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Content archived on 2024-06-18

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)

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

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Call for proposal

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

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

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

Coordinator

INSTITUT GUSTAVE ROUSSY
EU contribution
€ 2 602 030,00
Address
Rue Camille Desmoulins 39
94805 Villejuif
France

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Region
Ile-de-France Ile-de-France Val-de-Marne
Activity type
Research Organisations
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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Participants (8)

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