ODAK

Orphan Drug for Acanthamoeba Keratitis

Coordinatore	UNIVERSITE DE ROUEN    more  Organization address address: RUE THOMAS BECKET 1 MONT SAINT AIGNAN city: MONT SAINT AIGNAN CEDEX postcode: 76821 contact info Titolo: Dr. Nome: Philippe Cognome: Moguérou Email: send email Telefono: +33 2 35 14 60 33
Nazionalità Coordinatore	France [FR]
Totale costo	5˙571˙493 €
EC contributo	4˙050˙255 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2012-INNOVATION-1
Funding Scheme	CP-FP
Anno di inizio	2012
Periodo (anno-mese-giorno)	2012-12-01   -   2017-11-30

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	UNIVERSITE DE ROUEN  Organization address address: RUE THOMAS BECKET 1 MONT SAINT AIGNAN city: MONT SAINT AIGNAN CEDEX postcode: 76821 contact info Titolo: Dr. Nome: Philippe Cognome: Moguérou Email: send email Telefono: +33 2 35 14 60 33	FR (MONT SAINT AIGNAN CEDEX)	coordinator	273˙800.00
2	PSR Group BV  Organization address address: Planetenweg 5 city: HOOFDDORP postcode: 2132 HN contact info Titolo: Dr. Nome: Roger Cognome: Legtenberg Email: send email Telefono: +31 23 5563221 Fax: +31 23 5563230	NL (HOOFDDORP)	participant	2˙437˙169.00
3	S.I.F.I. SOCIETA INDUSTRIA FARMACEUTICA ITALIANA SPA  Organization address address: VIA ERCOLE PATTI 36 LAVINAIO 36 city: ACI SANT ANTONIO CT postcode: 95025 contact info Titolo: Mr. Nome: Antonino Cognome: Asero Email: send email Telefono: 390958000000	IT (ACI SANT ANTONIO CT)	participant	716˙503.00
4	CERATIUM LIMITED  Organization address address: HOLLAND ROAD 41 city: WALLASEY postcode: CH45 7RA contact info Titolo: Dr. Nome: Ritchie Cognome: Head Email: send email Telefono: +44 151 3242413	UK (WALLASEY)	participant	271˙680.00
5	RESEARCH TOXICOLOGY CENTRE - SPA  Organization address address: VIA TITO SPERI 12/14 city: POMEZIA (Roma) postcode: 40 contact info Titolo: Dr. Nome: Morena Cognome: Cascone Email: send email Telefono: +39 0691095264	IT (POMEZIA (Roma))	participant	233˙353.00
6	MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST  Organization address address: City Road 162 city: LONDON postcode: EC1V 2PD contact info Titolo: Mr. Nome: Nick Cognome: Precious Email: send email Telefono: +44 20 7684 8574 Fax: +44 20 7684 8578	UK (LONDON)	participant	117˙750.00

Mappa

 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

 Obiettivo del progetto (Objective)

'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.'