July/August 2023 • PharmaTimes Magazine • 8

// RESEARCH //


Owlstone Medical delivers breath biopsy test data

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Owlstone Medical – a company developing breath biopsy tests for early disease detection – has announced emerging data on the development of a screening test for the early detection of lung cancer.

Research progress was duly presented at the EACR 2023 Congress – the yearly meeting of the European Association for Cancer Research.

The company’s phase 1 study demonstrated Owlstone’s efforts to establish D5-ethyl-ß-glucuronide as a non-invasive probe for early cancer detection.

Prior research had already established its ability to detect D5-ethanol cleaved from the probe through the action of extracellular ß-glucuronidase in human cancer xenografted mice.

Following this, Owlstone determined the presence of extracellular ß-glucuronidase in tissue samples from human lung cancers, along with the ability to reliably detect D5-ethanol in human breath samples through ‘breath biopsy’ after administration of the Exogenous Volatile Organic Compound (EVOC) probe.

Meanwhile, in-human studies are now underway with phase 1a safety assessment and phase 1b dose optimisation study almost complete.

Preliminary data has shown excellent safety, while also demonstrating proof of mechanism through the measurement of D5-ethanol levels in breath samples among lung cancer patients.

Billy Boyle, co-founder and chief executive officer of Owlstone Medical, was optimistic about the progress of the tests: “Through the studies presented, we are now confident we have the evidence we need to proceed to phase 2 of the EVOLUTION study.”


Invizius’ ‘angry blood’ research recruits 300th patient

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Invizius – a company focusing on second generation therapies autoimmune conditions – has announced that the 300th patient has been recruited to its ‘angry blood’ study.

The novel kinetic research has been designed to identify patients with elevated complement responses during haemodialysis (HD), also known as ‘angry blood’. It has also been developed to establish those individuals that may have a greater risk of serious cardiovascular complications – the major cause of mortality among HD patients.

The 525-patient trial intends to assess ‘complement activation’ during HD in patients with end-stage renal failure and its wider link to the patient’s risk of serious complications during dialysis.

Meanwhile, dialysis patients from partnering institutions such as Royal Preston Hospital, Salford Royal NHS Foundation Trust and Liverpool Royal Infirmary, will be participating in the ongoing study. This network will allow Invizius to stratify the patient population in preparation for the upcoming first-in-human study of its H-Guard priming solution.

Subject to approvals by the Medicines and Healthcare products Regulatory Agency (MHRA), this research will begin later in 2023.

Dr Andy Herbert, chief technology officer at Invizius, elaborated: “We are only halfway through our ‘angry blood’ study but the kinetic data on complement and immune activation we are obtaining is providing valuable insights into the problems faced by a number of dialysis patients.”