Redx Pharma plc RXC004 Trial Approval (5710N)
21 January 2019 - 6:00PM
UK Regulatory
TIDMREDX
RNS Number : 5710N
Redx Pharma plc
21 January 2019
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REDX PHARMA PLC
("Redx" or "the Company")
Redx to resume RXC004 clinical trial programme
MHRA grants approval for trial restart
Phase 1/2a trial on track to resume in H1 2019
Alderley Park, 21 January 2019 Redx (AIM: REDX), the drug
discovery and development company focused on cancer and fibrosis,
announces that the UK's Medicines and Healthcare products
Regulatory Agency (MHRA) has given formal approval to the Company
to re-commence the phase 1/2a trial for RXC004, an oral porcupine
inhibitor targeting the Wnt signalling pathway. Clinical evaluation
of RXC004 in patients with advanced solid tumours remains on track
to resume in H1 2019 following the approval of a revised phase 1/2a
clinical trial protocol and drug formulation. Redx, together with
the study investigators, now believe that the desired systemic
exposure can be achieved using a significantly lower starting dose
with the potential for clinical benefit(1) .
Natalie Cook, Consultant Oncologist and Principal Investigator
from the Christie Hospital in Manchester, UK commented: "We have
learnt a significant amount from the first patient treated with
RXC004, and this provides the basis for an optimised RXC004
development plan as well as the confidence to evaluate the clinical
potential of RXC004 in cancer patients."
Lisa Anson, Chief Executive Officer, Redx Pharma plc commented:
"I am delighted that Redx is on track to resume clinical evaluation
of RXC004 in patients with advanced solid tumours in the first half
of 2019. We believe that the revised RXC004 clinical protocol and
development plan has the potential to offer clinical benefit both
as a monotherapy and in combination with standard of care
treatments. We look forward to working closely with our expert
clinical oncology colleagues across the U.K. on this exciting
programme."
On successful completion of this initial phase 1 monotherapy
study, RXC004 has the potential to be developed in different
cancers and in different treatment settings with major unmet
medical need based on two distinct mechanisms of actions: as an
immuno-oncology agent and by direct tumour targeting in patients
with upstream Wnt signalling pathway alterations.
[1] The primary objective of the study remains the safety and
tolerability of the drug
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
920
Lisa Anson, Chief Executive Officer
Andrew Saunders, Chief Medical Officer
Cantor Fitzgerald Europe (Nominated Advisor & T: +44 20 7894
Joint Broker) 7000
Phil Davies
WG Partners LLP (Joint Broker) T: +44 20 3705
9330
Claes Spång/ Chris Lee/ David Wilson
FTI Consulting T: +44 20 3727
1000
Simon Conway/Stephanie Cuthbert
About Redx Pharma Plc
Redx is a UK based biotechnology company whose shares are traded
on AIM (AIM:REDX). Redx's vision is to become a leading biotech
focused on the development of novel precision medicines that have
the potential to transform treatment in oncology and fibrotic
diseases.
If you would like to sign up to regular alerts from Redx Pharma,
please follow this link
https://www.redxpharma.com/investors/email-alerts/
About RXC004 and the Clinical Programme
RXC004 is a novel, oral, potent small molecule Porcupine
inhibitor, which targets the Wnt signalling pathway. Porcupine is a
recognised drug target on the Wnt cell signaling pathway. The Wnt
signalling pathway is an embryonic signalling pathway that is
implicated in the maintenance of cancer stem cells in multiple
cancer types. This pathway is associated with tumorigenesis,
metastasis, recurrence and resistance in cancer. There is now also
strong evidence that this pathway plays a key role in how tumours
avoid detection by the patient's own tumour fighting immune cells,
tumours of this type have been termed "cold" tumours.
The first-in-man clinical trial for this drug is a modular,
multi-arm, multi-part, Phase 1/2a, adaptive design study whose
primary objective is to evaluate the safety and tolerability of the
drug in patients with advanced malignancies. It is anticipated that
a total c.50 patients will be enrolled. (ClinicalTrials.gov
Identifier: NCT03447470). In the first part of the study patients
are allocated to a dose and followed for a period of time for
potential dose limiting toxicities. Under the proposed amended
protocol patient dosing will be recommenced at 0.5mg as opposed to
the original starting dose of 10mg. Dose-escalation will then occur
stepwise in subsequent groups of patients until a maximum tolerated
dose or evidence of anti-tumour effects are observed.
As previously announced, following treatment of the first
patient, Redx suspended recruitment to its phase 1/2a clinical
study for RXC004 in March 2018. This was due to the observation of
clinically significant adverse events, which were believed to be
related to the on-target effects of RXC004 on the inhibition of the
Wnt signalling pathway. Further analysis of clinical data from this
first patient indicated that the systemic RXC004 exposure was
significantly higher than that predicted from pre-clinical animal
studies. While the maximum plasma concentration of the drug (C(max)
) was in line with expectations, the terminal half-life of the drug
(t(1/2) ) was significantly longer than that predicted from such
animal models, due to the actual rate of elimination being lower.
The Company believes that higher drug exposure in humans compared
to pre-clinical studies is not uncommon in first in human clinical
studies of experimental drugs. It arises from differences between
the metabolism observed in the animals used in pre-clinical models
versus that observed when administered to humans for the first
time.
*** ENDS****
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