Midatech Group has declared that Swissmedic approval has been granted to it to begin the first-in-human clinical study with insulin-coated gold nanoparticles in partnership with PharMida, its subsidiary based in Switzerland.
The clinical study is designed to validate the toxicity of insulin-coated gold nanoparticles during its delivery through transbuccal film into healthy volunteers. The trial will be conducted in a clinical study unit located near Basel, Switzerland, and its findings are anticipated during the first quarter of 2012.
Midatech intends to develop advanced solutions for the stabilization and delivery of bioactive peptides for the indication of therapeutics and peptide antigens for both therapeutic and prophylactic vaccines. Through its partnership with MonoSol, the company intends to manufacture products using its in-house gold-nanoparticle technology and MonoSol's PharmFilm drug delivery technology. The company’s joint venture with Doylestown, Pennsylvania-based Immunotope plans to manufacture immunotherapeutic cancer vaccines based on nanoparticles for peptide antigen delivery.
Midatech has created gold nanoparticles having a size below 2 nm, which function as synthetic atoms that are covalently surface-passivated using a mixture of carbohydrate/organic layer (corona). The corona is capable of stabilizing and non-covalently binding numerous replicas of bioactive peptides such as insulin-like and glucagon-like peptide-1 (GLP-1). During preclinical trials, gold nanoparticles and peptide-gold nanoparticles have shown encouraging PK properties and a complete safety profile in trials with single and manifold dosage through transbuccal, subcutaneous, intravenous and oral method in numerous animal species.
The Chairman and Chief Executive Officer at Midatech Group, Thomas Rademacher stated that the company is happy to shift to the next phase of development and assess the safety of its nanoparticles in the first-in-human clinical studies based on the favorable toxicology and preclinical findings on its gold nanoparticles when applied in several animal models. The company is also happy to announce that Midatech Biogune, its IMP licensed production subsidiary based in Spain, will supply clinical-grade materials for these trials, he added.