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

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.

Call for proposal

FP7-HEALTH-2012-INNOVATION-1
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Coordinator

FARON PHARMACEUTICALS OY
Address
Joukahaisenkatu 6
20520 Turku
Finland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 3 153 042
Administrative Contact
Markku Jalkanen (Prof.)

Participants (4)

UNIVERSITY COLLEGE LONDON HOSPITALSNHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 542 340
Address
Euston Road 250
NW1 2PG London
Activity type
Research Organisations
Administrative Contact
Geoff Bellingan (Dr.)
UNIVERSITA DEGLI STUDI DI TORINO

Participation ended

Italy
EU contribution
€ 132 117,94
Address
Via Giuseppe Verdi 8
10124 Torino
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marco Accossato (Mr.)
TURUN YLIOPISTO
Finland
EU contribution
€ 1 580 776
Address
Yliopistonmaki
20014 Turku
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Mari Riipinen (Dr.)
UNIVERSITA DEGLI STUDI DI ROMA LA SAPIENZA
Italy
EU contribution
€ 589 002,06
Address
Piazzale Aldo Moro 5
00185 Roma
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tommaso Progano (Dr.)