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IEDAT SIGNED

Intra Erythrocyte Dexamethasone in the treatment of Ataxia Telangiectasia

Total Cost €

0

EC-Contrib. €

0

Partnership

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Outcomes and
results

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.

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

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. 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.	IT (Bresso)	coordinator	4˙331˙575.00
2	Universita' degli Studi di Urbino Carlo Bo Universita' degli Studi di Urbino Carlo Bo Organization address address: Via Aurelio Saffi 2 city: URBINO postcode: 61029 website: www.uniurb.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (URBINO)	participant	400˙000.00
3	MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER Organization address address: TEL HASHOMER SHEBA MEDICAL CENTER city: RAMAT GAN postcode: 52621 website: http://www.sheba.co.il contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IL (RAMAT GAN)	participant	270˙000.00
4	JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN Organization address address: THEODOR W ADORNO PLATZ 1 city: FRANKFURT AM MAIN postcode: 60323 website: www.uni-frankfurt.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (FRANKFURT AM MAIN)	participant	256˙250.00
5	THE ATAXIA-TELANGIECTASIA SOCIETY THE ATAXIA-TELANGIECTASIA SOCIETY Organization address address: IACR ROTHAMSTED city: HARPENDEN postcode: AL5 2JQ 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.	UK (HARPENDEN)	participant	254˙000.00
6	JOHNS HOPKINS UNIVERSITY JOHNS HOPKINS UNIVERSITY Organization address address: NORTH CHARLES STREET 3400 city: BALTIMORE postcode: 21218 website: www.hopkinsmedicine.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (BALTIMORE)	participant	217˙500.00
7	AK GROUP AK GROUP Organization address address: 41B RUE DUPETIT THOUARS city: ANGERS postcode: 49000 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.	FR (ANGERS)	participant	142˙500.00
8	ABSISKEY ABSISKEY Organization address address: 41B RUE DUPETIT-THOUARS city: ANGERS postcode: 49000 website: http://www.absiskey.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (ANGERS)	participant	0.00
9	ABSISKEY CP ABSISKEY CP Organization address address: RUE COLONEL DUMONT 26 city: GRENOBLE postcode: 38000 website: www.absiskey.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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

List of publications.
year	authors and title	journal	last update
2017	Giovanni Mambrini, Marco Mandolini, Luigia Rossi, Francesca PierigÃ¨, 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 Dâ€™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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The information about "IEDAT" are provided by the European Opendata Portal: CORDIS opendata.

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