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MIROCALS SIGNED

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 €

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EC-Contrib. €

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Partnership

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 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.

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

Project "MIROCALS" data sheet

The following table provides information about the project.

Coordinator
CENTRE HOSPITALIER UNIVERSITAIRE 

Organization address
address: PLACE DU PR ROBERT DEBRE
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 http://www.mirocals.eu/
 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

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    CENTRE HOSPITALIER UNIVERSITAIRE FR (NIMES) coordinator 1˙448˙890.00
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
12    MOTOR NEURONE DISEASE ASSOCIATION UK (NORTHAMPTON) participant 0.00

Map

 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.

 Deliverables

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.

 Publications

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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