A senior Addenbrooke’s early phase trials researcher has praised patients, staff and sponsors who backed a landmark trial which could be a “game changer” in the battle to prevent repeat heart attacks.
He spoke out after the remarkable results, and how they achieved them, were revealed at the largest cardiology conference globally in London on Friday (30 August).
The eagerly-awaited late-breaking session of the 30th European Society of Cardiology (ESC) Congress heard that after Addenbrooke’s and Royal Papworth patients took a re-purposed cancer drug called aldesleukin, it significantly reduced markers on inflammation on specialised PET-CT scans.
The results – gathered over four years including over the pandemic and involving 60 patients - provides the impetus to carry out larger studies to determine if the drug can be approved for mainstream use and support other therapies.
CUH consultant clinical pharmacologist, affiliated associate professor and trial chief investigator, Dr Joseph Cheriyan, said:
I would like to thank all those who have made this trial possible – world class university researchers, specialist clinicians, pharmacists, sponsors, and most of all the patients who volunteered.
All visits were conducted in our dedicated Cambridge Clinical Research Centre - which has some of the best facilities in the country and were scanned on our state-of-the-art PET-CT scanners.
All this was possible because of the huge investment of the National Institute for Health and Care Research (NIHR) on our campus and in bringing together these specialist teams. The results could be game-changing.
Dr Joseph Cheriyan
The trial was conceived by BHF Professor of cardiovascular medicine, UoC, Ziad Mallat, who was the principal grant holder of the Medical Research Council grant together with Dr Cheriyan, Professor James Rudd and Dr Stephen Hoole at Royal Paworth Hospital. The Cambridge Clinical Trials Unit oversaw the conduct of the study.
The results were presented at the ESC congress by Dr Rouchelle Sriranjan, an interventional cardiology registrar and NIHR clinical lecturer in cardiology. The team will publish their data in a peer-reviewed academic journal in the coming months.
The technique to use PET-CT to detect inflammation was initially developed by Professor Rudd almost 20 years ago. Since then, it has been shown that high levels of inflammation in blood vessels are linked to an increased risk of heart disease and heart attacks. After a heart attack, the body’s immune response can aggravate existing inflammation, causing more harm and increasing risk. Professor Mallat came up with a novel idea to boost protective immune cells with low doses of a licensed drug called aldesleukin.
The researchers found that when injected under the skin of patients after a heart attack, there was a significant reduction in inflammation in the arteries.
Patients received an injection once a day for the first five days, then once per week over the next seven weeks. Neither participants, nor their doctors, knew whether they had received the drug or placebo.
To date there have been no major adverse cardiac events in the group that received aldesleukin, and researchers are following up patients to investigate the longer-term impact.
The work, called IVORY and followed up with the IVORY FINALE trial, was led by researchers at Cambridge University Hospitals (CUH), the University of Cambridge (UofC) and Royal Papworth Hospital.
It was supported by the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre, and the NIHR Cambridge Clinical Research Facility (CRF).