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

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.”

Birmingham’s world-leading cancer trials unit gets £10m boost

A new £10m grant from Cancer Research UK will ensure that adults and children with cancer continue to benefit from world-class clinical trials led by the University of Birmingham.

The news has been hailed as a ‘major boost for patients’ by both clinicians and cancer survivors.

The Cancer Research UK Clinical Trials Unit (CRCTU) at BHP founder-member the University of Birmingham has already achieved significant progress in the treatment of cancer in the UK and internationally, including establishing new standards of treatment for the rare bone and soft tissue cancer, Ewing Sarcoma.

Scientists at the centre have also transformed the management of some types of prostate cancer and introduced treatment innovations for patients with blood cancers.

The new grant will allow researchers working on more than 100 national and international trials to continue developing safe and effective treatments as well as new tests for cancer over the next five years.

Professor Pamela Kearns, Director of the University of Birmingham-based CRCTU unit and children’s cancer expert, said:

“The renewal of funding for cancer trials in Birmingham is a major boost for our research here and we are delighted to continue working with research teams and patients to find new solutions in cancer care. Our clinical research enables us to translate discoveries from the lab and accelerate the improvement of cancer treatments, giving more patients the best chance of beating their disease.

“As a paediatric oncologist, I am particularly pleased this funding will allow our unique Children’s Cancer Trials Unit at Birmingham to continue to design and run clinical trials to improve the care of children with cancer.

“For example, with support from Cancer Research UK, we are leading International trials for children and young people with difficult to treat cancers like FaR-RMS; a trial testing innovative new treatments for rhabdomyosarcoma and the BEACON 2 trial, testing a range of new combinations of therapies for children and young people with a type of childhood cancer called neuroblastoma, at a stage where they have failed to respond well to standard treatments.”

The Birmingham CRCTU will combine strengths in innovative clinical trial methods with outstanding scientific and clinical expertise nationally and internationally to deliver new clinical trials, across all age groups over the next five years. The CRCTU will work alongside the Birmingham Experimental Cancer Medicine Centre, which is also funded by Cancer Research UK and the National Institute for Health and Care Research on trials to tackle more complex types of cancer and for cancers of unmet need.

Professor David Adams, Head of the College of Medical and Dental Sciences and Pro-Vice-Chancellor at the University of Birmingham said:

“The CRCTU is a jewel in the crown of our research portfolio across the University and I am delighted that with this latest funding we will continue to conduct internationally leading research to find better treatments and tests for cancer.

“Together with the ongoing funding for our Experimental Cancer Medicines Centre, the University is ideally placed to continue advances in cancer research which has a hugely significant role in society today. With unprecedented challenges for our NHS and after the effect that the pandemic has had on waiting lists and access to care, we need more than ever to have quick, effective and safe care for cancer.”

The team coordinates ground-breaking clinical trials across the UK and internationally, as well as regionally through Birmingham Health Partners (BHP) – a strategic alliance between seven higher education and health institutions including the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Birmingham Women’s and Children’s NHS Foundation Trust.

Improving outcomes – Francesca’s story

Cancer survivor Francesca Williams was one of 640 patients across Europe to benefit from a trial led by the Birmingham centre that has significantly improved outcomes for children and adults with Ewing Sarcoma.

Diagnosed with a tumour in her rib bone just weeks after her 27th birthday in July 2017, Francesca had 15 sessions of chemotherapy and five weeks of radiotherapy back-to-back over ten months. This was followed by major surgery at Heartlands Hospital in April 2018 to remove the remainder of her tumour and rebuild her chest wall using muscle from her back.

Despite going through medically induced menopause and having no time to store any eggs for fertility treatment, Francesca is expecting her first baby in July.

“I feel so lucky to have been part of the trial,” said Francesca, a 32-year-old English teacher who now lives in Austria.

“The worst thing for me was thinking I wouldn’t be able to have children so to find out I was pregnant last year was incredible. I’m really excited about becoming a mum.”

The European-wide trial EE2012, run by the University of Birmingham’s Cancer Research Clinical Trials Unit, tested the standard chemotherapy treatment plan against a new experimental treatment plan in children and adult patients from ten European countries.

The trial – a shorter treatment than the previous standard – found that six per cent more patients were cancer-free after three years, with fewer toxic side-effects. Results were so conclusive that the trial finished early in 2019 and the new treatment adopted as standard across Europe.

“I was very dubious about the trial to begin with but I’m so glad my dad persuaded me to go for it,” said Francesca. “I had no sickness from the chemotherapy so it’s great to hear that the treatment is now being offered as standard. That’s why I feel so passionately about supporting research. Without improvements like this I wouldn’t be here now.

“It’s such a deadly cancer and it is so aggressive, there isn’t the biggest window of opportunity for treatment. It affects a lot of young adults and children who can lose limbs if it’s found in an arm or a leg, but treatment can be successful if it’s caught early enough.”

BHP members join new Mission for mental health research

BHP members the University of Birmingham, Birmingham Women’s and Children’s NHS Foundation Trust and Birmingham & Solihull Mental Health NHS Foundation Trust, are part of the Government’s new Mental Health Mission – designed to develop radical new treatments for mental health conditions.

The £42.7M investment into research aims to improve the speed and accuracy of diagnosis and increase the use of new technologies, as well as novel and targeted treatment approaches for those with mental illnesses – including young people at Forward Thinking Birmingham (FTB), the city’s unique 0-25s Youth Mental Health Service.

The Mission will be delivered through the National Institute for Health and Care Research (NIHR) Mental Health Translational Research Collaboration, a UK wide network of leading investigators specialising in mental health research.

In Birmingham, £9.9 million in funding will enable the establishment of the Midlands Translational Research Centre of Excellence, co-led by the Universityof Birmingham with Birmingham Women’s and Children’s Hospitals and Birmingham & Solihull Mental Health NHS Foundation Trust, with reach across the Midlands through the five years’ funding.

Research will focus on increasing recruitment to new studies to test and validate treatments in early psychosis, depression and children and young people. We will work with people with lived experience to comprehensively understand the best way to test novel treatments. There are also plans to train and support a network of new researchers, partners, NHS staff and young people in the Midlands.

Professor Rachel Upthegrove, Professor of Psychiatry and Youth Mental Health at the University of Birmingham and Mental Health Research and Development Lead at Birmingham Women’s and Children’s NHS Foundation Trust, said: “We’re delighted that the Government is making such a significant investment in mental health research. This funding will allow us to increase and lead large-scale early intervention trials aimed at delaying or preventing the onset of severe mental illness, and its impact, with evidence-based treatments and support.

“The Centre will put research where we need it most, focusing on young, superdiverse, and deprived populations, which may be unfairly missing out on access to research.”

Teams at the Research Centre will work with individuals with lived experience to understand the best way to test treatments. There are also plans to train and support a network of new researchers, partners, NHS staff and young people in the Midlands.  

Building on the priority healthcare missions launched in November 2022 as part of the Life Sciences Vision, the Mental Health Mission will promote collaboration across different sectors to bolster research and attract further investment from industry and research organisations.

Nationally, the Mental Health Mission will be chaired by Kathryn Abel and Husseini Manji. In a joint statement, they said: “We are delighted to be working together to make the new Mental Health Mission a truly revolutionary force behind mental health research. We want the Mission to create tangible differences to the lives of patients, both in the UK and internationally. Between us, we bring a wealth of experience in mental health research and innovation, and a commitment to genuine collaboration with patients, industry and healthcare staff.

“Bringing together the public sector, patients and industry as equal partners, the Mission will work with the Office for Life Sciences and the National Institute for Health and Care Research (NIHR) to support the NHS and NIHR to capitalise on its size and scope, and on the depth of its data resources. Alongside additional investment in mental health research and infrastructure, the Mission will foster a step change in the way we think about mental health, mental illness and its treatment. This will support development of the critically needed treatments across the spectrum of mental illness.

“We want the UK to be the most attractive place to conduct robust, high impact mental health research, ensuring people have access to the best, and newest, treatments. We are confident that the Mission will be unique in its ability to convene and challenge national partners to make this happen.”


Cannabinoid-based drug trial for brain tumours launches in Birmingham

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. 

UHB launches mRNA cancer vaccine trial for colorectal cancer

BHP founder-members University Hospitals Birmingham NHS Foundation Trust (UHB) has become the UK’s first site to launch the BioNTech Messenger RNA (mRNA) cancer vaccines trial which aims to recruit 10,000 people across the UK.

Launching within the NIHR Clinical Research Facility (CRF) at Queen Elizabeth Hospital Birmingham, mRNA vaccines are one of the most exciting experimental developments to emerge from the COVID-19 pandemic – with strong indications that they could become powerful anti-cancer treatments.

Traditionally, vaccines use dead or weakened viruses to stimulate the immune system into recognising or creating harmless antibodies, so when exposed to the real virus, the body is better placed to fend off an overwhelming infection. mRNA is a genetic material that copies instructions found in DNA, using them to make proteins that carry out functions in the body.

Efficiency and speed are part of the appeal of mRNA vaccines. The manufacture of traditional inactivated virus vaccines takes months as scientists are required to grow these on a huge scale, inactivate the virus, and then formulate it to administer in the general population. mRNA vaccine manufacture only requires the right sequence of genetic instructions.

At UHB, this mRNA trial aims to recruit patients with high-risk stage II and stage III colorectal cancers where there is no standard of care treatment to offer the patient following surgery. Each mRNA vaccine delivered will be personalised to the individual patient.

Around 42,900 people are diagnosed with colorectal cancers in the UK each year. It is the 4th most common cancer in the UK. In Birmingham and Solihull alone, almost 700 people are diagnosed with a colorectal cancer each year.

Dr Victoria Kunene, Consultant Oncologist and Principal Investigator for the trial at UHB, said: “I am really very excited that we have been able to lead the way in setting up this arm of the trial, and am looking forward to being part of the wider vaccine program at UHB.

“We are proud to have an impressive team aptly capable of safely delivering these studies here in the West Midlands, and it is a real pleasure to be part of this transformational trial.”

Prof Simon Ball, Chief Medical Officer, said: “A diagnosis of cancer is devastating for patients and their families; this trial represents a monumental step forward in providing not just hope, but a real promise of delivering better outcomes for patients with colorectal cancer, for whom there is not always a standard of care treatment available following surgery.

“Our research teams, supported by the NIHR, have a proven, distinguished track record in delivering vital trials that make significant contributions to medical and scientific discovery with the patient at the very heart; we’re immensely proud to be able to play a strong part in this here in the West Midlands.”

Participants randomised to receive the study treatment will receive 15 treatments of over one year, followed up for at least 36 months. The treatment is, in essence, a personalised medicine for post-operative patients with high-risk stage II/III colorectal cancer, for whom there is no standard of care treatment and involves the development and testing of an individualised cancer treatment called RO7198457.

UHB is the first site open for this trial – a multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457, versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection.

‘Individualised’ means that the treatment is made individually for each participant according to their unique cancer. This is then tested for mutations which create a unique fingerprint. The goal of an individualised cancer treatment approach is to help train the immune system to recognise and attack cancer cells.

Participants who are randomised to the observation group will be followed up for at least 48 months and visit the research site every three months. Care is provided to ensure safety during trial participation, including an informed consenting process, regular follow up where biomarkers and all reported outcomes are collected and analysed.

Incurable blood cancer trial finds new drug better than current treatments

Patients with an incurable blood cancer – polycythaemia vera (PV) – may respond better to a new drug compared to conventional best treatment, a new clinical trial has found.

The rare cancer results in patients producing too many red blood cells and the drug, Ruxolitinib, has been found to be better at treating PV compared to the best currently available treatment. Researchers at BHP founder member the University of Birmingham – funded by Blood Cancer UK – looked at how well the drug worked in those who don’t respond well to the first line of treatment in a randomised phase-II clinical trial.

In this trial, dubbed MAJIC-PV, 39 different hospitals co-ordinated by Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU) recruited 180 people with PV. They compared ruxolitinib (a drug that targets JAK2 and is already approved for use in PV but not available in the UK) with currently available therapies. Ruxolitinib led to better control of the disease with normal blood counts and a reduced spleen size.

For the first time ever, using samples from the study, the researchers showed that both controlling the blood count and reducing mutated JAK2 by 50% led to fewer disease related events – and that those patients with reduction in JAK2 mutation lived longer, with lower risk of disease progression.

Professor Pamela Kearns, Director of the CRCTU at the University of Birmingham said: “Working on new treatments for incurable cancers is just the kind of thing that the Birmingham Cancer Research UK Clinical Trials Unit is about. I am really pleased that this important clinical trial has found that ruxolitinib has long-term clinical benefit for the ongoing treatment of patients with PV, and that further trials will be able to identify whether the drug can be used as an effective first line treatment.”

PV belongs to a group of conditions that affect the blood called myeloproliferative neoplasms (MPNs). Recently Tim Jonze from the Guardian and ex-radio one DJ David Hamilton have announced they have this form of blood cancer, raising awareness of this lesser-known disease.

The disease is caused by a mutation in a gene called JAK2 and can cause blood clots. Those living with the disease have a risk of a reduced life expectancy as well as development of more aggressive blood cancers including myelofibrosis and acute leukaemia.

One of the commonly used treatments is a drug called – hydroxycarbamide – but those whose cancer does not respond to this drug have a poor prognosis.

Professor Claire Harrison, consultant haematologist at Guy’s and St Thomas’ NHS Foundation Trust and the trial lead, said: “For some time we have wanted to be able to understand the long-term benefits of a drug such as ruxolitinib for patients with PV. This study shows several important messages about this therapy which will hopefully shortly be available for UK patients. These are that comprehensively controlling the blood count reduces disease related events, and that molecular monitoring of mutation levels may also begin to be important.

“Patient therapy is chosen on an individual basis but options have hitherto been limited for PV patients. We are now studying this drug for newly diagnosed patients in a world-first study MITHRIDATE. I would like to thank all the patients who volunteered to be part of this study, their families, UK research teams, Novartis which provided the drug and Blood Cancer UK which funded the trial infrastructure and the trial management team.

Dr Suzanne Rix, Research Funding Programme Manager at Blood Cancer UK, said: “Blood cancer is the fifth most common cause of cancer in the UK, affecting over a quarter of a million people. There is currently no cure for polycythaemia vera and there are a number of complications that can arise from it, so designing, developing and testing medicines to give patients the best outcome possible is vitally important.

“Blood Cancer UK is committed to funding excellent quality scientific research to ensure we deliver better treatments for blood cancer, faster. This trial is a great example of how collaboration between charities, academia, clinicians and pharmaceutical companies can deliver impactful results.

“Our heartfelt thanks go out to those who took part in the trial, without whom we wouldn’t have been able to collect this vital information and continue to improve the outcomes for people with blood cancer.”