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Midlands-Wales Advanced Therapy Treatment Centre part of £17.9m network renewal

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

The Advanced Therapy Treatment Centre network includes the Midlands-Wales Advanced Therapy Treatment Centre, jointly delivered by BHP founding members the University of Birmingham and University Hospitals Birmingham.

The National Institute for Health and Care Research (NIHR), Innovate UK, the Advanced Therapy Treatment Centre Network and the Cell and Gene Therapy Catapult (CGT Catapult) have announced a £17.9 million strategic initiative to keep the UK as a location of choice for advanced therapy research and advanced therapy medicinal product (ATMP) clinical trials.

The initiative will provide a further four years of funding for the Advanced Therapy Treatment Centre Network (ATTC Network) which is currently composed of three centres: Innovate Manchester Advanced Therapy Centre Hub; Midlands-Wales Advanced Therapy Treatment Centre; and the Northern Alliance Advanced Therapies Treatment Centre.

The Midlands-Wales centre has multiple sites across England and Wales, with the Birmingham hub being jointly delivered by BHP founding members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, directed by Professor Philip Newsome from the University’s Institute of Immunology and Immunotherapy. Its aim has been to enable UK advanced therapy companies to reach the clinical market, whilst simultaneously building clinical capacity and capability regionally to deliver these breakthrough therapies to patients. It brings together a wide range of specialists in advanced therapy manufacturing including academic and commercial partners, logistics companies, specialists in clinical trial delivery and teams focussed on IT solutions and health economics.

Professor Philip Newsome, Director of the Midlands and Wales Advanced Therapy Treatment Centre and national clinical lead, commented: “This funding will accelerate the delivery of advanced therapy trials across the Midlands, Wales and beyond. It is an exciting time for patients, researchers and industry as new therapies are trialled and enter routine clinical care.”

The UK is a world leader in ATMP clinical research with 175 ongoing trials being carried out here, and with 9% of global ATMP trials having representation in the UK. Many more products are in development and further action is needed to ensure that the NHS is able to bring advanced therapies to patients at scale across the UK.

Through this further funding, and in close collaboration with NIHR infrastructure and the devolved equivalents, the ATTC network aims to build on its work on advanced therapy clinical trial readiness to ensure the UK maintains its position as a globally attractive location for clinical research.

Health Minister Andrew Stephenson said: “This investment reaffirms the UK’s position as a global leader in clinical research. It will help roll out revolutionary medical products more quickly, potentially treating the root cause of disorders and diseases like Alzheimer’s and cancer. Harnessing technological and digital innovations is one of our primary focuses under the first ever NHS Long Term Workforce Plan, enabling new and advanced ways of working.”

Dr Stella Peace, Executive Director for the Healthy Living and Agriculture Domain at Innovate UK, said: “From our initial investment to now overseeing the delivery of the new four-year programme, our goal is to ensure the UK maintains its global leadership in clinical research. Our commitment to fostering innovation and scientific advancements is crucial for sustaining this leadership. This drives medical breakthroughs, as well as strengthening the UK economy by attracting investments, generating high-skilled jobs, and positioning us at the forefront of transformative healthcare discoveries.”

Professor Marian Knight, Scientific Director for NIHR Infrastructure, commented: “The NIHR is committed to ensuring that the UK provides a research environment to enable rapid assessment of new advanced therapies with the potential to transform health and care. Partnerships such as these, linked with existing NIHR research infrastructure, will help ensure that the UK public is able to benefit from these ground-breaking new treatments.”

Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, added: “Advanced therapies have the potential to transform healthcare, providing a range of new, lifechanging treatments to patients. Thanks to far-sighted investments, like this commitment by NIHR and the on-going support of Innovate UK, the UK is recognised globally as a pioneer in advanced therapies. With the continued great work of the ATTC network, we hope to further build the reputation of the UK.”

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LIBERATE heart attack trial treats first patient

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

The first patient has been treated in the LIBERATE clinical study to evaluate glenzocimab efficacy in myocardial infarction, which involves BHP members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust (UHB).

In 2022, the University  signed a partnership agreement with Acticor Biotech to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE.

Having obtained full regulatory approval in August 2023, two clinical research sites, the Queen Elizabeth Hospital in Birmingham – part of UHB – and the Northern General Hospital in Sheffield, are involved in the study. The Queen Elizabeth Hospital opened to recruitment on 24th January 2024. It is expected that the Northern General Hospital in Sheffield will also open to recruitment by the end of February 2024.

The LIBERATE study, a randomiSed, double-blind Phase 2b trial, will enrol over 200 patients diagnosed with ST-elevation myocardial infarction (STEMI) and scheduled for percutaneous coronary intervention. The primary objective of the study is to evaluate both the safety and efficacy of glenzocimab at a dosage of 1000 mg compared to a placebo, specifically focusing on the reduction of myocardial infarct size at Day 90 post-treatment.

Professor Jon Townend, Chief Investigator of the trial who works across BHP members the University of Birmingham and UHB as Consultant Cardiologist and Honorary Professor of Cardiology, said: “We have entered the operational phase of the trial, and I extend my gratitude to the entire team in Birmingham and Sheffield for their outstanding efforts in managing patient recruitment in these critical emergency care settings, as well as for gathering qualitative data for subsequent analysis.”

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 is the first time worldwide that this class of medication has been investigated in patients with heart attacks, after showing great promise in patients with stroke. We are grateful to our patients for helping us in our mission to find new treatments that may help to reduce the damage done by heart attacks.”

Professor Robert Storey, Professor of Cardiology at the University of Sheffield and Honorary Consultant Cardiologist and Director of the Cardiovascular Research Unit at Northern General Hospital, said: “This study is exploring the potential of glenzocimab in reducing the type of blood clotting responsible for heart damage during heart attacks. This exciting collaboration with University of Birmingham and Acticor Biotech holds the potential to bring significant benefit to people suffering from a heart attack.”

Adeline Meilhoc, Head of Global Clinical Development of Acticor Biotech said: “We are delighted to witness the operational start of the study, and we reiterate our complete confidence in our partners as crucial contributors of its success. Acticor Biotech is dedicated to advancing treatments for the acute phase of thrombotic diseases. Glenzocimab application in ST-segment elevation myocardial infarction (STEMI) represents a significant focal point for Acticor Biotech’s commitment to medical advancement.”

New treatment combination may improve outcomes for children with rare cancers

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

Children who develop neuroblastomas, a rare form of cancer which develops in nerve cells, may benefit from receiving certain anti-tumour drugs as well as chemotherapy, a new trial has found.

The results of the BEACON trial conducted by the Cancer Research UK Clinical Trials Unit (CRCTU) at BHP founder-member the University of Birmingham found that combining anti-angiogenic drugs, which block tumours from forming blood vessels, alongside various chemotherapy drugs led to more young people seeing their tumours shrinking, from 18% in the control group to 26% among those on Bevacizumab.

The findings have been published in the Journal of Clinical Oncology. The trial saw 160 young people aged 1-21, from 43 hospitals in 11 European countries, randomised with half receiving the anti-angiogenic drug called Bevacizumab on top of conventional therapy. The group who received Bevacizumab had an increase in the likelihood of responding to treatment, from 18% among those who only had the established therapy to 26% for those with the additional drug. Patients who received Bevacizumab additionally had better one year progression-free survival rates.

The trial constituted one of many collaborations between the University of Birmingham and European expert groups SIOPEN (International Society of Paediatric Oncology European Neuroblastoma) and ITCC (Innovative therapies for children with cancer).

Simon Gates, Professor of Biostatistics and Clinical Trials at the University of Birmingham and senior lead author of the paper said: “These are very exciting results that hopefully get us closer to finding treatments for children who develop neuroblastomas. Currently, the outcomes are really poor for children who get this horrible cancer and so even seemingly small increases in the chance that a patient is going to be able to shrink their tumours is significant.

“We are delighted that the BEACON trial has helped to shape treatment for children with relapsed and refractory neuroblastoma going forward.”

Dr Lucas Moreno, Head of Paediatric Haematology and Oncology at Vall d’Hebron University Hospital, Barcelona, Spain and Chief Investigator for the study said: “BEACON was a hypothesis-generating trial that has served to identify active regimens that are now being further investigated. We are delighted that the data generated has been incorporated into the current UK Clinical Practice Guidelines and Bevacizumab is incorporated into standard treatment for relapsed neuroblastoma.”

Stem cell therapy for heart attack patients trialled at UHB

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

A stem cell therapy trial at BHP founder-member University Hospitals Birmingham is having a life-changing effect on heart attack patients, with scans showing almost complete restoration of heart muscle function just weeks after the procedure. 

After a heart attack, around 30% of patients are left with severely damaged and weakened hearts which can, over time, lead to life-threatening heart failure, as the heart is unable to pump the blood around the body properly. The trial therapy aims to prevent this heart failure by regenerating the damaged muscle.

Developed by biotechnology company CellProthera, the therapy involves the application of a person’s own stem cells directly into their heart, through the femoral artery in the leg. The patient’s heart activity is then monitored for six months – at 1, 3 and 6 months – using echocardiography and magnetic resonance imaging (MRI).

66 year old Kim Smith is one of four patients recruited to the trial at UHB and was randomly allocated to the experimental arm of the study, meaning that she received the therapy as treatment following her heart attack. Just two weeks after receiving the therapy, Kim’s heart function had returned to almost normal (55%).

Kim said: “I now feel as though I can actually do what I used to do before. When I had the heart attack, I was worried that I was going to end up being stuck at home all day, but since having the stem cell therapy, psychologically and physically, I just feel so much better.

“I’m so grateful to have had this treatment, and I do hope that the research that they are doing goes forward because I think a lot of people would benefit. That was my reason for doing it in the first place – even if it does nothing for me, it could help someone else.”

So far, approximately 50 patients from the UK and France have been recruited to the trial, known as the EXCELLENT (Expanded Cell Endocardial Transplantation) study. The research is currently in its final phase, with results expected later this year.

Dr Sohail Khan, Consultant Interventional Cardiologist and Lead Investigator at UHB for the EXCELLENT study, said: “What we have seen so far is that actually the stem cells do seem to have a dramatic effect in terms of improving heart muscle function.

“Currently, there are few clinical options available that repair and regenerate heart tissue following a heart attack. As a result, the only option for many patients that have suffered a heart attack and developed advanced heart failure, is a fully invasive heart transplant. This is a very serious procedure for the patient, and very costly for society.

“The development of a cell therapy to regenerate cardiac tissue will be transformative for a considerable number of patients globally. A minimally invasive, cell therapy, that uses a patient’s own stem cells, could also considerably reduce treatment costs.”

Matthieu de Kalbermatten, CEO at CellProthera, said: “Bringing the therapy to market as a minimally invasive therapy is vital to tackle, from the root, the harmful effects of heart attacks and improve quality of so many lives.

“The impressive progress of the CellProthera EXCELLENT trial is a testament to the work of our team and our stakeholders. All of the trial sites in the UK and France are committed to admitting and treating the final patients as quickly as possible. In 2024, we will look to start the phase III trial, where we will be recruiting patients from across Europe, with the aim of potential future market authorisation and bringing this vital treatment to all patients.”

NIHR awards £4m to Birmingham Clinical Research Facility to enhance the delivery of research

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

The Birmingham NIHR Clinical Research Facility (CRF) has been awarded £4 million from the National Institute for Health and Care Research (NIHR).

This funding is part of a total investment of £96 million that has been awarded to NHS organisations across England, to enhance the delivery of research through improving research facilities for patients across the NHS, helping teams to find new ways to prevent and treat diseases.

The Birmingham NIHR CRF is a collaboration between three BHP members – University Hospitals Birmingham NHS Foundation Trust (UHB), Birmingham Women’s and Children’s NHS Foundation Trust (BWC) and the University of Birmingham (UoB).

In Birmingham, new equipment will enable the delivery of innovative health technology services, including a range of cell and gene therapies requiring specialist pharmacy facilities. For example, onsite isolators will support preparation within the research facilities, speeding up the delivery of CAR-T trials for patients with haematology (blood) cancers, as well as trials into cancer vaccines for patients with a variety of solid tumour cancers.

The funding will also provide new laboratory equipment, essential for storing samples from patients recruited to metabolic research studies. This will support researchers with ground breaking work in the prevention, treatment and management of metabolic disease for adults and children across Birmingham.

The bid was led by Jo Gray, NIHR Birmingham Clinical Research Facility Clinical Manager, who said: “This successful bid for equipment and upgrades to our facility is fantastic and will make such a difference to patients and research teams across all partner sites.

“We have ambitious plans in place to upgrade existing equipment, as well as increase our ability to support new research across the sites. New equipment will include a paediatric ‘peapod’, which measures body composition and growth in premature born infants, and biosafety cabinets, which provide an enclosed ventilated space for drug preparation.

“Our portfolio of gastrointestinal (GI) and respiratory studies will also be able to grow with the addition of new endoscopy equipment. One of the key GI trials to benefit will be the INCEPTION clinic for patients with Inflammatory Bowel Disease (IBD). This trial aims to improve diagnosis and prognosis, and make more informed decisions on IBD treatment through biomarker discovery and implementation, by understanding more about how different microbiomes affect gut and oral immune responses.”

Professor Lorraine Harper, NIHR Birmingham Clinical Research Facility Programme Director, added: “We are tremendously proud that our hospitals have been selected for this award from the NIHR to improve the delivery of research in our local population. The award, which builds on existing clinical-academic collaborations facilitated by Birmingham Health Partners, will benefit our adult and paediatric patients, improving their access to new therapies and treatments, which can potentially be life-changing.”

Dr. Jan Idkowiak, NIHR Birmingham Clinical Research Facility Director (BWC), said: “This is very exciting. This award allows us to expand our ability to deliver cutting-edge clinical research beyond the Children’s Hospital, as it will enable us to include pregnant women and their children at the Women’s Hospital. This will be a huge benefit for our patients and will offer great opportunities to develop new therapies.”  

Professor Philip Newsome, Director of the NIHR Birmingham Biomedical Research Centre (BRC), commented: “This is fantastic news for both the CRF and for the organisations that work with them, like the Birmingham BRC. The CRF has been a key partner in delivering many of our experimental research studies, and we collaborate closely on our training, patient and public involvement, and equality, diversity and inclusion programmes too. We are looking forward to continuing working together to deliver patient benefit.”

Cannabinoid-based drug trial for brain tumours launches in Birmingham

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

A major UK clinical trial of an oral spray containing cannabinoids to treat recurrent glioblastoma has opened in the UK. Funded by The Brain Tumour Charity and coordinated by the Cancer Research UK Clinical Trials Unit at BHP founder-member the University of Birmingham, the three-year phase II trial  will investigate whether combining nabiximols and chemotherapy can help extend the lives of people diagnosed with recurrent glioblastoma.

Anyone interested in this study, which is called ARISTOCRAT, should speak to their medical team first to ensure they are eligible to participate.

It will recruit more than 230 glioblastoma patients at 14 NHS hospitals across England, Scotland and Wales in 2023 including Birmingham, Bristol, Cambridge, Cardiff, Edinburgh, Glasgow, London, Liverpool (Wirral), Manchester, Nottingham, Oxford and Southampton.

Professor Pamela Kearns, Director of the Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham, which is co-ordinating the trial, said:

“ARISTOCRAT represents a significant step in our journey towards finding safe and effective treatments for the most aggressive brain tumours. By testing innovative combinations of drugs we hope to improve the outcome for this challenging disease.

“We’re immensely proud to be able to bring this trial to patients with the support of the Brain Tumour Charity and thanks to the generosity of all those who gave to the crowdfunding campaign.”

Glioblastoma is the most aggressive form of brain cancer with an average survival of less than 10 months after recurrence.

In 2021, a phase I clinical trial in 27 patients found that nabiximols could be tolerated by patients in combination with chemotherapy, and has the potential to extend the lives of those with recurrent glioblastoma.

Should the trial prove successful, experts hope that nabiximols could represent a new, promising addition to NHS treatment for glioblastoma patients since temozolomide chemotherapy in 2007.

In August 2021, a fundraising appeal by The Brain Tumour Charity, backed by Olympic champion Tom Daley, raised the £450,000 needed for this phase II trial in just three months, and Jazz Pharmaceuticals has generously agreed to provide nabiximols and matched placebo free-of-charge to patients on the ARISTOCRAT trial.

Participants will self-administer nabiximols or a placebo spray and will undergo regular follow-ups with the clinical trial team, including blood tests and MRI scans. This will also be one of the first trials to integrate with The Brain Tumour Charity’s app BRIAN.

Principal Investigator, Professor Susan Short, Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds, said:

“We are very excited to open this trial here in Leeds and very much look forward to running the study which will tell us whether cannabinoid- based drugs could help treat the most aggressive form of brain tumour.

“The treatment of glioblastomas is extremely challenging. Even with surgery, radiotherapy and chemotherapy, nearly all of these brain tumours re-grow within a year, and unfortunately there are very few options for patients once this occurs.

“Cannabinoid-based drugs have well-described effects in the brain and there has been a lot of interest in their use across different cancers for a long time now. Glioblastomas have receptors to cannabinoids on their cell surface, and laboratory studies on glioblastoma cells have shown these drugs may slow tumour growth and work particularly well when used with temozolomide.

“We now have the opportunity to take these laboratory results, and those from the phase I trial and investigate whether this drug could help glioblastoma patients live longer in this first-of-a-kind randomised clinical trial.”

How can I take part in the trial?

Your treating oncologist will be aware of the study if it is open in your hospital or can refer you to a treating centre if necessary. Please speak to your treatment team about eligibility for the trial.

For more information visit the ARISTOCRAT web page on the Cancer Research UK Clinical Trials Unit website.