03K

Oral Off-patent Oncology Drugs for Kids

 Coordinatore 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

 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


 Word cloud

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

pharmacological    drug    treatment    nods    cancer    safety    clinical    children    reg       paediatric    emea    cyclophosphamide    liquid    formulations    temozolomide    drugs    curative    oral   

 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)'

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