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Oral Off-patent Oncology Drugs for Kids

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)

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /medical and health sciences/clinical medicine/oncology

Call for proposal

FP7-HEALTH-2007-B
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

INSTITUT GUSTAVE ROUSSY
Address
Rue Camille Desmoulins 39
94805 Villejuif
France
Activity type
Research Organisations
EU contribution
€ 2 602 030
Administrative Contact
Arnauld Forest (Mr.)

Participants (8)

UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
EU contribution
€ 376 201
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nicola Place (Ms.)
UNIVERSITA CATTOLICA DEL SACRO CUORE
Italy
EU contribution
€ 149 272
Address
Largo Gemelli 1
20123 Milano
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Franco Mariotti (Dr.)
THE INSTITUTE OF CANCER RESEARCH: ROYAL CANCER HOSPITAL
United Kingdom
EU contribution
€ 54 178
Address
Old Brompton Road 123
SW7 3RP London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Yodry Vasquez (Mr.)
ORALANCE PHARMA S.A.
France
EU contribution
€ 840 730
Address
Bio Step Bâtiment C, Rue Pierre Et Marie Curie
31681 Labège
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Karim Ioualalen (Mr.)
Keocyt SAS
France
EU contribution
€ 702 110
Address
Rue Chauvelot 29
92240 Malakoff
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Christophe Michel Pasik (Dr.)
UNIVERSITY OF LEICESTER
United Kingdom
EU contribution
€ 127 512
Address
University Road
LE1 7RH Leicester
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marie Singer (Ms.)
Negositek
France
EU contribution
€ 324 210
Address
Rue De La Salle L Evêque 12
34000 Montpellier
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olivier Saslawski (Dr.)
Union Nationale des Associations de Parents d’Enfants atteints de Cancer ou de Leucémie
France
EU contribution
€ 51 760
Address
Route De Ganges 354
34000 Montpellier
Activity type
Research Organisations
Administrative Contact
Catherine Vergely (Ms.)