Trial will assess safety profile of insulin-coated gold nanoparticles applied in transbuccal film
Midatech, a UK-based developer and manufacturer of nanomedicines, has received Swissmedic approval to start the first-in-human clinical trial with insulin-coated gold nanoparticles, which will be coordinated through its Swiss subsidiary PharMida, based in Basel.
The trial will assess the safety profile of insulin-coated gold nanoparticles when applied in transbuccal film to healthy volunteers. The study will be performed in a clinical research unit near Basel, with results expected during Q1 2012.
Midatech has developed ultra-small gold nanoparticles (GNP, <2nm), which act as artificial atoms that are covalently surface-passivated with a mixed carbohydrate/organic layer (corona). The corona is designed to non-covalently bind and stabilise multiple copies of bioactive peptides such as insulin and glucagon-like peptide-1 (GLP-1). Extensive pre-clinical studies with GNP and peptide-GNP have demonstrated favourable PK properties and a clean safety profile in studies with single and multiple dosing by oral, intravenous, subcutaneous and transbuccal route in various animal species.
‘This is the first time that solid core nanoparticles of this size and nature will enter human clinical trials,’ said Thomas Rademacher, chief executive and chairman of Midatech Group.
‘Based on the excellent preclinical and toxicology results obtained for Midatech’s gold nanoparticles in multiple animal models, we are pleased to move to the next stage of development and test the safety of our nanoparticles in human clinical trials. We are also pleased that our Spain-based IMP licensed manufacturing subsidiary, Midatech Biogune, will be able to provide clinical-grade material for these studies.
Midatech has a collaboration with MonoSol Rx to develop products by combining its proprietary gold-nanoparticle technology with MonoSol's PharmFilm drug delivery technology and a joint venture with Immunotope to develop nanoparticle based immunotherapeutic cancer vaccines for the delivery of peptide antigens.