Midatech (AIM: MTPH; Nasdaq: MTP), the international specialty pharmaceutical company focused on commercialising and developing products in oncology, immunology and other therapeutic areas, today announces that its first in human Phase I study of an innovative vaccine (MTX102) using its gold nanoparticle (GNP) technology in type 1 diabetes has commenced. The results from the study are expected in 2017. The nano-vaccine approach also has potential applicability in oncology.
The MTX102 vaccine uses Midatech's primary platform GNP technology. GNPs are inert and chemically bound to small antigens which generate a tolerogenic response when injected into the skin, turning down the immune response against the insulin producing cells which cause type 1 diabetes. This is the first investigational product of its type to be used in humans.
The Phase I study of eight subjects aged 16-40 years with type 1 diabetes and residual endogenous insulin production aims to examine the general safety and tolerability of treatment. Secondary objectives are to study the feasibility of delivering GNP via microneedles and the scale and nature of immune responses generated in the body. The trial, conducted at two centres (Cardiff, UK and Linköping, Sweden), is the culmination of a four-year European Commission-supported program EE-ASI into researching beta cell preservation using Antigen Specific Immunotherapy (ASI) via GNP technology (www.ee-asi.eu).
Commenting on the announcement, Dr Jim Phillips, CEO of Midatech, said: “I am pleased to be able to announce the start of this important Phase I study which uses our GNP technology in an immunotherapy. We are hopeful that this trial will demonstrate the broad applicability of our technology and is exciting for the future of our R&D pipeline. We are pleased to be performing this study with support by a European Commission grant, and look forward to updating the market with results in 2017.”