Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients
09 February 2024 - 12:30AM
Biodexa Pharmaceuticals PLC
Biodexa Reports 12 Month Survival in
MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma
Patients
CARDIFF, United Kingdom, February 8, 2024 (GLOBE
NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the
“Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical
company developing a pipeline of innovative products for the
treatment of diseases with unmet medical needs including Type 1
diabetes and rare/orphan brain cancers, today provided survival
updates from its MAGIC-G1 study (NCT05324501) of MTX110 in patients
with recurrent glioblastoma (“rGBM”) being conducted at Duke Cancer
Institute and Baptist MD Anderson Cancer Center.
In October 2023, Biodexa announced completion of
recruitment of Cohort A of an ongoing open-label Phase I
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. Because no drug-related adverse events were observed
within the first 30 days from start of treatment, the minimum
number of four patients were recruited into Cohort A.
Patient #1 received weekly infusions of 60µM of
MTX110 and survived for 12 months from the start of treatment
(OS=12).
Patients #2, 3 and 4 each received weekly
infusions of 90µM of MTX110, the expected optimum dose, and remain
in the study.
GBM universally recurs and once it does median
overall survival according to a retrospective analysis of 299
patients reported in the Journal of Neuro-Oncology is 6.5 months1.
Currently, no standard of care is established for rGBM.
About Glioblastoma Multiforme
(GBM)
GBM is the most common and devastating primary
malignant brain tumour in adults with incidence of 3 -4 per 100,000
population2. Standard of care for treatment of GBM is typically
maximal surgical resection followed by radiotherapy plus
concomitant and maintenance temozolomide chemotherapy.
Notwithstanding, the multidisciplinary approach, almost all
patients experience tumour progression with nearly universal
mortality.
About MTX110
MTX110 is a water-soluble form of panobinostat
free base, achieved through complexation with
hydroxypropyl-β-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®) 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),
Diffuse Midline Glioma (“DMG”) (NCT04264143) and recurrent
medulloblastoma (NCT04315064), and preclinically for treatment of
Leptomeningeal Disease. 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 DMG cell lines
(Grasso et al, 2015. Nature Medicine 21(6), 555-559).
- J Neurooncol. 2017; 135(1):
183–192
- Cancers | Free Full-Text |
Epidemiology of Glioblastoma Multiforme; Literature Review
(mdpi.com)
For more information, please contact:
Biodexa Pharmaceuticals PLC |
Stephen Stamp, CEO, CFO |
Tel: +44 (0)29 20480 180 |
www.biodexapharma.com |
Edison Group (US Investor Relations) |
Laine Yonker |
Tel: +1 (610) 716
2868 |
Email:
lyonker@edisongroup.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ:
BDRX) is a clinical stage biopharmaceutical company developing a
pipeline of innovative products for the treatment of diseases with
unmet medical needs. The Company’s lead development programmes
include tolimidone, under development as a novel agent for the
treatment of type 1 diabetes and MTX110, which is being studied in
aggressive rare/orphan brain cancer indications, and
Tolimidone is an orally delivered, potent and
selective inhibitor of lyn kinase. Lyn is a member of the Src
family of protein tyrosine kinases, which is mainly expressed in
hematopoietic cells, in neural tissues, liver, and adipose tissue.
Tolimidone demonstrates glycemic control via insulin sensitization
in animal models of diabetes and has the potential to become a
first in class blood glucose modulating agent.
MTX110 is a solubilised formulation of the
histone deacetylase (HDAC) inhibitor, panobinostat. This
proprietary formulation enables delivery of the product via
convection-enhanced delivery (CED) at chemotherapeutic doses
directly to the site of the tumour, by-passing the blood-brain
barrier and potentially 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. In
certain cases, forward-looking statements can be identified by the
use of words such as “plans”, “expects” or “does not anticipate”,
or “believes”, or variations of such words and phrases or
statements that certain actions, events or results “may”, “could”,
“would”, “might” or “will be taken”, “occur” or “be
achieved.” Examples of forward-looking statements include,
among others, statements we make regarding our pre-clinical
data and clinical trials. Forward-looking statements and
information are subject to various known and unknown risks and
uncertainties, many of which are beyond the ability of the Company
to control or predict, that may cause their actual results,
performance or achievements to be materially different from those
expressed or implied thereby, and are developed based on
assumptions about such risks, uncertainties and other factors set
out herein.
Reference should be made to those documents that
the Company shall file from time to time or announcements that may
be made by the Company in accordance with the rules and regulations
promulgated by the United States Securities and Exchange
Commission, 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
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their entirety by the cautionary statements above. Except as
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Company 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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