Midatech receives Regulatory Approval for Clinically Testing Ultra-small Gold Nanoparticles
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The trial is designed to 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, Switzerland and results of the trial are expected during Q1 2012.
Midatech has developed ultra-small gold nanoparticles (GNP, < 2 nm) that 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 like 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,” Thomas Rademacher, CEO and Chairman of Midatech Group said, adding: “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 Spanish-based IMP Licenced manufacturing subsidiary, Midatech Biogune SA, will be able to provide clinical-grade material for these studies.
Midatech’s aim is to provide innovative solutions for the delivery and stabilisation of bioactive peptides for therapeutic indications and peptide antigens for prophylactic and therapeutic vaccines.
Midatech has a collaboration with MonoSol Rx, Warren, NJ (USA) to develop products by combining its proprietary gold-nanoparticle technology with MonoSol's PharmFilm® drug delivery technology and a Joint Venture with Immunotope in Doylestown, PA (USA) to develop nanoparticle based immunotherapeutic cancer vaccines for the delivery of peptide antigens.
