Objectif 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. Champ scientifique medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health scienceshealth sciencesinfectious diseases Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH.2012.2.4.4-1 - Preclinical and/or clinical development of substances with a clear potential as orphan drugs Appel à propositions FP7-HEALTH-2012-INNOVATION-1 Voir d’autres projets de cet appel Régime de financement CP-FP - Small or medium-scale focused research project Coordinateur UNIVERSITE DE ROUEN NORMANDIE Contribution de l’UE € 273 800,00 Adresse RUE THOMAS BECKET 1 MONT SAINT AIGNAN 76821 Mont Saint Aignan Cedex France Voir sur la carte Région Normandie Haute-Normandie Seine-Maritime Type d’activité Higher or Secondary Education Establishments Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Participants (5) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA Italie Contribution de l’UE € 716 503,00 Adresse VIA ERCOLE PATTI 36 LAVINAIO 36 95025 ACI SANT ANTONIO CT Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée RESEARCH TOXICOLOGY CENTRE - SPA Italie Contribution de l’UE € 233 353,00 Adresse VIA TITO SPERI 12/14 00040 POMEZIA (Roma) Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST Royaume-Uni Contribution de l’UE € 117 750,00 Adresse CITY ROAD 162 EC1V 2PD London Voir sur la carte Région London Inner London — East Haringey and Islington Type d’activité Research Organisations Liens Contacter l’organisation Opens in new window Coût total Aucune donnée PSR Group BV Pays-Bas Contribution de l’UE € 2 437 169,00 Adresse Planetenweg 5 2132 HN HOOFDDORP Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée CERATIUM LIMITED Royaume-Uni Contribution de l’UE € 271 680,00 Adresse THE HAVEN 20 BURLINGHAM AVENUE CH48 8AP West Kirby Voir sur la carte Région North West (England) Merseyside Wirral Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée
