Month: May 2023

BHP members join new Mission for mental health research

Written by Louise Stanley on 26/05/2023. Posted in Clinical trials, Early diagnosis and detection, Mental health.

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

Written by Louise Stanley on 17/05/2023. 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.

£2m study aims to improve early stage ovarian cancer diagnosis

Written by Louise Stanley on 15/05/2023. Posted in Cancer outcomes, Early diagnosis and detection.

A £2 million study will see an advanced test used at GP surgeries in the West Midlands to diagnose early-stage ovarian cancer – potentially saving thousands of lives a year.

The project involves BHP members Sandwell and West Birmingham (SWB) NHS Trust and the University of Birmingham collaborating with Walsall Healthcare NHS Trust (WHT) and primary care provider Modality, to offer a blood test called ROMA to patients experiencing symptoms of ovarian cancer.

Signs of the disease include bloating, stomach pain, needing to urinate more often and always feeling full.

If symptoms persist or are severe, frequent or out of the ordinary, women are urged to see their GP where – usually – a CA-125 blood test will be carried out, which has around a 50% detection rate of early-stage cancer.

However, the advanced ROMA test used during this trial at Modality-run GP services in Walsall, Sandwell and West Birmingham, will identify key markers of this particular disease at an earlier stage.

If a patient has tested positive, they will be referred to their local Trust to attend a new one stop clinic where they’ll see a consultant, undergo a specialist scan and then a further consultation where the results will be shared. They will be referred for further treatment if needed.

Speaking about the study, called SONATA (tranSforming Ovarian caNcer diAgnostic paThwAys), Sudha Sundar, Professor of Gynaecological Cancer at the University of Birmingham and Consultant Surgeon at SWB NHS Trust, said: “Ovarian cancer is rare and there is a need to increase the understanding and awareness of the symptoms associated with it among our population and GPs.

“We know that 90% of women diagnosed with ovarian cancer at stage one will survive, but this drops drastically to 15% if it is picked up during stage four.

“Research conducted with my team at the University of Birmingham found out that the ROMA test is significantly better than current tests (CA125 and ultrasound) used in both pre and postmenopausal women*.

“A previous study had found that the ROMA test detects up to 20% more early-stage cancers than the current test which only picks up 50% of early-stage cancers**. We are putting this research into practice by carrying out this trial.”

“With Modality-run GP surgeries trialling the ROMA test we will be able to establish if it is acceptable to patients and clinicians. By testing many samples across two large laboratories, we will be able to confirm whether the ROMA test has a higher chance of detecting this cancer earlier than the current CA-125 blood test used and whether implementing this across the NHS will be cost-effective.”

Leading on the project, Dr Aamena Salar, medical director for Modality Partnership Community Services, said: ‘Our aspiration is to transform the care of ovarian cancer by earlier detection and better outcomes for our patients.”

Nina Jhita, programme director at Modality, added: “This is true innovation; we (primary care) are delighted to collaborate with key system partners across the West Midlands to really make a difference to the lives of women while demonstrating how this solution can be scaled across the UK.”

The final part of the study will see 41,000 primary care samples sent to the Black Country Pathology Service and South Tyne and Wear laboratories to accurately establish whether using the ROMA test rather than CA125 will be cost effective for the NHS. The results from the study, funded by the NHS Cancer Programme and the Small Business Research Initiative, will be analysed and used to change the way this cancer is diagnosed in the future.

Professor Sundar added: “It’s an exciting study which is a great example of integrated working between all the organisations involved. We are looking forward to finding out the results so that we can change the way this cancer is detected in the future and drastically improve survival rates.”

*Abstract published in July 2023: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011964.pub2/full
**Further information can be found here: https://pubmed.ncbi.nlm.nih.gov/27540691/

nurse discusses bowel disease with a patient. plastic model of bowel in foreground.

UHB launches mRNA cancer vaccine trial for colorectal cancer

Written by Louise Stanley on 09/05/2023. Posted in Cancer outcomes, Clinical trials, Experimental medicine.

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

Written by Louise Stanley on 05/05/2023. Posted in Cancer outcomes, Clinical trials.

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.”

Second city’s strategic health alliance welcomes mental health trust as new member

Written by Louise Stanley on 02/05/2023. Posted in Birmingham Health Partners, Mental health.

Birmingham Health Partners has underlined its commitment to delivering research that enhances health and wellbeing by welcoming Birmingham and Solihull Mental Health NHS Foundation Trust (BSMHFT) as its fifth NHS member.

BSMHFT was founded in 2003 and provides a wide range of inpatient, community and specialist mental health services – including early intervention and rehabilitation – and is one of the largest mental health trusts in the country with a workforce of around 4,000 across 50 sites. With a national and international reputation for research, BSMHFT maintains strong academic links with a number of prestigious institutions including BHP members the University of Birmingham and Aston University, and its portfolio includes studies focused on dementia, eating disorders, addictions, mood disorders and perinatal mental health.

Roisin Fallon Williams, Chief Executive of BSMHFT, commented: “My colleagues and I welcome the opportunities that membership of Birmingham Health Partners will provide to both our service users and our Trust, through the benefits of continued research and innovation in provision of mental health care in our region. We believe passionately that research is complementary to service delivery, rather than surplus to it, and BHP’s ethos of embedding research into all stages of clinical care is a perfect fit with our own culture.”

Professor David Adams, Director of BHP, commented: “BHP’s mission is to work collaboratively to ensure our community are ‘born well, live well, and die well’. The importance of mental health and wellbeing to this vision cannot be overstated, and neither can the intrinsic link between physical and mental health be overlooked. BSMHFT is already a long-term partner in many of the mental health studies and trials run across BHP, and so their formal inclusion in our partnership is a natural extension of our collaborations to date.”

BHP’s membership now comprises: the University of Birmingham; Aston University; Birmingham and Solihull Mental Health NHS Foundation Trust; Birmingham Women’s and Children’s NHS Foundation Trust; the Royal Orthopaedic Hospital NHS Foundation Trust; Sandwell and West Birmingham Hospitals NHS Trust; University Hospitals Birmingham NHS Foundation Trust; and the West Midlands Academic Health Science Network.