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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

Total Cost €


EC-Contrib. €






 MIROCALS project word cloud

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

ld    il    safely    activates    investment    inflammatory    fatal    disease    interleukin    11    life    death    trial    significantly    blood    logical    drug    discovery    proof    nerve    modify    diabetes    cord    impasse    dose    cerebrospinal    showed    agents    possibilities    re    effect    outcome    hbc    neurodegenerative    therapeutic    immune    diseases    therapy    model    people    engineered    degenerative    course    hypothesis    outcomes    subsequent    regulatory    defective    individuals    neuroprotective    integrate    rates    mirocals    attempts    chronic    fluid    players    inflammation    failed    disorder    cell    deaths    spinal    contributes    opens    riluzole    vasculitis    function    modifying    tregs    cells    biomarkers    encourage    treg    care    damage    detected    causing    brain    sclerosis    versus    industry    patient    pioneering    ambition    break    quality    trials    lateral    host    als    breakthrough    progression    predict    decreased    mechanism    survival    fact    amyotrophic    graft   

Project "MIROCALS" data sheet

The following table provides information about the project.


Organization address
city: NIMES
postcode: 30900
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 France [FR]
 Project website
 Total cost 6˙510˙741 €
 EC max contribution 5˙980˙435 € (92%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2014-two-stage
 Funding Scheme RIA
 Starting year 2015
 Duration (year-month-day) from 2015-09-01   to  2021-09-30


Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
2    THE UNIVERSITY OF SUSSEX UK (BRIGHTON) participant 856˙330.00
3    ICON CLINICAL RESEARCH LIMITED IE (DUBLIN) participant 659˙105.00
4    THE UNIVERSITY OF SHEFFIELD UK (SHEFFIELD) participant 504˙408.00
5    KING'S COLLEGE LONDON UK (LONDON) participant 490˙790.00
6    WGK CONSULTANCY LTD UK (STEVENAGE) participant 476˙650.00
7    HUMANITAS MIRASOLE SPA IT (ROZZANO (MI)) participant 450˙000.00
8    INSERM - TRANSFERT SA FR (PARIS) participant 421˙000.00
9    ASSOCIATION GENETHON FR (EVRY) participant 373˙622.00
10    QUEEN MARY UNIVERSITY OF LONDON UK (LONDON) participant 159˙138.00
11    GOETEBORGS UNIVERSITET SE (GOETEBORG) participant 140˙500.00


 Project 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.


List of deliverables.
Approval from IRBs and Regulatory Agencies Documents, reports 2020-02-17 17:47:48
Corporate communication tools provided Demonstrators, pilots, prototypes 2020-02-17 17:47:48

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


year authors and title journal last update
List of publications.
2019 Jeremy A. Garson, Louise Usher, Ammar Al-Chalabi, Jim Huggett, Edmund F. Day, Adele L. McCormick
Quantitative analysis of human endogenous retrovirus-K transcripts in postmortem premotor cortex fails to confirm elevated expression of HERV-K RNA in amyotrophic lateral sclerosis
published pages: , ISSN: 2051-5960, DOI: 10.1186/s40478-019-0698-2
Acta Neuropathologica Communications 7/1 2020-04-15
2018 Jason A. Chen, Zhongbo Chen, Hyejung Won, Alden Y. Huang, Jennifer K. Lowe, Kevin Wojta, Jennifer S. Yokoyama, Gilbert Bensimon, P. Nigel Leigh, Christine Payan, Aleksey Shatunov, Ashley R. Jones, Cathryn M. Lewis, Panagiotis Deloukas, Philippe Amouyel, Christophe Tzourio, Jean-Francois Dartigues, Albert Ludolph, Adam L. Boxer, Jeff M. Bronstein, Ammar Al-Chalabi, Daniel H. Geschwind, Giovanni Cop
Joint genome-wide association study of progressive supranuclear palsy identifies novel susceptibility loci and genetic correlation to neurodegenerative diseases
published pages: , ISSN: 1750-1326, DOI: 10.1186/s13024-018-0270-8
Molecular Neurodegeneration 13/1 2020-02-17
2017 Sarah Morgan, Aleksey Shatunov, William Sproviero, Ashley R. Jones, Maryam Shoai, Deborah Hughes, Ahmad Al Khleifat, Andrea Malaspina, Karen E. Morrison, Pamela J. Shaw, Christopher E. Shaw, Katie Sidle, Richard W. Orrell, Pietro Fratta, John Hardy, Alan Pittman, Ammar Al-Chalabi
A comprehensive analysis of rare genetic variation in amyotrophic lateral sclerosis in the UK
published pages: 1611-1618, ISSN: 0006-8950, DOI: 10.1093/brain/awx082
Brain 140/6 2020-02-17
2016 Janine Kirby, Afnan Al Sultan, Rachel Waller, Paul Heath
The genetics of amyotrophic lateral sclerosis: current insights
published pages: 49, ISSN: 1179-9900, DOI: 10.2147/dnnd.s84956
Degenerative Neurological and Neuromuscular Disease 2020-02-17
2018 Martina de Majo, Simon D. Topp, Bradley N. Smith, Agnes L. Nishimura, Han-Jou Chen, Athina Soragia Gkazi, Jack Miller, Chun Hao Wong, Caroline Vance, Frank Baas, Anneloor L.M.A. ten Asbroek, Kevin P. Kenna, Nicola Ticozzi, Alberto Garcia Redondo, Jesús Esteban-Pérez, Cinzia Tiloca, Federico Verde, Stefano Duga, Karen E. Morrison, Pamela J. Shaw, Janine Kirby, Martin R. Turner, Kevin Talbot, Orla
ALS-associated missense and nonsense TBK1 mutations can both cause loss of kinase function
published pages: 266.e1-266.e10, ISSN: 0197-4580, DOI: 10.1016/j.neurobiolaging.2018.06.015
Neurobiology of Aging 71 2020-02-17
2017 Sarah Martin, Emma Trevor-Jones, Sabyha Khan, Keelan Shaw, Deepti Marchment, Anna Kulka, Catherine E Ellis, Rachel Burman, Martin R. Turner, Liam Carroll, Leah Mursaleen, P. Nigel Leigh, Christopher E. Shaw, Neil Pearce, Daniel Stahl, Ammar Al-Chalabi
The benefit of evolving multidisciplinary care in ALS: a diagnostic cohort survival comparison
published pages: 569-575, ISSN: 2167-8421, DOI: 10.1080/21678421.2017.1349151
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18/7-8 2020-02-17
2017 Alice Vajda, Russell L. McLaughlin, Mark Heverin, Owen Thorpe, Sharon Abrahams, Ammar Al-Chalabi, Orla Hardiman
Genetic testing in ALS
published pages: 991-999, ISSN: 0028-3878, DOI: 10.1212/WNL.0000000000003686
Neurology 88/10 2020-02-17
2017 Egor Dolzhenko, Joke J.F.A. van Vugt, Richard J. Shaw, Mitchell A. Bekritsky, Marka van Blitterswijk, Giuseppe Narzisi, Subramanian S. Ajay, Vani Rajan, Bryan R. Lajoie, Nathan H. Johnson, Zoya Kingsbury, Sean J. Humphray, Raymond D. Schellevis, William J. Brands, Matt Baker, Rosa Rademakers, Maarten Kooyman, Gijs H.P. Tazelaar, Michael A. van Es, Russell McLaughlin, William Sproviero, Aleksey Sha
Detection of long repeat expansions from PCR-free whole-genome sequence data
published pages: 1895-1903, ISSN: 1088-9051, DOI: 10.1101/gr.225672.117
Genome Research 27/11 2020-02-17
2017 Zhongbo Chen, Kuang Lin, Jeffrey D. Macklis, Ammar Al-Chalabi
Proposed association between the hexanucleotide repeat of C9orf72 and opposability index of the thumb
published pages: 175-181, ISSN: 2167-8421, DOI: 10.1080/21678421.2016.1257024
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 18/3-4 2020-02-17
2018 Ton Fang, Ahmad Al Khleifat, Jacques-Henri Meurgey, Ashley Jones, P Nigel Leigh, Gilbert Bensimon, Ammar Al-Chalabi
Stage at which riluzole treatment prolongs survival in patients with amyotrophic lateral sclerosis: a retrospective analysis of data from a dose-ranging study
published pages: 416-422, ISSN: 1474-4422, DOI: 10.1016/S1474-4422(18)30054-1
The Lancet Neurology 17/5 2020-02-17

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