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New heart attack drug trialled in Birmingham

Written by Louise Stanley on . Posted in Clinical trials.

A new partnership between BHP clinical-academic institutions and Acticor Biotech will see patients with heart attacks treated with glenzocimab, a promising new class of drug, for the first time.

The drug – which has potential to improve the long-term outcomes for heart attack patients – will be trialled in two UK acute care hospitals: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield.The trial will be run at the University of Birmingham with expert clinicians from the Institute of Cardiovascular Sciences and University Hospitals Birmingham NHS Foundation Trust, bringing together clinical trials expertise from two founding members of BHP.

The randomised, double-blind Phase 2b LIBERATE study will recruit more than 200 patients to test the tolerance and the efficacy of glenzocimab 1000 mg, versus placebo, to reduce heart damage following a myocardial infarction (MI), commonly known as a heart attack. Bringing together experience in running multi-site trials from the Clinical Trials Units and expertise in heart diseases, the team will see whether glenzocimab will reduce the amount of dead heart tissue in patients following an ST-segment elevation myocardial infarction (STEMI), the most serious type of heart attack.

Professor Jon Townend, Consultant Cardiologist at University Hospitals Birmingham, Honorary Professor of Cardiology in the Institute of Cardiovascular Sciences at the University of Birmingham, and Chief Investigator of the trial said: “We look forward to starting this exciting trial of a new drug for heart attacks which are still only too common.

“Although immediate opening of the blocked coronary artery by angioplasty in cases of heart attack is now routine, significant heart damage still occurs. Glenzocimab reduces clot formation and laboratory findings have been impressive.

“There are strong reasons to believe that this new drug may improve outcomes and this randomised blinded trial is the right way to test this theory.”

Dr Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, said: “This trial will help us establish whether glenzocimab is a safe and effective drug for preventing the kind of clotting that can lead to serious damage to the heart following a heart attack.

“We’re delighted to work with Acticor Biotech to see whether this new class of drug has the potential to improve the outcomes of our patients with heart attacks. While the immediate care provided for a heart attack is effective for improving patient survival, there is more we can do to prevent long-term damage to the heart.”

Gilles Avenard, Chief Executive Officer and founder of Acticor Biotech said: “Glenzocimab has already delivered very promising results in the treatment of acute ischemic stroke and we hope to confirm its therapeutics potential in another severe indication.

“We are proud of this Phase 2b study launch, which allows glenzocimab development programme extension to myocardial infarction. We would like to congratulate all the teams involved, the University of Birmingham particularly, sponsor of this study.”

Glenzocimab, a humanized monoclonal antibody (mAb) fragment directed against the platelet Glycoprotein VI (GPVI), was developed by Acticor Biotech for the treatment of cardiovascular emergencies, including stroke.

This new drug, currently being trialled for strokes, stops the functioning of platelets that cause abnormal clotting of blood. While platelet function is normally important to stop bleeding, this drug specifically targets only dangerous clotting inside damaged blood vessels called thrombosis that can cause strokes and heart attacks.

Single-stranded suture threads could prevent pregnancy infection complications, finds C-STICH trial

Written by Louise Stanley on . Posted in Clinical trials, Maternal health.

Women at risk of pregnancy loss who need a specialist surgical procedure are at a lower risk of infection if the procedure is carried out using a single-stranded suture thread, results from the C-STICH clinical trial found.

The trial was the largest of its type and is published in the Lancet. It involved more than 2,000 expectant mothers who needed a procedure called a cerclage, where a purse string suture is placed around the cervix (the neck of the womb) during pregnancy. Women were randomly allocated to have the surgical procedure performed using either a single-stranded thread or a braided thread.

Researchers tested whether there would be any difference in miscarriage or stillbirth, due to an increased risk of infection, from using a braided suture thread. The research, funded by the NIHR, demonstrated that single-stranded sutures could potentially improve outcomes for mothers at risk of preterm birth.

The team led by researchers from Birmingham Women’s and Children’s Hospitals (BWC) and the University of Birmingham – both founder-members of BHP – found that the mothers treated with single-stranded threads had no differences in pregnancy loss or preterm birth but reported fewer instances of infection and sepsis. This could have important implications for the health outcomes of mothers and babies who are treated with a cervical cerclage in their pregnancy.

Dr Vicky Hodgetts-Morton, NIHR Clinical Lecturer in Obstetrics at the University of Birmingham and Birmingham Women’s Hospital explained the implications of the trial results. Dr Hodgetts-Morton said:

“Preterm birth is a significant problem, complicating approximately one in ten pregnancies around the world. The consequences of preterm birth may be significant with some babies being born too early to survive, and those that survive are at increased risk of health complications. One cause for preterm birth is cervical insufficiency, occurring in 0.5% to 1% of pregnant women for which the placement of a vaginal cervical cerclage can be an effective treatment.

“Suture thread choice has the potential to improve how well a cerclage works in preventing miscarriage, stillbirth and preterm birth. Both single stranded and braided threads are commonly used to perform cerclages and our findings show no differences in pregnancy loss and preterm birth. The C-STICH trial results did show an increased risk of infections in labour and around the time of delivery with braided threads and this supported our hypothesis that a single stranded thread could reduce the risk of infection developing during the pregnancy.”

Mr Philip Toozs-Hobson, Chief Investigator of the C-STICH project and Consultant Gynaecologist at the Birmingham Women’s Hospital said:

“We are extremely grateful to all the women who trusted us by taking part in the study and also the dedication of the research teams at of the 72 maternity units who made the trial happen. Our aim, as ever, is to improve women’s experience in pregnancy through safer childbirth and to help the NHS achieve their target of reducing both pre-term birth and cerebral palsy. This work has added to our understanding relating to infection and sepsis.”

The study also highlighted that while single stranded suture threads led to better outcomes around infection, clinicians mentioned that such suture threads were subjectively more difficult to remove and more often required surgery to help remove under a general anaesthetic.

researcher in laboratory

Birmingham BRC receives £30m boost to improve treatment of inflammatory diseases

Written by Louise Stanley on . Posted in Birmingham Health Partners, Clinical trials, Early diagnosis and detection, Experimental medicine, Inflammation and chronic disease.

Increased funding for the renewed NIHR Birmingham Biomedical Research Centre will enable continuation of major developments around inflammatory diseases and new technologies and systems

The NIHR Birmingham Biomedical Research Centre (BRC) has been awarded more than £30 million in funding from the National Institute for Health and Care Research, a major funder of global health research and training, to support world-leading research into inflammation – including the development of new diagnostic tools and treatments for those with cancer, liver and heart disease, and many more illnesses.

The centre brings together multiple BHP members – including leading NHS providers led by the University Hospitals Birmingham NHS Foundation Trust and academic institutions led by the University of Birmingham – as well as other organisations working closely with charities and businesses. Its aim is to support research into inflammation which causes or worsens many common long-term illnesses including arthritis, liver disease and cancer.

This new investment represents an almost threefold increase in funding for the NIHR Birmingham BRC and will enable researchers to focus on eight areas of illness including heart disease, women’s health, and common complications from inflammation. Researchers will also be empowered to consider new tests and biomarkers for disease, health technologies including stem cells and gene therapy, patient experiences and data science.

Professor Phil Newsome, Director of the NIHR Birmingham BRC, said: “Inflammation plays a central role in many health conditions, with millions of people in the UK alone experiencing inflammatory diseases such as arthritis and bronchitis. This significant increase in funding will enable us to provide an outstanding environment for world-leading clinical research and allow us to make a step-change in our work tackling different forms of cancer, trialling new drugs for liver disease, and dealing with antimicrobial resistance.”

Patients will benefit from the increased funding thanks to the BRC’s collaborative research that has seen nearly 1,000 clinical trials and informed UK clinical guidelines.

Researchers will look at eight themes to continue to understand and help patients manage inflammation-based diseases including cancer, arthritis, and liver disease. The investment of the NIHR funding in biomedical research will enable clinicians, researchers, patients and supporters to find new treatments such as the development of new immunotherapies, which are types of cancer treatments to support the body to fight cancer.

Professor David Adams, Director of BHP, commented: “The investment from NIHR is hugely important for researchers working across the BRC partner institutions, to continue to tackle some of the critical health themes that affect our region. The funding will allow us to deliver new therapies and diagnostic tests for a range of chronic inflammatory diseases for which we currently have few effective treatments.”

Professor Lucy Chappell, Chief Executive of the NIHR, said: “Research by NIHR Biomedical Research Centres has led to a number of ground-breaking new treatments, such as new gene therapies for haemophilia and motor neurone disease, the world-first treatment for Creutzfeldt–Jakob disease, a nose-drop vaccine for whooping cough, and the first UK-wide study into the long-term impact of COVID-19.

“This latest round of funding recognises the strength of expertise underpinning health and care research across the country and gives our nation’s best researchers more opportunities to develop innovative new treatments for patients.”

The Birmingham Biomedical Research Centre is made up of the following BHP member organisations:

  • University Hospitals Birmingham NHS Foundation Trust
  • University of Birmingham
  • Sandwell and West Birmingham NHS Trust
  • Birmingham Women’s and Children’s NHS Foundation Trust
  • Aston University

Working closely with partners:

  • Birmingham Community Healthcare NHS Foundation Trust
  • Keele University
  • University of Oxford

Urine test for bladder cancer could replace thousands of invasive procedures each year

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Early diagnosis and detection.

Birmingham researchers funded by Cancer Research UK and liquid biopsy company Nonacus have developed a new urine test for bladder cancer, which could reduce the need for invasive and time-consuming procedures to diagnose the disease.

The test will use highly sensitive liquid biopsy technology developed by Nonacus in conjunction with  a panel of biomarkers developed and validated by Mr Rik Bryan and Dr Douglas Ward from the Bladder Cancer Research Centre at BHP founder-member the University of Birmingham, to detect the presence of bladder cancer by finding DNA from tumour cells present in the urine.

The biomarker panel, which consists of 443 genetic mutations that are common in bladder cancer has been validated in a deep sequencing study recently published in European Urology Oncology.

In this study, which was funded by Cancer Research UK and the Medical Research Council, the researchers used the test to analyse urine from 165 people with bladder cancer that had experienced haematuria (blood in the urine), and successfully detected the disease in 144 of them (87%).

The researchers also looked at using the test in 293 patients who had already been treated for bladder cancer and were being monitored for the cancer returning. In this setting, the test returned a higher proportion of false positive results compared to when used in the haematuria clinic (37.5% vs 15.2%), with 99 positive urine tests without a tumour being seen by cystoscopy on the same day. However, during their follow up monitoring, the patients who had those positive results had almost 3-times higher (11% vs 4%) rates of the cancer returning within 24 months indicating that the test could help detect recurrent disease before it is visible by cystoscopy (the camera inspection of the bladder). Further research is needed for the test to be used for surveillance.

Lead researcher Mr Richard Bryan said: “Even though cystoscopy is good at detecting bladder cancer, it’s invasive and time consuming for patients, so we need a better way to diagnose patients. In the future our test could be an easier way to get people with bladder cancer diagnosed faster, and could mean that tens of thousands of cystoscopies on healthy patients can be avoided each year.”

Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK said “These findings show that this urine test could help diagnose bladder cancer more easily. Early detection of cancer is key for improving patient outcomes and research like this could help identify the patients that need treatment soonest, while easing the pressures of diagnostic procedures on the NHS. We look forward to seeing how the test performs in the next clinical trial.”

The researchers are working in partnership with Nonacus, a provider of genetic testing products for precision medicine and liquid biopsy, to turn their approach into a clinical test for patients to be used within the NHS, and will start a clinical study funded by Cancer Research UK and involving over 3000 patients to evaluate just how powerful the test is at reducing the number of cystoscopies.

Each year, over 300,000 cystoscopies are carried out in England, however, around 80% of patients with haematuria who’ve had cystoscopy are found to have no cancers or abnormalities1,2.  The researchers believe that using the urine test in haematuria clinic could reduce the number of patients requiring a cystoscopy by at least 45%.

Civilians and military take part in study to improve concussion prognosis

Written by Louise Stanley on . Posted in Clinical trials.

A major UK study to identify new ways to accurately predict if patients will develop long-term complications as a consequence of concussion has been launched, led by experts at BHP founder-member the University of Birmingham and the Defence Medical Rehabilitation Centre, in collaboration with the Defence Medical Services.

With year one funded by the Ministry of Defence (£2m) and projected to run over eight years, the multi-faceted study will include a trial involving 400 civilians and 400 military personnel aged over 18 with a new diagnosis of concussion (also known as a mild traumatic brain injury or mTBI) which has resulted in them needing hospital treatment or rehabilitation.

At specific time intervals over two years, the participants will take part in nine different areas of research using a variety of medical techniques and assessments to establish if these can be used routinely by medics as ‘biomarkers’ to indicate prognosis and long term impact of concussion. Medical techniques and assessments being trialled include brain imaging and function, analysis of blood and saliva samples, and headache measures, as well as mental health, vision, balance, and cognitive performance.

mTBI is common and has been declared a major global public health problem, with 1.4 million hospital visits due to head injury annually in England and Wales – 85% of which are classified as mTBI. It is also estimated that up to 9.5% of UK military personnel with a combat role are diagnosed with mTBI annually.

The research will involve 20 University of Birmingham experts working across disciplines, including neurology, psychology, sports medicine, mathematics and academics within the University’s Centre for Human Brain Health, and will be coordinated by Birmingham Clinical Trials Unit. It will also be driven by experts at the Defence Medical Rehabilitation Centre Stanford Hall; Aston University, Imperial College London; University of Westminster; University of Nottingham; Royal Centre for Defence Medicine; and University Hospitals Coventry & Warwickshire.

Alex Sinclair, Professor of Neurology at the University of Birmingham and Chief Investigator of the project, called mTBI-Predict, explained: “Although classified as mild, and many recover, the consequences of concussion can be profound with many patients suffering long-term disability due to persistent headaches, fatigue, imbalance, memory disturbance, and poor mental health including post-traumatic stress disorder, while it can have a significant impact on the economy through loss of working hours and demand on the health system.

“Identifying those patients most at risk of these disabling consequences is not currently possible. There is therefore a pressing need to develop accurate, reproducible biomarkers of mTBI that are practical for use in a clinical setting and can predict long-term complications. Our programme of research will deliver a step change in the care of patients with mTBI, enabling a personalised medicine approach to target early intervention for those most in need but also identifying those with a good prognosis who can return rapidly to activities of daily living.”

Co-Chief Investigator, Air Vice-Marshall Rich Withnall QHS Director of Defence Healthcare, UK Ministry of Defence said: “I am delighted that the Defence Medical Services, including the Defence Medical Rehabilitation Centre at Stanford Hall, will be working hand-in-glove with class-leading civilian colleagues and the National Rehabilitation Centre Programme. I fully support this ground-breaking research which I am confident will lead to significant clinical innovation to benefit military and civilian patients, and have translational positive impact for sporting activities from grass-roots to elite levels.”

Peter McCabe, Chief Executive of Headway – the brain injury association, said: “We know that even a seemingly minor head injury can have a major impact on a person’s life – and often the lives of those closest to them. This is particularly the case if the brain injury goes undiagnosed or its effects are mistaken for other conditions. The frustration of not having an accurate diagnosis or receiving the right support can be compounded by the lack of a clear recovery pathway or timeline. We therefore welcome this study in the hope that it can advance our understanding of concussion and mTBI.”

 

New study explores unique approach to treat a rare liver disease

Written by Louise Stanley on . Posted in Clinical trials, Experimental medicine.

A UK research study looking into a new approach to treat primary sclerosing cholangitis (PSC), a rare disease where the body’s immune attacks its own liver, has been given the green light thanks to vital funding from LifeArc and the patient-led organisation PSC Support.

The FARGO trial, led by Dr Palak Trivedi at the University of Birmingham, will find out if a new treatment can slow PSC progression and improve quality of life for patients.

What is PSC?

PSC is a rare liver disease which affects around 3,600 people in the UK. People can develop the condition at any age, but most commonly those under the age of 40.

In PSC, the body’s immune system attacks the liver, causing inflammation and scarring of the bile ducts. This causes bile to stop flowing properly, and patients experience repeated infections, develop liver failure and, in some cases, cancer. In four out of five people, the body’s immune system will also attack the bowel, leading to inflammatory bowel disease (IBD) as well as liver disease. The combination of PSC and IBD can lead to around a third of all patients developing bowel cancer and patients require a colonoscopy every year to screen for it.

Currently, doctors treat PSC by managing symptoms only. We don’t fully understand what causes PSC, and there is no cure. A liver transplant is the only life-saving treatment. Although a very rare disease, PSC accounts for 1 in 10 of all liver transplants in the UK and is now the leading reason for liver transplantation in several European countries.

While it is life saving, liver transplantation is also risky and costly to the NHS. People who have had a transplant must take a cocktail of drugs to prevent their new liver being rejected. PSC can still return in around a third of people who have had a liver transplant.

Imbalance of gut microorganisms – and a new approach

We know that the microbes present in the gut of people with PSC are different to those in people without liver and bowel inflammation. This gut microbe imbalance is linked with many abnormal immune functions, which may drive development of the condition.

In the FARGO study, the research team will find out if taking stools containing natural microbes from the gut of healthy donors, refining it in a lab, and transferring it to the bowel of people with PSC, could reverse the imbalance of gut microorganisms. This treatment is called faecal microbiota transplantation, or FMT. Early research has also shown that it can treat IBD.

Bespoke clinical trial

The Birmingham team, together with teams at the Royal Free London, St Mark’s Hospital, Imperial College London, and Norfolk and Norwich University Hospitals NHS Foundation Trust, will carry out a clinical trial to test this new treatment approach. People with PSC taking part in the study will receive either FMT once a week for eight weeks, or placebo (an inactive FMT equivalent). Each group will continue to receive their usual routine standard of care for their IBD.

The teams will observe both groups for another 40 weeks. The team will then measure how successful the treatment has been in improving liver blood tests, reduce scarring of the liver, lessen the severity of their IBD, and improving symptoms and quality of life.

Dr Palak, who is leading the trial at the NIHR Birmingham Biomedical Research Centre, said: “I am delighted that LifeArc has chosen to support such a novel, bespoke and distinctive clinical trial, and to enable us to the necessary ground work needed to better understand how PSC develops and progresses.

“This study will really help us to understand which gut microbes are most important, and how this potential treatment could be scaled up to treat more people.

“Our study will lay the foundation for future work on a larger scale, with a view to making FMT available across the world.

“Should our trial show that FMT works well, PSC Support will be advocating for patients to access FMT as early as possible. We hope this means it will be making a difference to patients within five years after we’ve completed this work.”

LifeArc’s Dr Catriona Crombie said: “Our approach to funding is to work with others, to uncover the potential of promising research that could solve complex healthcare problems that patients face.”

She continued: “We’re delighted to be jointly funding this project with PSC Support, where Dr Trivedi’s team aim to reveal more information about PSC and help to translate this experimental treatment, from lab idea towards the clinic, where it could offer hope to patients with PSC.”

Martine Walmsley, Chair of Trustees at PSC Support, said: “Although we welcome clinical trials that test brand new drugs for PSC, progress is painfully slow. People with PSC don’t have the luxury of time and we must look at quicker medicine development routes.”