TIDMMTPH
RNS Number : 4768M
Midatech Pharma PLC
12 January 2023
12 January 2023
Midatech Pharma PLC
("Midatech" or the "Company")
Planned Dose Escalation in Phase 1 Study of MTX-110 (MAGIC-G1
Study) in Patients with 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
following completion of one month of treatment with MTX-110 in the
first patient, its Phase I study of MTX-110 in recurrent
glioblastoma ("rGB") (NCT 05324501) will continue with a planned
dose escalation following a positive recommendation from the
study's Data Safety Monitoring Board ("DSMB").
The Phase I study, the MAGIC-G1 study, is an open-label, dose
escalation study designed to assess the feasibility and safety of
intermittent infusions of MTX-110 administered by convection
enhanced delivery (CED) via implanted refillable pump and catheter.
The study aims to recruit two cohorts, each with a minimum of four
patients; the first cohort will receive MTX-110 only and the second
cohort will receive MTX-110 in combination with lomustine.
The first patient in the study was dosed at 60uM of MTX-110 via
direct-to-tumour delivery and has received four 48-hour infusions
over a period of four weeks. No treatment-associated adverse events
were noted in the patient during this period. Following successful
completion of the first month of treatment, the DSMB reviewed the
available data on 11 January 2023 and recommended dose escalation
in the study to 90uM. This dose is expected to be the optimal one
of MTX-110 and is the one currently being used in the ongoing Phase
I study of patients with diffuse intrinsic pontine glioma ("DIPG")
at the Columbia University, USA.
Patient 1 continues treatment as per the study protocol and
patient 2 is expected to start treatment by the end of January 2023
and will receive the 90uM dose.
Commenting, Dr Dmitry Zamoryakhin, MD, MBA, CSO of Midatech,
said : "This represents encouraging progress for the MAGIC-G1
study. As the study protocol is based on an accelerated dose
escalation approach, with no adverse events seen in the first study
patient we are now able to escalate the dose to the concentration
that is expected to be optimal in the development of MTX-110.
Depending on the safety profile of the higher dose, the study will
need to recruit a minimum of 3 more patients before possible
progression to the next cohort."
About Glioblastoma ("GB")
GB is the most common and devastating primary malignant brain
tumour in adults encompassing 14.3% of all primary brain and
central nervous system neoplasms(1) . With an incidence of
approximately 3.2 per 100,000 population in the USA, approximately
12,300 people in the USA will be diagnosed with GB per annum.
Standard of care for treatment of GB is typically maximal surgical
resection followed by radiotherapy plus concomitant and maintenance
temozolomide chemotherapy with or without the Optune(R) device.
Notwithstanding, the multidisciplinary approach, almost all
patients experience tumour progression with nearly universal
mortality. The median survival from initial diagnosis is less than
21 months(2) .
Currently, no standard of care is established for rGB.
Sources:
(1) Low JT, Ostrom QT, Cioffi G, Neff C, Waite KA, Kruchko C,
Barnholtz-Sloan JS. Primary brain and other central nervous system
tumors in the United States (2014-2018): A summary of the CBTRUS
statistical report for clinicians. Neurooncol Pract. 2022 Feb
22;9(3):165-182. doi: 10.1093/nop/npac015. PMID: 35601966; PMCID:
PMC9113389.
(2) Stupp R, Taillibert S, Kanner AA, et al. Maintenance Therapy
With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone
for Glioblastoma: A Randomized Clinical Trial. JAMA : the journal
of the American Medical Association. 2015;314(23):2535-2543.
Chinot OL, Wick W, Mason W, et al. Bevacizumab plus
radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl
J Med. 2014;370(8):709-722.
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).
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR) as it forms part of
UK domestic law by virtue of the European Union (Withdrawal) Act
2018, as amended.
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 (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)
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 announcement 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,
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