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Orphan Drug for Acanthamoeba Keratitis

Cel

This project will undertake preclinical and clinical research of the Orphan Drug Polihexanide (PHMB). The main objective is to provide a safe and effective drug for the treatment of the rare ocular disease Acanthamoeba keratitis (AK) tested according to international regulatory standards. This debilitating infectious disease is caused by a free living protozoan which, in the absence of treatment, can have catastrophic consequences such as severe pain, visual loss and eye enucleation. There are no approved drugs to treat this disease. After Orphan Drug Designation Protocol Assistance was requested from the European Medicines Agency on our drug development research plan. The proposed protocol incorporates the EMA advice and will include a non-clinical phase, a double-blind placebo controlled Phase I trial and a randomised double-blind, active controlled, parallel groups Phase 3 study (efficacy and safety therapeutic confirmatory study). The primary deliverables will be: 1) experimental scientific evidence on the quality, safety and efficacy of PHMB to provide the basis for a Marketing Authorisation within 5 years; 2) recommendations aiming to improve clinical practices in the management of AK based on the efficacy and safety evidence. ODAK is an industry led project mobilising the critical mass of industrial, pharmaceutical and academic expertise. needed to develop and optimise therapeutic approaches to alleviate the severe negative impacts of AK on the health and quality of life of patients. In particular, through identifying optimal PHMB formulations and recommending the best dose-benefit treatment regimes. ODAK directly contributes to the International Rare Diseases Research Consortium goal towards 200 new therapies. An estimated 95% of the total estimated EU contribution to the project will go to industrial partners (of this 32% goes to SMEs). The industrial strength assures a rapid translation of research to market application.

Zaproszenie do składania wniosków

FP7-HEALTH-2012-INNOVATION-1
Zobacz inne projekty w ramach tego zaproszenia

System finansowania

CP-FP - Small or medium-scale focused research project

Koordynator

UNIVERSITE DE ROUEN NORMANDIE
Adres
Rue Thomas Becket 1 Mont Saint Aignan
76821 Mont Saint Aignan Cedex
Francja
Rodzaj działalności
Higher or Secondary Education Establishments
Wkład UE
€ 273 800
Kontakt administracyjny
Philippe Moguérou (Dr.)

Uczestnicy (5)

S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA
Włochy
Wkład UE
€ 716 503
Adres
Via Ercole Patti 36 Lavinaio 36
95025 Aci Sant Antonio Ct
Rodzaj działalności
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt administracyjny
Antonino Asero (Mr.)
RESEARCH TOXICOLOGY CENTRE - SPA
Włochy
Wkład UE
€ 233 353
Adres
Via Tito Speri 12/14
00040 Pomezia (Roma)
Rodzaj działalności
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt administracyjny
Morena Cascone (Dr.)
MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST
United Kingdom
Wkład UE
€ 117 750
Adres
City Road 162
EC1V 2PD London
Rodzaj działalności
Research Organisations
Kontakt administracyjny
Nick Precious (Mr.)
PSR Group BV
Niderlandy
Wkład UE
€ 2 437 169
Adres
Planetenweg 5
2132 HN Hoofddorp
Rodzaj działalności
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt administracyjny
Roger Legtenberg (Dr.)
CERATIUM LIMITED
United Kingdom
Wkład UE
€ 271 680
Adres
The Haven 20 Burlingham Avenue
CH48 8AP West Kirby
Rodzaj działalności
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Kontakt administracyjny
Ritchie Head (Dr.)