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Folsmart - Folate-Target Nanodevices to Activated Macrophages for Rheumatoid Arthritis

Project Leader
Gübitz Georg, BOKU Project Leader
Duration:
01.01.2016-31.10.2020
Programme:
Horizon 2020 - Industrial Leadership - Innovation Action (IA)
Type of Research
Applied Research
Project partners
Blueclinical, Ltd, Av. Villagarcia de Arosa, 1919 - 1º, 4460-439 Matosinhos, Portugal.
Contact person: Dr. Luis Almeida;
Function of the Project Partner: Partner
GABO:mi Gesellschaft für Ablauforganisation :milliarium mbH & Co. KG, Oskar-von-Miller-Ring 29, 80333 München, Germany.
Contact person: DI Dieter Schuster;
Function of the Project Partner: Partner
Institut national de la santé et de la recherche médicale, 101, rue de Tolbiac, 75654 Paris Cedex 13, France.
Contact person: Dr. Gilles Renault;
Function of the Project Partner: Partner
Institute for Molecular and Cell Biology, Rua do Campo Alegre 823, 4150-180 Porto, Portugal.
Contact person: Dr. Alexandre Carmo;
Function of the Project Partner: Partner
SYNOVO GmbH, Paul Ehrlich Str. 15, 72076 Tübingen, Germany.
Contact person: Dr. Michael Burnet;
Function of the Project Partner: Partner
TecMinho - Associação Universidade-Empresa para o Desenvolvimento, Campus de Azurém da Universidade do Minho , 4800-058 Guimarães, Portugal.
Contact person: Prof. Artur Cavaco-Paulo;
Function of the Project Partner: Koordinator
Universitätsklinik für Frauenheilkunde, Austria.
Contact person: Prof. Hannes Stockinger;
Function of the Project Partner: Partner
Staff
Quartinello Felice, Project Staff
Tallian-Langer Claudia, Project Staff (bis 31.12.2019)
BOKU Research Units
Institute for Environmental Biotechnology
Funded by
Commission of the European Communities, Rue de la Loi, Brussels, European Union
Abstract
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
Keywords
Medical biotechnology;
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