Biotechnology firm 4D Pharma announced a world first yesterday, saying it would launch clinical trials of a revolutionary new cancer treatment later this year.
The move has just been cleared by the Medicines and Healthcare Products Regulatory Agency, which regulates medicines, medical devices and blood transfusion components in the UK.
4D Pharma, which grew out of Aberdeen University Rowett Institute spinout GT Biologics, is developing treatments based on live biotherapeutics. These are a relatively new group of medicines that use the bacteria which colonise the human body the microbiome – to tackle disease.
As well as helping digestion and the production of vitamins, the bacteria have an important role in regulating the immune and central nervous systems.
Announcing its move towards clinical trials of its MRx0518 cancer treatment yesterday, 4D Pharma said enrolment was likely to start during the second half of 2018. An initial two-part study will evaluate the “safety, tolerability and anti-tumour immuno-modulatory effects” of MRx0518 in patients with different types of cancer.
Patients taking part in the tests will not have received any previous cancer therapies and will receive MRx0518 for the period between their diagnosis and surgery.
A total of 140 cancer patiets will receive either MRx0518 or a placebo.
In addition to assessing safety and tolerability, tumour, blood and stool samples will be taken before and after treatment to investigate the effect of MRx0518 on a range of immunological markers and the gut microbiome. Survival will also be investigated up to two years post-surgery.
Duncan Peyton, chief executive of 4D Pharma, said: “This groundbreaking study is set to be the world’s first live biotherapeutic clinical trial in oncology and the first of a number of studies we have planned to investigate MRx0518 in multiple cancer settings.
“The novel design of this trial provides an unrivalled opportunity to evaluate the immuno-modulatory properties of MRx0518 and how our approach using live biotherapeutics could advance a new approach to the understanding of the treatment of cancer.” The company is headquartered in Leeds but carries out much of its research at Aberdeen University’s Foresterhill campus.
