Midatech Pharma PLC IND Application for MTX110 Study in GBM Effective (4269V)
December 13 2021 - 4:42AM
UK Regulatory
TIDMMTPH
RNS Number : 4269V
Midatech Pharma PLC
13 December 2021
13 December 2021
Midatech Pharma PLC
("Midatech" or the "Company")
Investigational New Drug Application for Study of MTX110
in Recurrent Glioblastoma (GBM) Becomes Effective
Midatech Pharma PLC (AIM: MTPH; Nasdaq: MTP), a drug delivery
technology company focused on improving the bio-delivery and
biodistribution of medicines, is pleased to announce that its
Investigational New Drug (IND) application for a Phase 1 study of
MTX110 , a panobinostat complex to be administered by convection
enhanced delivery in patients with recurrent glioblastoma
multiforme (rGBM), has been cleared by the US FDA. Accordingly,
Midatech has initiated preparations for a study start in the first
half of 2022 .
Employing the Company's MidaSolve(TM) technology, MTX110
solubilises panobinostat, a histone deacetylase (HDAC) inhibitor
currently used in the treatment of multiple myeloma. In a liquid
formulation as MTX110, panobinostat can be delivered directly to a
patient's tumour under constant pressure via a catheter system
(Convection Enhanced Delivery, or "CED") thereby bypassing the
blood-brain barrier and allowing for high drug concentrations and
broader drug distribution in and around the tumour while
simultaneously minimising systemic toxicity and other side effects.
Panobinostat has demonstrated high potency against patient-derived
tumour cells in in vitro and in vivo models.
GBM is the most common and aggressive form of brain cancer in
adults, usually occurring in the white matter of the cerebrum.
Treatments include radiation, surgical resection and chemotherapy
although, in almost all cases, tumours recur. There are
approximately 2-3/100,000(1) diagnoses of GBM per annum. Survival
with standard of care treatment ranges from approximately 13 months
in unmethylated MGMT patients to approximately 30 months in highly
methylated MGMT patients(2) . Glioblastoma is an intractable brain
cancer.
The primary objective of the Phase I study will be to assess the
safety and tolerability of MTX110 in patients with rGBM. The study
is expected to include two clinical centres in the US and to begin
recruiting H1 2022.
Dmitry Zamoryakhin, Chief Scientific Officer of Midatech,
said:
"Our solubilising technology in combination with a CED system
offers the potential to deliver significantly higher doses of
panobinostat, a potent HDAC inhibitor, directly to the tumour.
Importantly, this targeting approach is designed to limit systemic
circulation of drug and therefore toxicity. This signal finding
Phase I study could point the way to a new treatment paradigm for
this intractable brain cancer."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
1. American Association of Neurosurgeons
2. Radke et al (2019). Predictive MGMT status in a homogeneous
cohort of IDH wildtype glioblastoma patients. Acta Neuropathologica
Communications 7:89 Online: https://doi. org/10.1186/s40478-019-0745-z
For more information, please contact: Midatech Pharma PLC
Stephen Stamp, CEO, CFO
Dmitry Zamoryakhin, CSO
Tel: +44 (0)29 2048 0180
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Joint
Broker)
Freddy Crossley, Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
Tel: +44 (0)20 7886 2500
Turner Pope Investments (TPI) Limited (Joint Broker)
Andrew Thacker / James Pope (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)
Maxwell Colbert
Tel: +1 (646) 653 7028
Email: mcolbert@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, including, but not
limited to, , any payments that may be received, the success
of the research collaboration in developing novel products,
the strategic review and formal sale process.
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,
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