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Redx Pharma receives regulatory green light to restart cancer trial

RXC004 is one of a new breed of immune-oncology treatments currently in clinical development

woman researcher working in lab
The early-stage clinical trial will start in the first-half of next year

Redx Pharma PLC (LON:REDX) has confirmed it will restart a Phase I/IIa clinical trial of its lead cancer drug in the first half of next year – but at a much reduced dose.

It follows what it described as a “positive” meeting with the Medicines and Healthcare products Regulatory Agency, the drugs watchdog.

WATCH: Redx Pharma's chief medical officer discusses lead oncology drug RXC004

As well as the newly-proposed lower starting dose of RXC004, there will be a revised study protocol, including enhanced safety monitoring.

If it successfully negotiates this early phase clinical assessment, the drug will then be tested in harness with immune checkpoint inhibitors to target solid tumours such as colorectal cancer.

RXC004 is one of a new breed of immune-oncology treatments currently in clinical development.

The so-called Porcupine inhibitor helps enhance the body’s own immune system to tackle what is known as cold tumours that avoid detection by turning them ‘hot’.

Redx chief executive Lisa Anson said she was “pleased” the previously-suspended trial had received the green light to restart.

“We look forward to submitting our final protocol amendments, with the aim of initiating the next patient in the first half of 2019,” she added.

“I would like to thank my colleagues at Redx and our clinical investigators for all their hard work that has resulted in our phase I/IIa proposal being positively received by the MHRA.”

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