Full Press Release Details
("Midatech" or the "Company")
Midatech Announces Positive Safety Results
from First in Human Study for Injectable MidaCore Gold Nano Particle 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
This announcement contains inside information
for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For more information, please contact:
(UK) Limited (Nominated Adviser and Broker)
Emma Earl (Corporate Finance)
Limited (Financial PR and UK Investor Relations)
Graham Herring / Heather Armstrong
Westwicke Partners (US Investor Relations)
Tel: +1 339 970 2843
Email: chris.brinzey@westwicke.com
Midatech Pharma PLC (dual listed on LSE
AIM: MTPH; and NASDAQ: MTP) is an R&D company focused on Making Medicines Better' by improving delivery of drugs
in the body. The Company combines existing medications with its proprietary and innovative drug delivery technologies to
provide compelling oncology and rare disease products that have the potential to powerfully impact the lives of patients undergoing
treatment for life threatening diseases.
The Company has developed three in house
technology platforms, each with its own unique mechanism to improve delivery of medications to sites of disease. All of the Company's
technologies have successfully entered human use in the clinic, providing important validation of the potential for each platform:
By improving biodelivery and biodistribution
of approved existing molecules, Midatech's unique R&D makes medicine better, lowers technical risks, accelerates regulatory
approval and route to market, and provides newly patentable products. The platform nature of the technologies allows the potential
for multiple drug assets rather than being reliant on a single or limited programmes.
Midatech's headquarters and R&D facility
is in Cardiff, UK, and manufacturing operation in Bilbao, Spain. For more information please visit www.midatechpharma.com
Forward-Looking Statements
Certain statements in this announcement
may constitute "forward-looking statements" within the meaning of legislation in the United Kingdom and/or United States.
Such forward-looking statements include, but are not limited to, statements expressed or implied regarding our plans, goals, and
milestones, our ability to successfully test, manufacture, produce or commercialise products for conditions using our drug delivery
platforms, the ability for products in development, including MTX102, to achieve positive clinical results, the ability to meet
or achieve timelines associated with pre-clinical studies, clinical trials or regulatory submissions and the associated costs of
such studies, trials or submissions, and other economic, business and/or competitive factors. The risks included are not exhaustive.
Any forward-looking statements are based on currently available competitive, financial and economic data together with management's
views and assumptions regarding future events and business performance as of the time the statements are made and are subject to
risks and uncertainties. We wish to caution you that there are some known and unknown factors that could cause actual results to
differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements.
Reference should be made to those documents
that we shall file from time to time or announcements that may be made by the Company in accordance with the London Stock Exchange
AIM Rules for Companies ("AIM Rules"), the Disclosure and Transparency Rules ("DTRs") and the rules and regulations
promulgated by the US Securities and Exchange Commission, which contains and identifies other important factors that could cause
actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking
statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning
the Company are expressly qualified in their entirety by the cautionary statements above. Except as may be required under the AIM
Rules or the DTRs or by relevant law in the United Kingdom or the United States, we do not undertake any obligation to publicly
update or revise any forward-looking statements because of new information, future events or otherwise arising.