Midatech Announces Safety Results from First in Human Study for Injectable MidaCore® Gold NanoParticle Diabetes Vaccine Programme – MTX102
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients is pleased to announce positive results from a first-in-human study of its MTX102 immuno-tolerising vaccine product candidate in diabetes.
The focus of this Phase I study is to assess the safety of MTX102. Five recently diagnosed Type I diabetes patients, all meeting strict genetic parameters, were recruited onto the study and received the study drug. MTX102 was well tolerated, with asymptomatic local injection site reactions being the only drug-related finding, and no serious adverse events were reported.
This is an important study of systemic injectable administration of Midatech’s gold nanoparticle technology, MidaCore®. It provides promising safety validation of the MidaCore® technology as a platform for the development of medications for use in humans.
Colin Dayan, Principal Investigator, said “This EU project brings together a consortium comprising eight complementary partners, including two small and medium enterprises, one technology transfer company and five academic laboratories, from four EU states (UK, France, the Netherlands and Sweden) and Israel. We are pleased to have completed the initial project, based on Midatech’s gold nanoparticle technology, to evaluate a vaccine approach for the treatment of Type 1 diabetes. The study now enters a follow-up stage, at the end of which we will review the data and programme, together with the EU consortium partners.
Craig Cook, CEO of Midatech Pharma PLC, commented: “This EU funded programme is an invaluable project to further develop, understand and evaluate Midatech’s gold nanoparticle technology, MidaCore®. This is the first human study to assess the safety of MidaCore® when injected into patients, and we are pleased that the data generated to date validates the technology as a potentially innovative treatment platform for medical applications.”
The aim of the study to assess safety has been achieved and no further patients will be recruited. All patients on the trial will now enter the follow-up phase which will conclude around Q1 2020.
MTX102 is based on Midatech’s MidaCore® technology platform of ultra-small gold nanoparticle drug conjugates. MidaCore® is being developed as an immunotherapeutic as well as a chemotherapeutic platform. In vaccines, it represents an innovative approach that takes advantage of the multifunctional properties of gold nanoparticles to combine immunogenic peptides and tolerising agents and deliver them more efficiently to immune cells to dampen down autoimmune responses in diseases such as diabetes.
Midatech is part of a consortium of academic institutions and industry partners investigating the potential of MTX102 as a vaccine to prevent or limit the damage that occurs when the body attacks its own insulin-producing cells in the pancreas. This project is funded by the European Union up to the completion of Phase I study.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
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