Publication of Manuscript from the PNOC015 (a.k.a. MTD-201) Study in Patients with Diffuse Midline Glioma (DMG)
July 06 2023 - 8:15AM
6 July 2023
Biodexa Ltd(“Biodexa” or the
“Company”)
Publication of Manuscript from the
PNOC015 (a.k.a. MTD-201) Study in Patients
with Diffuse Midline Glioma (DMG)
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a
clinical stage biopharmaceutical company developing a pipeline of
products aimed at primary and metastatic cancers of the brain, is
pleased to announce the publication of the results of an
investigator-initiated Phase I study PNOC015 (also known as
MTD-201) of MTX110 in the treatment of pediatric patients with DMG
(formerly known as Diffuse Intrinsic Pontine Glioma, or DIPG) in
the Journal of Neuro-Oncology (NCT 03566199).
The study recruited seven pediatric patients
with confirmed diagnosis of DMG, after radiation therapy.
Convection Enhanced Delivery (CED) of MTX110 at doses escalating
from 30µM to 90μM was performed, with a total of 48 infusions
across all patients. The study has demonstrated acceptable safety
profile of the treatment (three patients reported dose-limiting
toxicities) and encouraging efficacy with median overall survival
(OS) of 26.1 months comparing favourably with historical data of OS
of 10.0 months.
The study manuscript is available at:
https://pubmed.ncbi.nlm.nih.gov/37318058/
Commenting, Dr Dmitry Zamoryakhin MD,
Chief Scientific Officer of Biodexa said: “We are
extremely pleased with the outcome of this study that gave a first
controlled insight into the safety ane efficacy of intra-tumoral
administration of MTX110 via CED. This study is now been followed
up by a further Phase I study at Columbia University”.
About DMG
DMG is a primary brain tumour arising in the
pons (middle) of the brain stem, is diffusely infiltrating and
cannot be surgically removed. Occurring mostly in children, the
median survival rate in a cohort of 316 cases was 10.0 months and
OS12 was 35% (Jansen et al, 2015. Neuro-Oncology 17(1):160-166).
Although radiotherapy prolongs survival, the majority of patients
die within one year following diagnosis. Systemic chemotherapy is
ineffective, often due to an inability of agents to cross the
blood-brain barrier. Approximately 1,100 (data on file) individuals
are diagnosed with DIPG worldwide each year.
About MTX110
MTX110 is a water-soluble form of panobinostat
free base, achieved through complexation with
hydroxypropyl-β-cyclodextrin (HPBCD), that enables 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®) 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 recurrent
glioblastoma (NCT05324501), paediatric DMG (NCT04264143) and
recurrent medulloblastoma (NCT04315064). 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 and GBM 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:
Biodexa Pharmaceuticals PLC |
Dmitry Zamoryakhin, CSO |
Tel: +44 (0)29 20480 180 |
www.biodexapharma.com |
Edison Group (US Investor
Relations) |
Alyssa
Factor |
Tel: +1 (860) 573
9637 |
Email:
afactor@edisongroup.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a
clinical stage biopharmaceutical company developing a pipeline of
products aimed at primary and metastatic cancers of the
brain. The Company’s lead candidate, MTX110, is being studied
in aggressive rare/orphan brain cancer indications including
recurrent glioblastoma and diffuse midline glioma.
MTX110 is a liquid formulation of the histone deacetylase (HDAC)
inhibitor, panobinostat. This proprietary formulation enables
delivery of the product via convection-enhanced delivery (CED) at
potentially chemotherapeutic doses directly to the site of the
tumour, by-passing the blood-brain barrier and avoiding systemic
toxicity.
Biodexa is supported by three proprietary drug delivery
technologies focused on improving the bio-delivery and
bio-distribution of medicines. Biodexa’s headquarters and
R&D facility is in Cardiff, UK. For more information
visit www.biodexapharma.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
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995 and are based on
management’s belief or interpretation. All statements
contained in this announcement that do not relate to matters of
historical fact should be considered forward-looking
statements.
Reference should be made to those documents that
Biodexa shall file from time to time or announcements that may be
made by Biodexa in accordance with the rules and regulations
promulgated by the SEC, which contain and identify 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 Biodexa are
expressly qualified in their entirety by the cautionary statements
above. Except as may be required under relevant laws in the
United States, Biodexa does not undertake any obligation to
publicly update or revise any forward-looking statements because of
new information, future events or events otherwise arising.
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