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IEDAT SIGNED

Intra Erythrocyte Dexamethasone in the treatment of Ataxia Telangiectasia

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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 IEDAT project word cloud

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

monitoring    doses    hopkins    coordinated    administer    john    epidemiology    1st    genetic    biomarkers    ex    innovative    patients    life    performed    agreed    disease    double    nest    administered    closely    regulatory    fda    biomarker    center    randomized    molecular    chief    vivo    autologous    successful    validated    designed    predictive    investigations    history    parallel    monthly    guidelines    identification    ema    tested    ranges    international    phosphate    sodium    filing    therapy    university    erydex    provides    establishing    progressively    telangiectasia    efficacy    clinical    blind    registration    prospective    assessing    validation    neurological    dexamethasone    rare    placebo    infused    database    protocol    steroid    obtain    authorization    impairment    dose    disabling    centre    patient    trial    encapsulation    infusion    ataxia    reached    shortening    action    erydel    pivotal    natural    erythrocytes    market    maintaining    registry    usa    treatment    effect    2019    symptoms    mechanisms    first   

Project "IEDAT" data sheet

The following table provides information about the project.

Coordinator
EryDel S.p.A. 

Organization address
address: Via Meucci, 3
city: Bresso
postcode: 20091
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 Italy [IT]
 Project website http://iedat-project.eu/
 Total cost 5˙871˙825 €
 EC max contribution 5˙871˙825 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2015-two-stage
 Funding Scheme RIA
 Starting year 2016
 Duration (year-month-day) from 2016-01-01   to  2021-02-28

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    EryDel S.p.A. IT (Bresso) coordinator 4˙331˙575.00
2    Universita' degli Studi di Urbino Carlo Bo IT (URBINO) participant 400˙000.00
3    MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER IL (RAMAT GAN) participant 270˙000.00
4    JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN DE (FRANKFURT AM MAIN) participant 256˙250.00
5    THE ATAXIA-TELANGIECTASIA SOCIETY UK (HARPENDEN) participant 254˙000.00
6    JOHNS HOPKINS UNIVERSITY US (BALTIMORE) participant 217˙500.00
7    AK GROUP FR (ANGERS) participant 142˙500.00
8    ABSISKEY FR (ANGERS) participant 0.00
9    ABSISKEY CP FR (GRENOBLE) participant 0.00

Map

 Project objective

The main objective of the project is to provide a treatment of the neurological symptoms of patients with Ataxia Telangiectasia (AT), a rare progressively disabling and life-shortening genetic disease for which no therapy is currently available. To achieve this, a pivotal Phase III study will be conducted, to allow regulatory filing to obtain market authorization in EU and USA by 2019. EryDex is an innovative product, developed by EryDel, used to administer dexamethasone sodium phosphate by ex-vivo encapsulation in autologous erythrocytes, which are infused into the patient. EryDex provides long-term delivery of low doses of dexamethasone without the typical steroid side effects and has reached a successful Phase II trial conducted in AT patients. The phase III trial will be an international, multi-center, 1 year, randomized, prospective, double-blind, placebo-controlled, designed to assess the effect of 2 dose ranges of EryDex, administered monthly by IV infusion, on neurological symptoms of AT patients. The protocol of the trial and the regulatory path to registration has already been agreed upon with EMA and FDA. An international patient registry will also be set with the aim of establishing and maintaining a comprehensive clinical database of patients with AT and closely related conditions, enabling the monitoring of AT epidemiology, the development of an evidence-based natural history of the condition, identification of biomarkers as well as development of clinical guidelines. The AT NEST, the first scale to assess symptoms specific to AT patients, coordinated by the AT centre at the John’s Hopkins University, will be tested in the study and if validated will represent the 1st scale assessing chief areas of impairment specific to AT. In parallel to the clinical trial, investigations into the molecular mechanisms of action of EryDex will be performed with the objective to provide the validation of a new biomarker predictive of treatment efficacy.

 Deliverables

List of deliverables.
Dissemination materials Websites, patent fillings, videos etc. 2020-04-09 09:40:08
Registration number of clinical study in approved registry Documents, reports 2020-04-09 09:40:08
Registry database Other 2020-04-09 09:40:08
Project website (IEDAT) Websites, patent fillings, videos etc. 2020-04-09 09:40:08
Report on AT NEST definition, guidelines and SOPs Documents, reports 2020-04-09 09:40:08
First evaluation workshop Documents, reports 2020-04-09 09:40:08

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

 Publications

year authors and title journal last update
List of publications.
2017 Giovanni Mambrini, Marco Mandolini, Luigia Rossi, Francesca Pierigè, Giovanni Capogrossi, Patricia Salvati, Sonja Serafini, Luca Benatti, Mauro Magnani
Ex vivo encapsulation of dexamethasone sodium phosphate into human autologous erythrocytes using fully automated biomedical equipment
published pages: 175-184, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2016.12.011
International Journal of Pharmaceutics 517/1-2 2020-04-09
2018 Michele Menotta, Sara Biagiotti, Sara Orazi, Luigia Rossi, Luciana Chessa, Vincenzo Leuzzi, Daniela D’Agnano, Alessandro Plebani, Annarosa Soresina, Mauro Magnani
In vivo effects of dexamethasone on blood gene expression in ataxia telangiectasia
published pages: 153-166, ISSN: 0300-8177, DOI: 10.1007/s11010-017-3122-x
Molecular and Cellular Biochemistry 438/1-2 2020-04-09

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