The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given formal approval for Redx to re-commence a Phase I/IIa trial of experimental cancer therapy RXC004.
RXC004 is an oral porcupine inhibitor targeting the Wnt signalling pathway, with the Phase I/IIa trial on track to resume in the first half of 2019.
Lisa Anson, chief executive of the firm, 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 UK on this exciting programme.”
On successful completion of this initial Phase I 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.