Full Press Release Details
("Midatech" or the "Company")
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 an update on its
key MTX110 programme.
MTX110 is designed for the treatment of childhood brain
cancers such as Diffuse Intrinsic Pontine Glioma ("DIPG"), an ultra-rare highly aggressive and inoperable tumour located
in the brain stem, that is universally fatal with an average life expectancy of 7 to 9 months. Midatech is also evaluating MXT110
for the treatment of Glioblastoma Multiforme ("GBM"), which is a fast-growing form of brain cancer in adults.
The initial MTX110 study (PNOCO15) in DIPG patients,
began in May 2018 and is a combined Phase I (safety) and Phase II (efficacy) programme. Phase I is a dose escalating component
originally designed with five dose levels; however, since MTX110 has been well tolerated in the patients treated to date, a further
two higher dose levels have been added to the study. This Phase I component is scheduled to complete in Q3 2019.
Based on the Phase I progress to date, the Recommended
Phase II Dose ("RP2D") has preliminary been set at the upper dosage level achieved in this Phase I component. A further
small cohort of three patients will now be treated to complete the "3+3 design", the traditional standard dose escalation
schedule in the development of cancer therapeutics, and to confirm this RP2D dose, bringing the total number of patients treated
at the final RP2D to five. We expect these patients will join the Phase II efficacy component, which is scheduled to start during
Q3/4 2019, following confirmation from the US Food and Drug Administration.
Dr Sabine Mueller, Principal Investigator for the
study said: "Midatech's MTX110 has shown promise as one of the most potent compounds against DIPG brain tumour
cells in laboratory experiments. In this first in human study of MTX110 we are encouraged by the excellent safety profile so far
and look forward to completing the safety evaluation and commencing the efficacy assessment of the drug later this year."
Midatech's Chief Executive Officer, Dr Craig Cook,
said: "We are delighted to be able to give this update on how the MTX110 programme is progressing. The patients
have reacted very well from a safety perspective to MTX110 to date and we hope to advance to the Phase II component later this
year and further evaluate MTX110 as a very promising therapy for DIPG, for which there are no effective treatments. We look forward
to providing further updates as the development programme progresses."
This announcement contains inside information for the
purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For more information, please contact:
Tel: +44 (0)1235 888300
Panmure Gordon (UK) Limited
(Nominated Adviser and Broker)
Freddy Crossley, Emma Earl (Corporate
James Stearns (Corporate Broking)
Tel: +44 (0)20 7886 2500
IFC Advisory Limited (Financial
PR and UK Investor Relations)
Tim Metcalfe / Graham Herring
Tel: +44 (0)20 3934 6630
Westwicke Partners (US Investor Relations)
Tel: +1 339 970 2843
Email: chris.brinzey@westwicke.com
About Midatech Pharma PLC
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 MTX110, 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.