Biodexa Pharmaceuticals
PLC(“Biodexa” or the “Company”)
Biodexa Completes Recruitment of Cohort A
in Study of MTX110 in Patients with Recurrent
Glioblastoma
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 that it has completed recruitment into cohort A
of its ongoing Phase 1 study of MTX110 (also known as MAGIC-G1
study)(NCT 05324501) in patients with recurrent glioblastoma
(rGBM).
MAGIC-G1 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 (A and B), with a minimum of four patients in
each; while patients in both cohorts receive MTX110 via
intermittent repeated CED infusions, patients in the B cohort will
be allowed CED catheter repositioning upon first in-study clinical
and/or radiographic confirmed progression.
Following review by the Data Safety
Monitoring Board (DSMB), the dose was escalated to 90µM after
the first patient in cochort A and, because there have been no
dose-limiting toxicities, recruitment into this cohort has
concluded with the minimum of four patients. Patient 1 received 13
treatment cycles over 19 weeks of study treatment period, whereas
patient 2 received 10 cycles over 13 weeks of study treatment
period; patient 3 has, to date, received five cycles of treatment.
The fourth patient underwent surgery yesterday and will receive
their first cyle of treatment imminently.
Enrolment in cohort B will commence upon
approval by the study DSMB, which is anticipated to be received
towards the end of October 2023.
In addition, the Company is planning to add two
more investigational centres into the study with activation
expected in December 2023 and January 2024, respectively.
Commenting, Dr Dmitry Zamoryakhin, MD,
MBA, CSO of Biodexa, said: “We are delighted to have
concluded the recruitment of cohort A with the minimum number of
patients based on the absence of drug-related adverse events.
Cohort B of the study will provide a unique opportunity of
continuous CED treatment after in-study tumour progression, which
will be the first of its kind.”
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® 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-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),
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 Ltd. |
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 therapeutic 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.
Biodexa Pharmaceuticals (NASDAQ:BDRX)
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