Midatech receives Regulatory Approval for Clinically Testing Ultra-small Gold Nanoparticles
OXFORD, England--()--Midatech Ltd., a global leader in the design, development, synthesis and manufacture of nanomedicines, announced today it 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 AG.
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.
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About Midatech Ltd
Midatech Ltd, UK, is a world leader in the design, synthesis and manufacture of biocompatible nanoparticles. These nanoparticles can be used to create a wide variety of products with novel characteristics, functions and applications for a number of industry segments including life sciences, electronics and fine chemicals.
Founded in 2000, Midatech Ltd is a private company headquartered in Abingdon, Oxford, UK. In 2005 it registered its manufacturing facility – Midatech Biogune S.L. – in Bilbao, Spain, which became fully operational for cGMP standard design and manufacturing of API nanoparticles In March 2007. In 2008 Midatech Ltd further expanded with the opening of PharMida AG in Basel, Switzerland, which is responsible for clinical development of Midatech’s products. Midatech’s biocompatible nanoparticles possess a number of unique properties that make them ideal for diagnostic and therapeutic applications.
The nanoparticles are water soluble and can be designed to either diffuse freely in vivo, or to target specific cells. With a diameter of less than 5nm, unbound nanoparticles are freely excreted from the kidneys, reducing the likelihood of non-specific in vivo accumulation. Their size potentially enables drug delivery via different routes of administration, such as parental, transdermal, mucosal, intradermal transbuccal, sublingual or intranasal/inhalation. Their stability to enzymatic digestion may also permit oral therapy. Nanoparticles can be designed to be invisible to the host immune system with multiple ligands attached to a single nanoparticle allowing multivalent drug or multi-drug delivery on a single particle. In addition, as the nanoparticles self-assemble in a single step chemical process manufacturing is simple, safe, scaleable and low cost.
Midatech Ltd. has exclusive world-wide IP for the technology covering design, manufacture and application/use of nanoparticles in both diagnostic and therapeutic pharmaceutical areas as well as in other industries. It also has exclusive world-wide rights for technology relating to the synthesis and applications of self-assembling nanoparticles.
For further company information see www.midatechgroup.com