TRAUMAKINE

Interferon-beta treatment of acute respiratory distress syndrome (ARDS)

Coordinatore	FARON PHARMACEUTICALS OY    more  Organization address address: TYKISTOKATU 6 B city: TURKU postcode: 20520 contact info Titolo: Prof. Nome: Markku Cognome: Jalkanen Email: send email Telefono: 358405000000 Fax: 35824695152
Nazionalità Coordinatore	Finland [FI]
Totale costo	7˙817˙320 €
EC contributo	5˙997˙278 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2012-INNOVATION-1
Funding Scheme	CP-FP
Anno di inizio	2012
Periodo (anno-mese-giorno)	2012-12-01   -   2016-11-30

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	FARON PHARMACEUTICALS OY  Organization address address: TYKISTOKATU 6 B city: TURKU postcode: 20520 contact info Titolo: Prof. Nome: Markku Cognome: Jalkanen Email: send email Telefono: 358405000000 Fax: 35824695152	FI (TURKU)	coordinator	3˙153˙042.00
2	TURUN YLIOPISTO  Organization address address: YLIOPISTONMAKI city: TURUN YLIOPISTO postcode: 20014 contact info Titolo: Dr. Nome: Mari Cognome: Riipinen Email: send email Telefono: 35823336054 Fax: 35823336446	FI (TURUN YLIOPISTO)	participant	1˙580˙776.00
3	UNIVERSITA DEGLI STUDI DI ROMA LA SAPIENZA  Organization address address: Piazzale Aldo Moro 5 city: ROMA postcode: 185 contact info Titolo: Dr. Nome: Tommaso Cognome: Progano Email: send email Telefono: 390650000000 Fax: 39064469085	IT (ROMA)	participant	589˙002.06
4	UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST  Organization address address: EUSTON ROAD 250 city: LONDON postcode: NW1 2PG contact info Titolo: Dr. Nome: Geoff Cognome: Bellingan Email: send email Telefono: 442034000000 Fax: 442034000000	UK (LONDON)	participant	542˙340.00
5	UNIVERSITA DEGLI STUDI DI TORINO  Organization address address: Via Giuseppe Verdi 8 city: TORINO postcode: 10124 contact info Titolo: Mr. Nome: Marco Cognome: Accossato Email: send email Telefono: 390117000000	IT (TORINO)	participant	132˙117.94

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 Obiettivo del progetto (Objective)

'This application aims at a European marketing application for an orphan indication of the biopharmaceutical interferon-beta (IFN-beta) (EU3/07/505), to treat acute lunge injury (ALI) and acute respiratory distress syndrome (ARDS). Despite the much improved mechanical ventilation techniques and improved supportive therapies, ARDS kills 35-40 % of the 175.000 annual European patients. This condition has no approved pharmacological treatment in Europe. The applicant, Faron Pharmaceuticals, has recently finished a clinical phase I/II study with ALI/ARDS patients to obtain initial safety and pharmacokinetics for IFN-beta. Moreover, the study demonstrated very significant drop in all cause mortality of the IFN-beta treated patients at the day 28, the only accepted efficacy measurement as the primary end point for the treatment of ALI/ARDS. The pharmacological effect of IFN-beta is based on its ability to increase the de novo synthesis of endothelial cell surface anti-inflammatory molecule CD73, which can locally produce the enzymatic end product adenosine. Adenosine, in turn, increases endothelial barrier function and prevents the key step of ALI/ARDS process – vascular leakage. Faron and its clinical network will conduct a pan-European pivotal phase III study for further safety and pharmacokinetics of IFN-beta. If phase II reduction in all cause mortality of the IFN-beta treated ARDS patients can be replicated in a bigger study, the data would allow a marketing application for European regulatory authorities but also a much improved understanding what clinical parameters and biomarkers can attribute to the outcome of this deadly process in lungs. We also anticipate to harmonize European ARDS treatment and to create ARDS specific analytics for future ARDS diagnosis and treatment efficacy. ARDS patients represent massive cost burden to hospitals, societies and insurance companies. New medication for ALI/ARDS is much hoped and most welcome by intensive care doctors.'