A cross-BHP team from the Royal Orthopaedic Hospital NHS Foundation Trust (ROH) and Aston University has won a place on the SPARK The Midlands programme to help further the development of its minimally-invasive, anti-cancer and bone regenerative injectable paste, which uses the cancer-killing properties of gallium.
SPARK The Midlands provides specialist technical and academic support to advance healthcare research discoveries in the region from the bench to bedside.
The team will use the SPARK programme to secure a clear pathway for the cancer-killing paste to be adopted in clinics and hospitals. If proved effective through clinical trials, the paste – a gallium-doped bioglass – could be used to treat patients with primary and metastatic bone cancer.
Dr Lucas Souza, Research Laboratory Manager at the ROH, said: “Where the global success rate for new ideas making it to clinical trials is less than 5%, SPARK has recorded a project success rate of 62%. Thanks to this programme, the ROH will have the support to develop a regional pipeline for the translation of ideas for orthopaedic and bone cancer applications to NHS-approved medical use.”
World class cancer care needs world class cancer research, so support programmes like SPARK are essential in steering NHS-led research through clinical trials and into patient care.
SPARK is a collaboration between Aston University, the West Midlands Health Tech Innovation Accelerator (WMHTIA) and Forging Ahead. The programme originated at Stanford University in California and has proved hugely impactful in improving the success of innovations making their way to clinical trials and then clinical practice.
A UK-first trial led by Birmingham researchers aims to improve treatment of arthritis in people who have developed the condition as a result of cancer immunotherapy.
The REmission induction of Arthritis caused by Cancer ImmunoTherapy (REACT) trial, led by the University of Birmingham and delivered through the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC), is one of the first global studies of its kind, testing whether powerful arthritis treatment is suitable for patients receiving ongoing cancer treatment.
REACT will recruit 70 patients across the country, and will investigate whether initial treatment with anti-TNF (anti-Tumour Necrosis Factor) therapy in cancer patients receiving a type of immunotherapy called an immune checkpoint inhibitor (ICI), works to better control this type of arthritis – while not negatively impacting their cancer therapy.
Professor Benjamin Fisher, REACT’s Chief Investigator, Professor in Rheumatology at BHP founder member the University of Birmingham, and Lead for the Birmingham BRC’s Inflammatory Arthritis research theme, said: “Immune checkpoint inhibitors have revolutionised cancer treatment, but they come with the risk of severe inflammatory side effects, including arthritis.
“The REACT trial aims to provide critical insights into the most effective initial treatments for patients suffering from this debilitating condition, potentially improving their quality of life significantly without affecting their cancer treatment.”
Immune checkpoint inhibitors are drugs that block the immune system’s inbuilt ‘off’ signals to help it fight cancer. While they are highly effective in treating cancer, they can also cause severe inflammatory side effects, including arthritis – which affects at least 5% of treated cancer patients and significantly impacts quality of life. It may persist even after ICI is stopped and may require treatment with drugs to suppress the immune system.
The typical treatment approach for arthritis that has resulted from ICI treatment is to start with steroid tablets, then gradually try other treatments if these fail. Anti-TNF is currently often the last treatment used.
TNF inhibitors have good evidence for other types of arthritis but there is no evidence for patients with ICI-induced arthritis to safely guide initial treatment strategy, so this trial will be the first to test the effects of immune suppressing drugs on cancer outcomes in response to ICI.
🗞️ BBC Midlands Today spoke to Becky Smith, who has received the new treatment as part of the clinical trial.
Becky (pictured above), 53 and from Solihull, was diagnosed with eye cancer in early 2020. Within weeks, she underwent surgery to remove her eye and adapted quickly to life with an artificial eye. For several years, she remained cancer-free – until the disease spread to her liver.
“I started immunotherapy last year, and while it offered hope, the side effects were brutal,” Rebecca explains. “I developed colitis, meningitis, and severe arthritis that attacked 90% of my joints. I couldn’t climb stairs, get dressed, or even get out of bed without help. It was devastating.”
These side effects forced Rebecca to take a year off work. “I love my job, but I simply couldn’t manage. Every cycle of treatment left me in hospital with side effects. It was a vicious circle.”
Standard steroid therapy offered little relief and clashed with her ongoing immunotherapy. That’s when her consultant suggested the REACT trial.
“I jumped at the chance. I thought, if it doesn’t work, at least I’ve tried – and maybe I’ll help others,” she says.
Rebecca was randomly assigned to receive adalimumab injections every two weeks. The impact was life-changing: “It’s been a godsend. My pain has eased, I can walk, I’ve returned to work, I can even wear heels again! My quality of life is back to what it was before.”
She still experiences mild aches before her next dose, but the improvement has been dramatic. “I’ve gone from being housebound to going on holiday and making memories with my family. Trials like this give people hope – and that’s priceless. Cancer and its side effects aren’t the end of the world. If you get the chance to join a trial, take it. It might change your life – it’s certainly changed mine.”
To compare the safety and effectiveness of these treatment strategies, the trial aims to recruit 70 ICI-induced arthritis patients across multiple centres in the UK. Participants will either receive current standard of care (initial steroid treatment in the form of prednisolone) or the anti-TNF drug adalimumab.
Treatments will be gradually reduced once the arthritis is controlled, or further treatment given if needed. The research team will compare the proportion of patients in each treatment group who have no arthritis and no steroid use 6 months after the start of treatment.
Researchers will also compare how fast the arthritis is controlled, and will continue to follow patients until one year to compare arthritis activity, quality of life, ability to function, total amount of immunosuppressive drugs received over time, number of ICI doses missed, new immune-related side effects, cancer outcomes and survival.
Patients with Idiopathic Intracranial Hypertension (IIH), which causes headaches and potential sight loss, are being invited to take part in new research investigating the impact of weight loss drugs on their condition and eye health.
The IIH Advance trial, coordinated by clinical academics at BHP founder-member the University of Birmingham, aims to recruit 86 people with IIH from around the UK to take part in the trial lasting over a year, which will be delivered in partnership with Specsavers.
IIH is currently considered a rare disease with, affecting approximately 5,000 patients in the UK. It predominantly affects women of childbearing age, and 90% of those living with it also experience obesity. Previous studies at the University have established a direct link between IIH, metabolic dysregulation and obesity, so researchers anticipate that IIH prevalence is set to increase significantly as obesity levels continue to rise.
During the trial, participants will receive the weight loss drug Tirzepatide (commonly known as Mounjaro) and will have Optical Coherence Tomography (OCT) eye scans at a participating branches of Specsavers to monitor swelling of the optic nerves, called papilloedema, which is caused by intracranial pressure.
Dr Maria Lange from the University of Birmingham and co-investigator on the trial said: “IIH is a debilitating condition, and after years of research to better understand the condition, this innovative trial will see whether weight loss, achieved by using the drug Mounjaro could have a significant positive impact for patients.”
“As GLP-1 medicines such as Mounjaro have become available for weight management through the NHS, we hope that the IIH Advance trial will establish a link between losing weight using these drugs and reducing the symptoms of IIH.”
Welcoming the trial, Specsavers’ director of professional advancement Paul Morris said: “IIH is a serious condition that can lead to blindness, and the role that community optometrists and their skilled teams can play in harnessing technology to detect serious eye conditions is pivotal. That’s why regular sight tests are so important. We welcome this innovative trial and are looking forward to collaborating with participants in it as well as the team at the University of Birmingham.”
People with a diagnosis of IIH who have papilloedema and live in the UK will be eligible to take part and are invited to self-nominate themselves to the trial. No doctor’s referral is required, and patients will not need to visit hospital or the trial centre in Birmingham.
Each participant will receive regular deliveries of Mounjaro to their home and will have regular calls with a research team member. They will also undergo eye scans at a participating Specsavers practice at the start of the trial, at six and 12 months, and at the conclusion of the trial.
Dr Jessie Gew, from the University of Birmingham and co-investigator adds: “IIH patients can now directly contact the trial team to self-refer. Once contact is made, our team will work closely with each participant to review relevant medical documentation and confirm eligibility for the study.”
Professor Alex Sinclair, Consultant Neurologist and Professor of Neurology at University of Birmingham, who leads the Idiopathic Intracranial Hypertension Clinical Service at University Hospitals Birmingham NHS Foundation Trust, said : “This trial is an example of the type of pioneering research that could ease pressure on the NHS through innovative community-focused collaboration with industry. We believe that this vision for a trial that streamlines care and empowers patients to participate and receive treatment from the comfort of their own homes is exactly the type of research that the NHS 10-year plan is calling for.”
Academics at BHP founder-member the University of Birmingham will be part of a new Medical Research Council Centre of Research Excellence in Clinical Trial Innovation (MRC CoRE) which aims to speed up patient and participant access to new medicines and trials, for improved patient care.
The Centre, in partnership with the National Institute for Health and Care Research (NIHR), will receive up to £50 million over 14 years to transform the landscape of clinical trials – shaking up approaches to trial design and delivery by developing pioneering new ways to accelerate processes and drive improvements in treatment and recovery.
The University of Birmingham will be one of six leading research intensive institutions to join forces to support MRC CoRE, with Professor Thomas Pinkney bringing his expertise in running complex surgical clinical trials including the ROSSINI-Platform trial, the UK’s largest ever surgical trial to make future operations safer.
MRC CoRE will see UK trials move away from the current approach of testing a single intervention in a single disease one at a time. Finding efficient way to test multiple drugs in multiple diseases at the same time would be a game changer both for industry and the academic community.
Professor Pinkney said: “This new funding will give a major boost to the latent potential around the UK to design and run clinical trials for new treatments for participants and patients.
“Birmingham brings a huge breadth of clinical trials experience both here in the UK and around the world, including surgical trials, complex cancer trials including with children, and many more besides. In addition, the West Midlands offers a unique opportunity with clinical trials for working with a diverse population and socioeconomic background, and so we are ideally placed to help accelerate the development of medicines for patients.”
Professor Patrick Chinnery, Medical Research Council Executive Chair explained: “The UK medical research community is very effective at gaining insights about disease biology and developing potential new treatments and interventions, especially in underserved areas such as multiple long-term conditions and rare diseases.
“It is essential to quickly move such interventions forward to the right patients, at the right doses, durations and combinations.”
Leading the world in innovative trial design
A key area of focus are clinical trials aimed at identifying the minimum ‘intensity’ – such as duration, frequency, or dose required – for a drug to be effective. For instance, finding the lowest effective dose of a chemotherapy drug could help make cancer treatment gentler for patients by reducing side effects.
The MRC CoRE team will be led by Professor Max Parmar will build on the team’s past work which created the highly innovative ‘multi-arm multi-stage’ platform clinical trials. These designs have revolutionised clinical trials to be more flexible, able to add or remove new drugs for testing over time, depending on results and new breakthroughs.
The leadership group will include researchers from the University College London, London School of Hygiene & Tropical Medicine, University of Cambridge, University of Edinburgh, University of Birmingham, and Newcastle University.
Professor Max Parmar, Director of the MRC CoRE in Clinical Trial Innovation, said: “Basic science is rapidly producing more understanding of biology and consequently many new interventions to help us in a range of diseases – both by industry and academic routes. Clinical trials are the way in which we evaluate all these new treatments. However, they are too slow and costly meaning it takes some 20 years to get a new invention from the laboratory into routine clinical practice at a cost of some £2 billion. Our goal with this CoRE is to substantially reduce this time so that patients can benefit much sooner from new treatments and also bring the costs of testing new treatments down.”
Professor Lucy Chappell, Chief Scientific Adviser at the Department of Health and Social Care and Chief Executive Officer of the NIHR, said: “Success for this Centre will be having efficient adaptive trials becoming part of the mainstream, in the range of approaches to carrying out clinical trials. With increasingly complex interventions being developed for our diverse population, we’re excited for the UK to be taking a leadership role in innovative trial design and look forward to seeing effective and more targeted treatment regimes being evaluated at pace and informed by novel methodology approaches.”
BHP members the Royal Orthopaedic Hospital NHS Foundation Trust and Aston University have come together with the Brazilian Aeronautics Institute of Technology (ITA) to found Biomedical Technologies for Regenerative Orthopaedics (BioTROCS) – a group aiming to advance research in the development, characterisation, and pre-clinical and clinical evaluation of novel biomaterials for bone regeneration and bone cancer applications.
ITA, Aston University and the Royal Orthopaedic Hospital have already been collaborating for several years to explore the use of gallium in treating bone cancer patients, and the formalisation of this alliance will make it easier for the three organisations to secure funding to further this ground-breaking research.
Dr Lucas Souza, Dubrowsky Regenerative Medicine Laboratory Manager at the Royal Orthopaedic Hospital, commented: “Collaboration is the core principle for groundbreaking research and solving real-world problems requires a multidisciplinary approach. BioTROCS is the officialisation of a long-term international collaboration between Brazil- and UK-based physicists, chemists, biologists and clinical researchers that has already made significant contributions to the advancement of technologies for the treatment of bone disorders such as critical-sized bone defects and bone tumours.
“This new phase represents the first step to establishing a strategic partnership that aims to facilitate the flow of researchers, materials, and data between participating institutions to foster an even richer research environment to accelerate discoveries in the field of biomaterials for bone regeneration and bone cancer.”
The new research group has successfully secured funding to further the group’s development of an injectable paste for use in bone cancer surgeries. The funding includes a PhD scholarship in Brazil, with the student also coming to Aston University for a 12-month placement.
Professor Dr Joao Lopes, Aeronautics Institute of Brazil, added: “The formalisation of the BioTROCS group is a key step in strengthening international scientific cooperation and represents a strategic opportunity to expand our research efforts in cutting-edge therapies for bone regeneration and bone cancer treatment. This partnership between institutions in Brazil and the UK not only enhances the development of novel biomaterials and advanced therapies, but also significantly increases our ability to secure funding from agencies that offer exclusive calls for international collaborative projects. In addition to enabling the exchange of researchers and knowledge, BioTROCS fosters a more dynamic innovation ecosystem that supports the development of high-impact clinical and technological solutions.”
Professor Richard Martin, Aston University, commented: “Aston University and the Royal Orthopaedic Hospital have successfully collaborated for five years in this area of research and the formation of an international research group will help drive forward the use of biomaterials for bone regeneration and bone cancer.
“This area of research has huge potential – for example in September 2024, our tests found that bioactive glasses doped with gallium have a 99% success rate of eliminating cancerous cells and can even regenerate diseased bones. My team at Aston University is looking forward to hosting the new PhD researcher who will help further advance our research.”
The first participant has been treated in an early-phase clinical trial investigating whether a new medical device, Carbalive, can slow disease progression and improve outcomes for patients with a rare liver disease called primary sclerosing cholangitis (PSC). The trial, known as the CATCH trial, marks the first time this device will be studied in humans with PSC-IBD.
The new clinical trial involves several BHP partners – it’s being coordinated by researchers from the University of Birmingham and the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, and clinicians at University Hospitals Birmingham (UHB) NHS Foundation Trust.
PSC affects around 3500-4000 people in the UK, including both adults and children. In PSC, the body’s immune system attacks itself, causing inflammation and scarring of the bile ducts – the small tubes that carry bile (a digestive fluid produced by the liver) to the gallbladder and small intestine. This leads to reduced or blocked bile flow, and over time, liver damage.
In around 80% of people with PSC, the body also attacks the bowel, which can lead to inflammatory bowel disease (IBD), a devastating disease that affects the lining of the gut, leading to severe gut inflammation, bleeding and diarrhoea.
There is currently no cure or medication to improve survival, and liver transplantation remains the only life-saving option for PSC.
The exact cause of PSC is not known, but research has shown that gut inflammation, that is also a key component of IBD, is a key trigger for the disease. Removing harmful substances and restoring the disturbed gut microbiome reduces gut inflammation, which may help slow its progression.
Carbalive (also called YAQ001) is a medical device created by Yaqrit – a company that develops life-saving treatments for patients with advanced liver disease. This device is made up of tiny carbon beads with lots of different sized pores to absorb toxins that would otherwise return to the liver.
In pre-clinical studies, animals with cholestatic disease (a condition where bile flow from the liver is impaired) showed improvements in liver function and signs of disease activity after treatment with Carbalive. Early studies in people with cirrhosis have also shown the device to be safe and effective in restoring the gut microbiome and reducing inflammation.
Palak Trivedi, Principal Investigator of the study, Consultant Hepatologist and Clinician Scientist at UHB, and Professor of Cholestatic and Immune-mediated Liver Disease at the University of Birmingham, said: “PSC-IBD is a progressive condition, and with no approved treatments, it can ultimately lead to liver failure.
“This trial is an important step in exploring the potential of Carbalive to slow the progression of this disease and improve patient outcomes. By funding this trial, and this innovation, LifeArc offers hope to patients and their families through a promising new approach.”
First participant in the trial
Nick Haynes, from Nottingham, is the first participant to take part in the trial and began his treatment this week.
Nick said: “I was diagnosed with PSC a couple of years ago, and as there aren’t many treatment options available currently, that really attracted me to taking part in this trial. I think it comes with many benefits – you hope the medicine will lead to some kind of improvement, but it’s also very reassuring to be part of enhanced screening. It’s about looking to the future too, and being part of something that could advance medicine and treatment options for people with PSC feels really positive. I really hope it becomes a viable treatment for patients in the future.”
Twelve patients with PSC-IBD will receive Carbalive orally for twelve weeks, and the data collected will assess whether the treatment improves bile flow and reduces inflammation.
The trial has been made possible through funding from LifeArc, a not-for-profit organisation supporting research into rare diseases.
Troels Jordansen, Yaqrit’s Chief Executive Officer said: “This is a great opportunity for Yaqrit to help patients with PSC-IBD while remaining highly focused on the treatment of late-stage liver disease.
“In YAQ001, the company has developed a treatment that addresses toxicities and inflammation that are common in advanced liver disease but also apparent in a broader spectrum of conditions.”
Sam Barrell, CEO of LifeArc, said: “For the 3.5 million people in the UK living with rare diseases, access to treatment is a huge challenge – 95% of conditions have none. That must change. World-first trials, like the CATCH Trial, are part of the solution, which is why LifeArc funded it through our Pathfinder Programme. We have an opportunity to make the UK the go-to place for innovative trials like this, but to realise this ambition we need to transform how we support rare disease research, making a difference for rare disease patients much faster.”
CATCH is the latest clinical trial delivered through the NIHR Birmingham Biomedical Research Centre, a partnership between the University of Birmingham and University Hospitals Birmingham NHS Trust, which focuses on inflammatory disease research. Collaborative research from the NIHR Birmingham BRC has already seen nearly 1,000 clinical trials initiated and has informed UK clinical guidelines.
