Official approval has been given to Redx Pharma plc to recommence its 1/2a phase of clinical trials for RXC004, giving hope for fresh developments in the treatment advanced cancers.
Reignited Hope for Cancer Treatment
RedX Pharma began their trial of the RXC004 to target solid advanced cancers in recruited participants. The trial was temporarily paused in March 2018 due to clinically significant adverse observations during the treatment of the trial’s first patient. Data obtained suggested the inhibition of the Wnt pathway but also much higher RXC004 exposure than predicted. The amendment to protocol agreed with MHRA is hoped to achieve the desired RXC004 exposure and improve safety and efficiency of the drug treatment.
The approval was given by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to restart trials, allowing for the resumption in 2019 of H1 with the drug on a reduced starting dose. This part of the trial will hope to confirm optimal dosage and look at the pharmacokinetics of the drug as well as identify any side-effects during treatment. Following the news of the green light to restart the trial, shares in Redx Pharma rose by 10%.
Putting the Results to Use
RedX Pharma’s Chief Executive Officer, Lisa Anson, believes the clinical protocol could potentially offer developments in treatment for different advanced cancers both in addition to standard treatments and as a form of monotherapy. It could be used conjunctively with immune-oncology treatments, such as the already in use Anti-Pd-1 checkpoint inhibitors, and as a targeted biomarker-biomarker-guided therapy in genetically linked cancers, such as gastric, pancreatic and colorectal cancers.
The Consultant Oncologist and Principal Investigator at Manchester’s Christie Hospital, Natalie Cook, states that much has already been learned from the first patient who has undergone treatment with the drug.
Specialised providers that deliver adaptive phase 1 clinical studies, such as richmondpharmacology.com/specialist-services/adaptive-phase-i-studies, are vital in paving the way forward for understanding cancer and developing targeted treatments.
The Science Behind the Trial
The porcupine inhibitor drug RXC004 was developed for patients with solid tumours. It specifically targets the Wnt signalling pathway, understood to be significantly involved in the tumorigenesis, resistance and metastasis of cancer stem cells within different cancers. This pathway is believed to be involved in helping tumours avoid being identified and then targeted by tumour fighting immune cells.