TIDMMTPH
RNS Number : 2215G
Midatech Pharma PLC
14 November 2022
14 November 2022
Midatech Pharma PLC
("Midatech" or the "Company")
First Patient Enrolled 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 the enrolment
of the first patient into its Phase 1 study of MTX110 in recurrent
glioblastoma (rGB) (NCT 05324501) at the Preston Robert Tisch Brain
Tumor Center at Duke University, USA.
The Phase I study is an open-label, dose escalation study
designed to assess the feasibility and safety of intermittent
infusions of MTX110 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 MTX110 only and the second cohort will
receive MTX110 in combination with lomustine.
Midatech has previously reported encouraging results from a
Phase I study of MTX110 in diffuse intrinsic pontine glioma
("DIPG") conducted by University of California, San Francisco with
an additional Phase I study of MTX110 in DIPG conducted by Columbia
University expected to report shortly. In addition, a Phase I study
of MTX110 in medulloblastoma is being undertaken at the University
of Texas.
MTX110 has been granted Orphan Drug and Fast Track designations
by the FDA and Orphan Medicinal Product designation by EMA.
Commenting, Dmitry Zamoryakhin, MD, MBA, CSO of Midatech, said:
"rGB is a devastating and incurable cancer marked by short survival
rates and universal recurrence. A start of recruitment into the
MAGIC-G1 study marks a significant step towards developing a
potential new treatment paradigm for patients with this devastating
disease that currently has limited effective treatment
options."
Commenting, Annick Desjardins, MD, FRCPC, neuro-ongologist,
professor of neurosurgery and neurology at Duke University and
study's principal investigator, said: "We are excited to be a
leading center for the MAGIC-G1 study that is looking to overcome
the limited penetration of panobinostat through the blood-brain
barrier by its direct administration into the tumor, thus also
potentially avoiding systemic toxicity."
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.
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).
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.
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 / 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 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
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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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