Folsmart - Folate-Target Nanodevices to Activated Macrophages for Rheumatoid Arthritis
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
Publikationen
Project staff
Georg Gübitz
Univ.Prof. Dipl.-Ing. Dr.techn. Georg Gübitz
guebitz@boku.ac.at
Tel: +43 1 47654-97001, 97402
BOKU Project Leader
01.01.2016 - 31.10.2020
Felice Quartinello
Dr.nat.techn. Felice Quartinello MSc.
felice.quartinello@boku.ac.at
Tel: +43 1 47654-97488
Project Staff
01.01.2016 - 31.10.2020
BOKU partners
External partners
Institut national de la santé et de la recherche médicale
Dr. Gilles Renault
partner
GABO:mi Gesellschaft für Ablauforganisation :milliarium mbH & Co. KG
DI Dieter Schuster
partner
Blueclinical, Ltd
Dr. Luis Almeida
partner
SYNOVO GmbH
Dr. Michael Burnet
partner
Institute for Molecular and Cell Biology
Dr. Alexandre Carmo
partner
TecMinho - Associação Universidade-Empresa para o Desenvolvimento
Prof. Artur Cavaco-Paulo
coordinator
Universitätsklinik für Frauenheilkunde
Prof. Hannes Stockinger
partner