FIGHT-HLH

First Targeted Therapy to FIGHT Hemophagocytic Lymphohistiocytosis (HLH): A novel approach to HLH

Coordinatore	NOVIMMUNE SA    more  Organization address address: CHEMIN DES AULX 14 city: PLAN LES OUATES GENEVE postcode: 1228 contact info Titolo: Ms. Nome: Nathalie Cognome: Muller Email: send email Telefono: +41 22 839 71 41 Fax: +41 22 839 71 43
Nazionalità Coordinatore	Switzerland [CH]
Totale costo	11˙241˙261 €
EC contributo	5˙946˙261 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2012-INNOVATION-1
Funding Scheme	CP-FP
Anno di inizio	2012
Periodo (anno-mese-giorno)	2012-07-01   -   2016-05-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	NOVIMMUNE SA  Organization address address: CHEMIN DES AULX 14 city: PLAN LES OUATES GENEVE postcode: 1228 contact info Titolo: Ms. Nome: Nathalie Cognome: Muller Email: send email Telefono: +41 22 839 71 41 Fax: +41 22 839 71 43	CH (PLAN LES OUATES GENEVE)	coordinator	4˙506˙535.00
2	SINTESI RESEARCH SRL  Organization address address: VIA RIPAMONTI GIUSEPPE 89 city: MILANO postcode: 20141 contact info Titolo: Dr. Nome: Paolo Cognome: De Simoni Email: send email Telefono: 3902566651 Fax: 390297000000	IT (MILANO)	participant	476˙026.80
3	AZIENDA OSPEDALIERO-UNIVERSITARIA ANNA MEYER  Organization address address: VIALE PIERACCINI 24 city: FIRENZE postcode: 50139 contact info Titolo: Dr. Nome: Matteo Cognome: Sammartino Email: send email Telefono: +39 055 5662301 Fax: +39 055 5662379	IT (FIRENZE)	participant	298˙800.00
4	OSPEDALE PEDIATRICO BAMBINO GESU  Organization address address: PIAZZA SAN ONOFRIO 4 city: ROMA postcode: 165 contact info Titolo: Dr. Nome: Sonya Jane Cognome: Martin Email: send email Telefono: +39 06 6859 2497 Fax: +39 06 6859 2101	IT (ROMA)	participant	266˙890.00
5	LONZA BIOLOGICS PLC  Organization address address: BATH ROAD 228 city: LONDON postcode: SL1 4DX contact info Titolo: Mr. Nome: Gerry Cognome: Kennedy Email: send email Telefono: +44 1753 716860	UK (LONDON)	participant	199˙200.00
6	PATERGRUS BVBA  Organization address address: NIEUWE DREEF 2 A city: AALTER postcode: 9880 contact info Titolo: Dr. Nome: Marc Cognome: Van De Craen Email: send email Telefono: +32 493 49 66 62	BE (AALTER)	participant	198˙810.00

Mappa

 Word cloud

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 Obiettivo del progetto (Objective)

'Hemophagocytic lymphohistiocytosis (HLH) is a rare, devastating disease characterized by uncontrolled immune response that primarily affects young infants and children. HLH is usually fatal if untreated. Even when treated, the overall survival rate is still as low as 60-70%. No drug has been formally developed for the treatment of this disease and current treatment methods require the use of drugs which have not formally been developed for this indication which have an unfavourable safety profile. The cytokine interferon-gamma (IFNγ) was shown to play a key pathological role in the disease. It has been demonstrated that neutralization of IFNγ with a monoclonal antibody (mAb) reverts the disease and rescues animals from death in murine models of primary HLH. In patients, evidence points towards a correlation between levels of IFNγ and disease activity. In order to target IFNγ in patients with HLH, NovImmune generated and characterized a fully human mAb, NI-0501, that neutralizes the biological activity of human IFNγ. This consortium proposes an adaptive clinical trial with a pilot and a pivotal phase to provide the necessary data for Market Access Authorization for NI-0501 in HLH. The pilot phase will enroll only patients well-known to have a primary form of HLH and who relapsed after having responded to an initial treatment while the pivotal phase will open the recruitment to newly diagnosed HLH patients. The transition between the pilot and the pivotal phase will be governed by strict pre-defined transition rules and will only occur if a favorable benefit-risk profile has been demonstrated. During the course of the pilot phase the consortium will attempt to generate the necessary information to justify the inclusion in the pivotal phase of a broad range of HLH patient (secondary forms of the disease), for which the pivotal role of IFNγ will have been demonstrated thanks to the research activities of members of the consortium.'

Introduzione (Teaser)

European scientists are in the process of developing new therapy for a rare haematological disorder.