Redx Pharma plc RXC004 Clinical Trial Update (3245J)
March 29 2018 - 1:01AM
UK Regulatory
TIDMREDX
RNS Number : 3245J
Redx Pharma plc
29 March 2018
REDX PHARMA PLC
("Redx" or "the Company")
RXC004 Clinical Trial Update
Alderley Park, March 29 2018 - Redx (AIM: REDX), the drug
discovery and development company focused on cancer and fibrosis,
announces that it has informed the Medicines and Healthcare
products Regulatory Agency (MHRA, "the Agency") that it is
temporarily interrupting patient accrual to its Phase 1/2a clinical
study for the Porcupine inhibitor, RXC004.
On dosing of the first patient in the trial, clinically
significant adverse events were observed that the company and our
academic colleagues believe are possibly related to RXC004
on-target effects and Wnt pathway inhibition. Importantly, analysis
of data from this first patient indicates that their systemic
RXC004 exposure was significantly higher than that predicted from
preclinical studies.
Dr Andrew Saunders, Chief Medical Officer of Redx Pharma
commented: "It is our current intention to propose a protocol
amendment that enables dose-escalation to re-start at significantly
lower dose levels. This protocol amendment will be finalised with
consultation with both the MHRA and principal investigators."
Iain Ross Executive Chairman added: "The Board continues to
believe the overall risk/benefit assessment of RXC004 as an
investigational drug is unchanged. However, in drug development,
safety of patients is the first priority and it is appropriate that
the Board and management has taken the decision to suspend
recruitment of further patients to the trial until the Company has
consulted with the MHRA and agreed a plan to move forward. While we
remain confident that we can address this issue, we currently
estimate that that this suspension will lead to a delay of several
months. The Board continues to believe it has sufficient resources
to continue to progress RXC004 and its broader portfolio of
oncology and fibrosis assets. We intend to provide a further update
in due course."
Background
RXC004 is a novel, oral, potent small molecule Porcupine
inhibitor, which targets the Wnt pathway, 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.
This first-in-man clinical trial of RXC004 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 time for
potential dose limiting toxicities. Once this period is complete
the protocol dictates that the next arm of the study will be at a
higher dose until a maximum tolerated dose is reached.
For further information, please contact:
Redx Pharma Plc T: +44 1625
469 918
Iain Ross, Executive Chairman
Cantor Fitzgerald Europe (Nominated T: +44 20
Advisor & Broker) 7894 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 biotechnology company whose shares are traded on
AIM (AIM:REDX). Redx is focused on creating and developing first,
or potentially best in class drugs, in specific areas of cancer and
fibrosis that address significant unmet medical need. Redx has an
in-house discovery team with proven world-class chemistry
capabilities.
This information is provided by RNS
The company news service from the London Stock Exchange
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