Obiettivo 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. Campo scientifico medical and health sciencesbasic medicinepharmacology and pharmacydrug discoverymedical and health scienceshealth sciencesinfectious diseases Programma(i) FP7-HEALTH - Specific Programme "Cooperation": Health Argomento(i) HEALTH.2012.2.4.4-1 - Preclinical and/or clinical development of substances with a clear potential as orphan drugs Invito a presentare proposte FP7-HEALTH-2012-INNOVATION-1 Vedi altri progetti per questo bando Meccanismo di finanziamento CP-FP - Small or medium-scale focused research project Coordinatore UNIVERSITE DE ROUEN NORMANDIE Contributo UE € 273 800,00 Indirizzo RUE THOMAS BECKET 1 MONT SAINT AIGNAN 76821 Mont Saint Aignan Cedex Francia Mostra sulla mappa Regione Normandie Haute-Normandie Seine-Maritime Tipo di attività Higher or Secondary Education Establishments Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato Partecipanti (5) Classifica in ordine alfabetico Classifica per Contributo UE Espandi tutto Riduci tutto S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA Italia Contributo UE € 716 503,00 Indirizzo VIA ERCOLE PATTI 36 LAVINAIO 36 95025 ACI SANT ANTONIO CT Mostra sulla mappa Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato RESEARCH TOXICOLOGY CENTRE - SPA Italia Contributo UE € 233 353,00 Indirizzo VIA TITO SPERI 12/14 00040 POMEZIA (Roma) Mostra sulla mappa Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST Regno Unito Contributo UE € 117 750,00 Indirizzo CITY ROAD 162 EC1V 2PD London Mostra sulla mappa Regione London Inner London — East Haringey and Islington Tipo di attività Research Organisations Collegamenti Contatta l’organizzazione Opens in new window Costo totale Nessun dato PSR Group BV Paesi Bassi Contributo UE € 2 437 169,00 Indirizzo Planetenweg 5 2132 HN HOOFDDORP Mostra sulla mappa Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato CERATIUM LIMITED Regno Unito Contributo UE € 271 680,00 Indirizzo THE HAVEN 20 BURLINGHAM AVENUE CH48 8AP West Kirby Mostra sulla mappa Regione North West (England) Merseyside Wirral Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato