03K
Oral Off-patent Oncology Drugs for Kids
| Coordinatore | INSTITUT GUSTAVE ROUSSY
Organization address
address: Rue Camille Desmoulins 39 contact info |
| Nazionalità Coordinatore | France [FR] |
| Totale costo | 6˙836˙663 € |
| EC contributo | 5˙228˙003 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2007-B |
| Funding Scheme | CP-FP |
| Anno di inizio | 2008 |
| Periodo (anno-mese-giorno) | 2008-09-01 - 2011-08-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
INSTITUT GUSTAVE ROUSSY
Organization address
address: Rue Camille Desmoulins 39 contact info |
FR (VILLEJUIF) | coordinator | 2˙602˙030.00 |
| 2 | ORALANCE PHARMA S.A. | FR | participant | 840˙730.00 |
| 3 |
Keocyt SAS
Organization address
address: rue Chauvelot 29 contact info |
FR (MALAKOFF) | participant | 702˙110.00 |
| 4 |
UNIVERSITY OF NEWCASTLE UPON TYNE
Organization address
address: Kensington Terrace 6 contact info |
UK (NEWCASTLE UPON TYNE) | participant | 376˙201.00 |
| 5 |
Negositek
Organization address
city: Montpellier contact info |
FR (Montpellier) | participant | 324˙210.00 |
| 6 |
UNIVERSITA CATTOLICA DEL SACRO CUORE
Organization address
address: Largo Agostino Gemelli 1 contact info |
IT (MILANO) | participant | 149˙272.00 |
| 7 |
UNIVERSITY OF LEICESTER
Organization address
address: University Road contact info |
UK (LEICESTER) | participant | 127˙512.00 |
| 8 |
INSTITUTE OF CANCER RESEARCH - ROYAL CANCER HOSPITAL
Organization address
address: Old Brompton Road 123 contact info |
UK (LONDON) | participant | 54˙178.00 |
| 9 |
Nome Ente NON disponibile
Organization address
address: Route de Ganges 354 contact info |
FR (Montpellier) | participant | 51˙760.00 |
Mappa
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Obiettivo del progetto (Objective)
'There is an urgent need for appropriate oral formulations of anticancer drugs for the treatment of paediatric malignancies in children. The goal of the O3K consortium is to develop oral liquid formulations of Cyclophosphamide and Temozolomide, important chemotherapeutics which have been identified in the list of paediatric needs by EMEA (EMEA/197972/2007). Both off-patent drugs are widely used orally for the treatment of childhood cancer. However, the currently available tablets (Cyclophosphamide) and capsules (Temozolomide) are not suitable for use in a paediatric setting, particularly in infants and young children, as it is often impractical for them to be swallowed. This is a major health concern since these children do not readily have direct and safe access to these curative drugs. The NODS® technology represents an innovative oral drug delivery system for drinkable products for children. Drug entrapment in NODS® particles provides gastroprotection, stabilization, chemical protection of labile compounds and taste masking. O3K will conduct the pharmaceutical, clinical and pharmacological studies required for the development of these oral liquid formulations. Upon completion of the project, a dossier containing data required for application for a Paediatric Use Marketing Authorisation (PUMA) will be filed for both products. The EMEA Scientific Advice is already ongoing. O3K will provide access to curative drugs for all children with cancer, improving compliance, ensuring safety for both patient and environment and allowing the development of essential ambulatory treatments. In accordance with ICH guidelines, the development of these agents will lead to improved quality and safety of paediatric drug formulations. The O3K project involves 9 partners (including 5 institutions and 3 SMEs providing expertise in clinical and pharmacological research relating to paediatric oncology along with 1 parents organisation) from three European member states (UK, It and Fr)'