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Folate-Target Nanodevices To Activated Macrophages For Rheumatoid Arthritis

Objective

FOLSMART will bring to phase I clinical trials novel folate-based nanodevices (FBN) for the treatment of rheumatoid arthritis (RA). These nanodevices for folic acid (FA)-mediated targeting of activated macrophages showed improved clinical scores in a mouse model of RA when compared to methotrexate (MTX), first-line drug therapy for the treatment of RA. In this way, FBN will be benchmarked against this drug. MTX has significant associated toxicity and second-line biological therapies pose a great economic burden to hospital/public health systems. In parallel, nanodevices encapsulating Sulfasalazine (SSZ), will be tested. SSZ is a second line indication for the treatment of RA, unresponsive to MTX or MTX–intolerant patients. Furthermore, FOLSMART proposes the optimization of mechanisms for the release of the drugs, through pH and temperature-sensitive nanodevices. Exploitation and business plans will be elaborated. In parallel, the initial economic evaluation of all proposed treatments will be performed to validate these claims.

Specific technological objectives of FOLSMART will be:

Good Manufacturing Practice (GMP) production of the FBN based therapies which have been positively bench-marked in the previous FP7 European project NANOFOL in comparison with the use of MTX in a RA mouse model:
-Liposomal MTX and SSZ with FA-“neck domain” peptide as targeting agent
-Nanoparticles from HSA-FA/MTX conjugates and SSZ
-Optimization of mechanisms of drug release and application to other fields

Pre-clinical development on RA models:
-Toxicology and pharmacokinetics, to determine tolerability and efficacy benefit in two animal models rat and dog, under Good Laboratory Practice (GLP) standards
-Genotoxicity and Carcinogenicity

Preparation for Phase I clinical trial of the best therapies bench marketed against MTX:
-Nanodevices with MTX and SSZ will offer improved tolerance and greater efficacy meaning that patients who do not do well on MTX will have cost-effective alternatives

Call for proposal

H2020-NMP-PILOTS-2015
See other projects for this call

Coordinator

ASSOCIACAO UNIVERSIDADE EMPRESA PARA DESENVOLVIMENTO TECMINHO
Address
Campus De Azurem Universidade Do Minho
4800 058 Guimaraes
Portugal
Activity type
Other
EU contribution
€ 1 130 037,70

Participants (10)

SYNOVO GMBH
Germany
EU contribution
€ 296 087,50
Address
Paul Ehrlich Str 15
72076 Tuebingen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITAET FUER BODENKULTUR WIEN
Austria
EU contribution
€ 395 643,75
Address
Gregor Mendel Strasse 33
1180 Wien
Activity type
Higher or Secondary Education Establishments
BLUECLINICAL - INVESTIGACAO E DESENVOLVIMENTO EM SAUDE LDA
Portugal
EU contribution
€ 442 853,30
Address
Avenida Villagarcia De Arosa 1919 1
4460 439 Motosinhos
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 400 597,50
Address
Spitalgasse 23
1090 Wien
Activity type
Higher or Secondary Education Establishments
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 484 487,50
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
INSTITUTO DE BIOLOGIA MOLECULAR E CELULAR-IBMC
Portugal
EU contribution
€ 432 911,25
Address
Rua Alfredo Allen 208
4200 135 Porto
Activity type
Research Organisations
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 8 875
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
APTUIT (VERONA) SRL
Italy
EU contribution
€ 653 240
Address
Via Alessandro Fleming 4
37135 Verona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BLUEPHARMA - INDUSTRIA FARMACEUTICASA
Portugal
EU contribution
€ 343 758,55
Address
Sao Martinho Do Bispo
3045 016 Coimbra
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
SOLFARCOS - SOLUÇÕES FARMACÊUTICAS E COSMÉTICAS LDA
Portugal
EU contribution
€ 405 341,70
Address
Rua Quinta Dos Orfaos Bloco A Loja 6
4710-453 Braga
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)