CORDIS
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CORDIS

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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

Objectif

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.

Coordinateur

CENTRE HOSPITALIER UNIVERSITAIRE

Adresse

Place Du Pr Robert Debre
30900 Nimes

France

Type d’activité

Research Organisations

Contribution de l’UE

€ 1 448 890,33

Participants (11)

Trier par ordre alphabétique

Trier par contribution de l’UE

Tout développer

INSERM - TRANSFERT SA

France

Contribution de l’UE

€ 421 000

ICON CLINICAL RESEARCH LIMITED

Irlande

Contribution de l’UE

€ 659 105

ASSOCIATION GENETHON

France

Contribution de l’UE

€ 373 622,50

HUMANITAS MIRASOLE SPA

Italie

Contribution de l’UE

€ 450 000

GOETEBORGS UNIVERSITET

Suède

Contribution de l’UE

€ 140 500

THE UNIVERSITY OF SUSSEX

Royaume-Uni

Contribution de l’UE

€ 856 330,09

THE UNIVERSITY OF SHEFFIELD

Royaume-Uni

Contribution de l’UE

€ 504 408,13

KING'S COLLEGE LONDON

Royaume-Uni

Contribution de l’UE

€ 490 790

QUEEN MARY UNIVERSITY OF LONDON

Royaume-Uni

Contribution de l’UE

€ 159 138,75

MOTOR NEURONE DISEASE ASSOCIATION

Royaume-Uni

WGK CONSULTANCY LTD

Royaume-Uni

Contribution de l’UE

€ 476 650,20

Informations projet

N° de convention de subvention: 633413

État

Projet en cours

  • Date de début

    1 Septembre 2015

  • Date de fin

    30 Septembre 2021

Financé au titre de:

H2020-EU.3.1.3.

  • Budget total:

    € 6 510 741,95

  • Contribution de l’UE

    € 5 980 435

Coordonné par:

CENTRE HOSPITALIER UNIVERSITAIRE

France