03K

Oral Off-patent Oncology Drugs for Kids

Coordinatore	INSTITUT GUSTAVE ROUSSY    more  Organization address address: Rue Camille Desmoulins 39 city: VILLEJUIF postcode: 94805 contact info Titolo: Mr. Nome: Arnauld Cognome: Forest Email: send email Telefono: 33142116604 Fax: 33142116160
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

#	participant	country	role	EC contrib. [€]
1	INSTITUT GUSTAVE ROUSSY  Organization address address: Rue Camille Desmoulins 39 city: VILLEJUIF postcode: 94805 contact info Titolo: Mr. Nome: Arnauld Cognome: Forest Email: send email Telefono: 33142116604 Fax: 33142116160	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 city: MALAKOFF postcode: 92240 contact info Titolo: Dr. Nome: Christophe Michel Cognome: Pasik Email: send email Telefono: -42310679 Fax: -42312347	FR (MALAKOFF)	participant	702˙110.00
4	UNIVERSITY OF NEWCASTLE UPON TYNE  Organization address address: Kensington Terrace 6 city: NEWCASTLE UPON TYNE postcode: NE1 7RU contact info Titolo: Ms. Nome: Nicola Cognome: Place Email: send email Telefono: +44 191 222 5324 Fax: +44 191 222 5920	UK (NEWCASTLE UPON TYNE)	participant	376˙201.00
5	Negositek  Organization address city: Montpellier postcode: 34000 contact info Titolo: Dr. Nome: Olivier Cognome: Saslawski Email: send email Telefono: 33670344534	FR (Montpellier)	participant	324˙210.00
6	UNIVERSITA CATTOLICA DEL SACRO CUORE  Organization address address: Largo Agostino Gemelli 1 city: MILANO postcode: 20123 contact info Titolo: Dr. Nome: Franco Cognome: Mariotti Email: send email Telefono: 0039 6 30155272 Fax: 0039 6 30156803	IT (MILANO)	participant	149˙272.00
7	UNIVERSITY OF LEICESTER  Organization address address: University Road city: LEICESTER postcode: LE1 7RH contact info Titolo: Ms. Nome: Marie Cognome: Singer Email: send email Telefono: +44 116 223 1799 Fax: +44 116 252 2028	UK (LEICESTER)	participant	127˙512.00
8	INSTITUTE OF CANCER RESEARCH - ROYAL CANCER HOSPITAL  Organization address address: Old Brompton Road 123 city: LONDON postcode: SW7 3RP contact info Titolo: Mr. Nome: Yodry Cognome: Vasquez Email: send email Telefono: +44 207 153 5296 Fax: +44 207 370 5261	UK (LONDON)	participant	54˙178.00
9	Nome Ente NON disponibile  Organization address address: Route de Ganges 354 city: Montpellier postcode: 34000 contact info Titolo: Ms. Nome: Catherine Cognome: Vergely Email: send email Telefono: 33142115220 Fax: 33142115452	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)'