Midatech Pharma PLC Fast Track Designation for MTX110 Development (5877N)
June 01 2022 - 7:23AM
UK Regulatory
TIDMMTPH
RNS Number : 5877N
Midatech Pharma PLC
01 June 2022
1 June 2022
Midatech Pharma PLC
("Midatech" or the "Company")
Fast Track Designation Granted to MTX110 Development for the
Treatment of Recurrent Glioblastoma
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D
biotechnology company focused on improving the bio-delivery and
biodistribution of medicines , is pleased to announce that upon
submitting an application to the U.S. Food and Drug Administration
("FDA"), its development programme of MTX110 for the treatment of
recurrent glioblastoma ("rGBM") has been granted Fast Track
designation by the agency.
Fast Track is a process designed to facilitate the development
and expedite the review of treatments for serious conditions and
that potentially address unmet medical needs. Drugs that are
granted this designation are given the opportunity for more
frequent interactions with the FDA, as well as potential pathways
for expedited approval.
Commenting, Dmitry Zamoryakhin, CSO of Midatech, said: "rGBM is
a devastating cancer marked by short survival rate and universal
recurrence. Receiving Fast Track designation for MTX110 is an
important milestone for the development of the drug as it
demonstrates the need for novel and effective treatment options for
this currently universally fatal disease. MTX110, our water-soluble
formulation of Panobinostat, will soon start recruitment into a
Company-sponsored Phase I study in patients with recurrent
GBM."
This announcement contains inside information for the purposes
of Article 7 of the Market Abuse Regulation (EU) 596/2014, as it
forms part of UK domestic law by virtue of the European Union
(Withdrawal) Act 2018 (as amended).
About MTX110
MTX110 is a water-soluble form of panobinostat free base,
achieved through complexation with
hydroxypropyl-<BETA>-cyclodextrin (HPBCD), that enables
convection-enhanced delivery (CED) at potentially chemotherapeutic
doses directly to the site of the tumour. Panobinostat is a
hydroxamic acid and acts as a non-selective histone deacetylase
inhibitor (pan-HDAC inhibitor). The currently available oral
formulation of panobinostat lactate (Farydak(R)) is not suitable
for treatment of brain cancers owing to poor blood-brain barrier
penetration and inadequate brain drug concentrations. Based on
favourable translational science data, MTX110 is being evaluated
clinically as a treatment for DIPG (NCT03566199, NCT04264143) and
recurrent medulloblastoma (NCT04315064), and preclinically for
treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is
delivered directly into and around the patient's tumour via a
catheter system (e.g. CED or fourth ventricle infusions) to bypass
the blood-brain barrier. This technique exposes the tumour to very
high drug concentrations while simultaneously minimising systemic
drug levels and the potential for toxicity and other side effects.
Panobinostat has demonstrated high potency against DIPG tumour
cells in in vitro and in vivo models, and in a key study it was the
most promising of 83 anticancer agents tested in 14 patient-derived
DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6),
555-559).
For more information, please contact:
Midatech Pharma PLC
Dmitry Zamoryakhin, CSO
Tel: +44 (0)29 20480 180
www.midatechpharma.com
Strand Hanson Limited (Nominated and Financial Adviser)
James Dance / Matthew Chandler / Rob Patrick
Tel: +44 (0)20 7409 3494
Turner Pope Investments (TPI) Limited (Joint Broker)
Andrew Thacker (Corporate Broking)
Tel: +44 (0)20 3657 0050
IFC Advisory Limited (Financial PR and UK Investor Relations)
Tim Metcalfe / Graham Herring
Tel: +44 (0)20 3934 6630
Email: midatech@investor-focus.co.uk
Edison Group (US Investor Relations)
Alyssa Factor
Tel: +1 (860) 573 9637
Email: afactor@edisongroup.com
About Midatech Pharma PLC
Midatech Pharma PLC (dual listed on LSE AIM: MTPH; and NASDAQ:
MTP) is a drug delivery technology company focused on improving
the bio-delivery and bio-distribution of medicines . The Company
combines approved and development medications with its proprietary
and innovative drug delivery technologies to provide compelling
products that have the potential to powerfully impact the lives
of patients.
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:
* Q-Sphera(TM) platform: a disruptive micro-technology
used for sustained release to prolong and control the
release of therapeutics over an extended period of
time (from weeks to months).
* MidaSolve(TM) platform: an innovative nanotechnology
used to dissolve insoluble drugs so that they can be
administered in liquid form directly and locally into
tumours.
* MidaCore(TM) platform: a leading-edge nanotechnology
used for targeting medications to sites of disease.
The platform nature of the technologies offers the potential to
develop multiple drug assets rather than being reliant on a limited
number of programmes. Midatech's technologies are supported by
36 patent families including 120 granted patents and an additional
70 patent applications. Midatech's headquarters and R&D facility
is in Cardiff, UK. For more information please visit www.midatechpharma.com
Forward-Looking Statements
Certain statements in this press release may constitute
"forward-looking statements" within the meaning of legislation in
the United Kingdom and/or United States Private Securities
Litigation Reform Act. All statements contained in this press
release that do not relate to matters of historical fact should be
considered forward-looking statements.
Reference should be made to those documents that Midatech shall
file from time to time or announcements that may be made by
Midatech 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 Midatech 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,
Midatech does not undertake any obligation to publicly update or
revise any forward-looking statements because of new information,
future events or otherwise arising.
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