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Preclinical toxicity and pharmacokinetics of a new orally bioavailable flubendazole formulation and the impact for clinical trials and risk/benefit to patients.
PLoS Negl Trop Dis
January 2019
Nonclinical Safety, Janssen Research & Development, A Division of Janssen Pharmaceutica NV, Beerse, Belgium.
Background: Flubendazole, originally developed to treat infections with intestinal nematodes, has been shown to be efficacious in animal models of filarial infections. For treatment of filarial nematodes, systemic exposure is needed. For this purpose, an orally bioavailable amorphous solid dispersion (ASD) formulation of flubendazole was developed.
View Article and Find Full Text PDFGenotoxicity of flubendazole and its metabolites in vitro and the impact of a new formulation on in vivo aneugenicity.
Mutagenesis
May 2016
Drugs for Neglected Diseases Initiative, Chemin Louis-Dunant 15, 1202 Genève, Switzerland and.
The anti-parasitic benzimidazole flubendazole has been used for many years to treat intestinal infections in humans and animals. Previous genotoxicity studies have shown that the compound is not a bacterial mutagen and a bone marrow micronucleus test, using a formulation that limited systemic absorption, was negative. The purpose of this study is to explore the genotoxicity of flubendazole and its main metabolites in in vitro micronucleus studies and to test a new oral formulation that improves systemic absorption in an in vivo micronucleus test.
View Article and Find Full Text PDFGenotoxic mixtures and dissimilar action: concepts for prediction and assessment.
Arch Toxicol
March 2014
Institute for the Environment, Brunel University, Kingston Lane, Uxbridge, Middlesex, UB8 3PH, UK,
Combinations of genotoxic agents have frequently been assessed without clear assumptions regarding their expected (additive) mixture effects, often leading to claims of synergisms that might in fact be compatible with additivity. We have shown earlier that the combined effects of chemicals, which induce micronuclei (MN) in the cytokinesis-block micronucleus assay in Chinese hamster ovary-K1 cells by a similar mechanism, were additive according to the concept of concentration addition (CA). Here, we extended these studies and investigated for the first time whether valid additivity expectations can be formulated for MN-inducing chemicals that operate through a variety of mechanisms, including aneugens and clastogens (DNA cross-linkers, topoisomerase II inhibitors, minor groove binders).
View Article and Find Full Text PDFUMF-078: A modified flubendazole with potent macrofilaricidal activity against Onchocerca ochengi in African cattle.
Parasit Vectors
June 2008
Veterinary Parasitology, Liverpool School of Tropical Medicine/Faculty of Veterinary Science, University of Liverpool, Pembroke Place, Liverpool, UK.
Background: Human onchocerciasis or river blindness, caused by the filarial nematode Onchocerca volvulus, is currently controlled using the microfilaricidal drug, ivermectin. However, ivermectin does not kill adult O. volvulus, and in areas with less than 65% ivermectin coverage of the population, there is no effect on transmission.
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