Objetivo 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. Ámbito científico medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health scienceshealth sciencesinfectious diseases Programa(s) FP7-HEALTH - Specific Programme "Cooperation": Health Tema(s) HEALTH.2012.2.4.4-1 - Preclinical and/or clinical development of substances with a clear potential as orphan drugs Convocatoria de propuestas FP7-HEALTH-2012-INNOVATION-1 Consulte otros proyectos de esta convocatoria Régimen de financiación CP-FP - Small or medium-scale focused research project Coordinador UNIVERSITE DE ROUEN NORMANDIE Aportación de la UE € 273 800,00 Dirección RUE THOMAS BECKET 1 MONT SAINT AIGNAN 76821 Mont Saint Aignan Cedex Francia Ver en el mapa Región Normandie Haute-Normandie Seine-Maritime Tipo de actividad Higher or Secondary Education Establishments Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos Participantes (5) Ordenar alfabéticamente Ordenar por aportación de la UE Ampliar todo Contraer todo S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA Italia Aportación de la UE € 716 503,00 Dirección VIA ERCOLE PATTI 36 LAVINAIO 36 95025 ACI SANT ANTONIO CT Ver en el mapa Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos RESEARCH TOXICOLOGY CENTRE - SPA Italia Aportación de la UE € 233 353,00 Dirección VIA TITO SPERI 12/14 00040 POMEZIA (Roma) Ver en el mapa Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST Reino Unido Aportación de la UE € 117 750,00 Dirección CITY ROAD 162 EC1V 2PD London Ver en el mapa Región London Inner London — East Haringey and Islington Tipo de actividad Research Organisations Enlaces Contactar con la organización Opens in new window Coste total Sin datos PSR Group BV Países Bajos Aportación de la UE € 2 437 169,00 Dirección Planetenweg 5 2132 HN HOOFDDORP Ver en el mapa Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos CERATIUM LIMITED Reino Unido Aportación de la UE € 271 680,00 Dirección THE HAVEN 20 BURLINGHAM AVENUE CH48 8AP West Kirby Ver en el mapa Región North West (England) Merseyside Wirral Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos