Biodexa Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update
February 23 2024 - 7:30AM
Biodexa Pharmaceuticals
PLC(“Biodexa” or the “Company”)
Biodexa Announces Positive Top Line Phase
I Clinical Trial Results for Diffuse Midline Glioma and Provides
R&D Update
Median Overall Survival of 16.5 Months vs 10.0
months in Comparable Cohort
CARDIFF, United Kingdom, February 23, 2024
(GLOBE NEWSWIRE) – Biodexa Pharmaceuticals PLC, (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, announces an R&D update including positive top-line
clinical trial results of a recently completed Phase 1 study of
MTX110 in patients with diffuse midline glioma, or DMG, and results
of a preclinical experiment designed to demonstrate tolimidone’s
potential for beta cell proliferation in an in vitro model.
MTX110
In an investigator initiated study conducted by
Columbia University Irving Medical Center, patients newly diagnosed
with DMG were administered MTX110 via convection enhanced delivery
(“CED”) using a subcutaneous pump connected to a catheter directly
implanted into the pons in a 3+3 dose-escalating design (NCT
04264143). As this was the first ever study of repeated infusions
to the pons via an implanted CED catheter, the primary objective of
the study was safety and tolerability and, accordingly, the number
of infusions was limited to two, each of 48 hours, 7 days apart.
Nine patients were treated in the study (30 M group, n=3; 60 M
group, n=4; 90 M group (optimal dose), n=2). One patient in the 60
M group suffered a severe adverse event assessed by the
investigators as not related to the study drug but related to the
infusion and tumor anatomy. Although the study was not powered to
reliably demonstrate efficacy, median overall survival (OS) of
patients in the study was 16.5 months. This compares favourably
with median survival rate in a cohort of 316 cases of 10.0 months
(Jansen et al, 2015. Neuro-Oncology 17(1):160-166).
Study investigators are planning to present
detailed results of the trial at the 21st International Symposium
on Pediatric Neuro-Oncology (ISPNO 2024) being held on June 28-July
2, 2024 in Philadelphia, PA.
Tolimidone
On the Company’s behalf, a CRO conducted an in
vitro experiment designed to demonstrate tolimidone’s potential for
beta cell proliferation using reaggregated pancreatic islets. The
results of the experiment were inconclusive in that they did not
correlate with the results previously seen in in vitro and in
vivo studies of tolimidone. The Company believes there are a few
possible explanations to the outcome of this in vitro study and
accordingly, plans to move ahead rapidly with an in vivo
preclinical study with similar objectives while continuing
preparations for its planned Phase IIa open-label study of
tolimidone in patients with Type 1 diabetes due to start
recruitment later this year.
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) |
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
statements by or concerning the Company are expressly qualified in
their entirety by the cautionary statements above. Except as
may be required under relevant laws in the United States, the
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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