Redx Pharma plc First cohort of patients dosed in RXC004 study (4081J)
August 19 2019 - 1:00AM
UK Regulatory
TIDMREDX
RNS Number : 4081J
Redx Pharma plc
19 August 2019
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REDX PHARMA PLC
("Redx" or "the Company")
First Cohort of Patients Successfully Dosed in RXC004 Phase 1/2
Study; Second Cohort Enrolment Has Now Begun
Alderley Park, 19 August 2019 Redx (AIM: REDX), the drug
discovery and development company focused on cancer and fibrosis,
announces that it has successfully completed dosing of the first
cohort of patients in its ongoing phase 1/2 study with RXC004.
Following a review of the data from this cohort, the Safety Review
Committee has recommended that the dose can now be escalated.
Consequently, recruitment of the second patient cohort, who will be
administered the drug at a higher pre-specified dose of RXC004, has
begun as per the trial protocol.
RXC004 is an oral porcupine inhibitor targeting the Wnt
signalling pathway. 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. The Phase 1
monotherapy dose-escalation study is expected to complete in H1
2020 along with start of monotherapy dose-expansion.
Lisa Anson, Chief Executive Officer of Redx Pharma added: "We
are pleased that the Safety Review Committee has recommended that
we can now escalate the dose in the phase 1 /2 study of RXC004, our
oral porcupine inhibitor, and consequently we have begun enrolment
of our second cohort of patients as per protocol. We believe that
RXC004 has the potential to offer clinical benefit both as a
monotherapy and in combination with standard of care treatments for
patients with Wnt-driven advanced solid tumours. We look forward to
completing patient enrolment for the phase 1 monotherapy
dose-escalation study and to announcing results during 2020."
Background on 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 signaling pathway which 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;
often termed as "cold" tumours.
The first-in-man clinical trial for RXC004 is a modular,
multi-arm, multi-part, Phase 1/2, 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 of 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 protocol, patient
dosing of the first cohort was at 0.5mg and 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 1/2 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. Following discussions with the Company, the UK's Medicines
and Healthcare products Regulatory Agency (MHRA) approved a revised
phase 1/2 clinical trial protocol and drug formulation in January
2019, allowing re-commencement of the RXC004 study.
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/Ciara Martin
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.
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END
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