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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), a 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 poses 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 propose the optimization of mechanisms for the release of the drugs, through pH and temperature sensitive nanodevices. An exploitation and business plans will be elaborated. In parallel, 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

Phase I clinical trials 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

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmacokinetics
  • /social sciences/economics and business
  • /medical and health sciences/basic medicine/toxicology

Call for proposal

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

Funding Scheme

RIA - Research and Innovation action

Coordinator

ASSOCIACAO UNIVERSIDADE EMPRESA PARA DESENVOLVIMENTO TECMINHO
Address
Campus De Azurem Universidade Do Minho
4800 058 Guimaraes
Portugal
Activity type
Other
EU contribution
€ 1 142 037,70

Participants (10)

SYNOVO GMBH
Germany
EU contribution
€ 300 000
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
€ 399 556,25
Address
Gregor Mendel Strasse 33
1180 Wien
Activity type
Higher or Secondary Education Establishments
BLUECLINICAL - INVESTIGACAO E DESENVOLVIMENTO EM SAUDE LDA
Portugal
EU contribution
€ 629 845
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
€ 404 510
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
€ 488 400
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
INSTITUTO DE BIOLOGIA MOLECULAR E CELULAR-IBMC
Portugal
EU contribution
€ 436 823,75
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
€ 544 440
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
€ 327 671,05
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
€ 311 675
Address
Centro De Engenharia Biologica - Escola De Engenha Versidade Do Minho Campus De Gualtar
4710 057 Braga
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)