and Isle of Wight South Hampshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH GMBH
Germany
Net EU contribution
€ 18 357,50
Address
Heinricht Hertz Strasse 26
63225 Langen

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Region
Darmstadt Offenbach, Landkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

ICON CLINICAL RESEARCH
France
Net EU contribution
€ 409 196,25
Address
55, Rue Des Champs Pierreux. Immeuble Le Capitole
92000 Nanterre

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Region
Ile-de-France Ile-de-France Hauts-de-Seine
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
ASSOCIATION GENETHON
France
Net EU contribution
€ 373 622,50
Address
Rue De L Internationale 1 Bis
91002 Evry

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Region
Ile-de-France Ile-de-France Essonne
Activity type
Research Organisations
Non-EU contribution
€ 0,00
HUMANITAS MIRASOLE SPA
Italy
Net EU contribution
€ 450 000,00
Address
Via Manzoni 56
20100 Rozzano (Mi)

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Region
Nord-Ovest Lombardia Milano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
GOETEBORGS UNIVERSITET
Sweden
Net EU contribution
€ 140 500,00
Address
Vasaparken
405 30 Goeteborg

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Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF SUSSEX
United Kingdom
Net EU contribution
€ 856 330,09
Address
Sussex House Falmer
BN1 9RH Brighton

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Region
South East (England) Surrey, East and West Sussex Brighton and Hove
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 478 695,70
THE UNIVERSITY OF SHEFFIELD
United Kingdom
Net EU contribution
€ 504 408,13
Address
Firth Court Western Bank
S10 2TN Sheffield

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Region
Yorkshire and the Humber South Yorkshire Sheffield
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
KING'S COLLEGE LONDON
United Kingdom
Net EU contribution
€ 490 790,00
Address
Strand
WC2R 2LS London

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Region
London Inner London — West Westminster
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
Net EU contribution
€ 159 138,75
Address
327 Mile End Road
E1 4NS London

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Region
London Inner London — East Tower Hamlets
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MOTOR NEURONE DISEASE ASSOCIATION
United Kingdom
Net EU contribution
€ 0,00
Address
10 15 Notre Dame Mews
NN1 2BG Northampton

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Region
East Midlands (England) Leicestershire, Rutland and Northamptonshire West Northamptonshire
Activity type
Other
Non-EU contribution
€ 51 611,25
WGK CONSULTANCY LTD
United Kingdom
Net EU contribution
€ 419 859,25
Address
29 Sish Lane
SG1 3LS Stevenage

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
East of England Bedfordshire and Hertfordshire Hertfordshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00