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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
- social sciences sociology demography mortality
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- medical and health sciences basic medicine pharmacology and pharmacy pharmacokinetics
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
FP7-HEALTH-2012-INNOVATION-1
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Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
20520 Turku
Finland
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.