Author: Louise Stanley

Bayer to invest in childhood cancer trial at the University of Birmingham

Written by Louise Stanley on 10/05/2021. Posted in Cancer outcomes, Clinical trials.

Significant funding from Bayer, a global enterprise with core competencies in the life science fields of healthcare and nutrition, is enabling the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU) to deliver a new study arm of an international clinical trial which aims to identify more effective treatments for a rare type of childhood cancer.

Rhabdomyosarcoma is a soft tissue cancer which usually forms in skeletal muscle tissue and hollow organs including the bladder and uterus. Despite survival rates for the first occurrence of disease increasing from 25% in 1970 to more than 70% today, around a third of patients will relapse at least once which further increases their risk of dying, as treatment options after relapse are currently limited and innovative new drugs for this disease have been lacking.

The funding will support evaluation of regorafenib, an oral cancer therapy from Bayer, in relapsed rhabdomyosarcoma patients, aiming to determine whether this drug combined with standard treatment can improve survival rates, reduce the chance of relapse and improve long-term quality of life for patients. The product from Bayer is already approved as a monotherapy across certain forms of colorectal cancer, gastrointestinal stromal tumours, and hepatocellular carcinoma, and will now be investigated in this rare paediatric indication. The study will also explore biomarkers to evaluate whether they can be used to predict relapse and improve prognosis. The new study arm is one part of the international multi-arm, multi-stage Frontline and Relapse RhabdoMyosarcoma (FaR-RMS) clinical trial, which is already underway at the University of Birmingham, funded by Cancer Research UK.

Dr. Scott Z. Fields, Head of Oncology Development at Bayer commented: “Bayer is committed to developing new cancer treatments for which there is a great medical need, such as for paediatric cancer patients. We are pleased to be a partner on this important study supported by academic experts at the University of Birmingham and the European Paediatric Soft-Tissue Sarcoma Group, and are looking forward to the next steps of this trial and the benefits it could bring in the future for patients.”

Professor Pamela Kearns, Director of the CRCTU at BHP founder member the University of Birmingham, explained: “This new partnership with Bayer highlights our world-leading strengths in paediatric cancers and the excellence of our industry trials work at the University of Birmingham, and further evidences our strengthening capabilities with the forthcoming Birmingham Health Innovation Campus and its Birmingham Precision Medicine Centr e (BPMC) Industry Trials Hub.

“Our internationally-leading expertise in complex clinical trial delivery will inform this trial throughout as we seek to validate more effective treatments to enable children with rhabdomyosarcoma to return to remission and lead longer, healthier lives.”

Life Sciences Minister Nadim Zahawi said: “Birmingham is poised to be one of the UK’s powerhouses for innovation and it’s why the government recently designated it a Life Sciences Opportunity Zone – helping to capitalise on its expertise and attract inward investment from leading pharmaceutical and life sciences businesses.

“Today’s multi-million funding from Bayer is evidence of this thriving innovation ecosystem in action, and will enable the University of Birmingham to carry out a ground-breaking clinical trial to help accelerate treatments for children with cancer and improve their quality of life, all while cementing the UK’s status a global leader in life sciences.”

Michelle Mitchell, chief executive of Cancer Research UK, said: “We know that despite more children and young people surviving cancer than ever before, there is more that needs to be done as cancer still represents the leading cause of death by disease for this age group.

“It’s fantastic to hear that Bayer is investing in the FaR-RMS trial to help improve the lives of children and young people with this kind of rare cancer. It’s a testament to the strength of charity-funded research to be able attract this kind of high-level investment to the UK, which helps fuel innovations required to bring much needed new treatments to patients.”

Professor Meriel Jenney, Deputy Medical Director at Cardiff and Vale University Health Board, is Chief Investigator of the Far-RMS trial. She commented: “We strongly welcome this partnership with Bayer. The FaR-RMS trial is designed to facilitate the efficient testing of new drug combinations for the highest risk patients with rhabdomyosarcoma across Europe and beyond, through its multi-arm, multistage approach. This exciting partnership is the first of what we hope may be several partnerships to bring targeted agents into the FaR-RMS trial. The focus on biomarkers alongside the clinical data will also help us to understand better which patients with rhabdomyosarcoma respond to treatment and to find new, smarter ways of assessing that response.”

Richard Torbett, Chief Executive of the ABPI said: “We are delighted to see Birmingham leading valuable research to find new cancer medicines for children, and industry investing in the West Midlands. Our work with Birmingham Health Partners is to connect industry with Birmingham’s extraordinary life sciences capabilities to tackle global health challenges, and today’s announcement is exactly what we want to see.

“Partnerships like this between academia, companies and the NHS lead to amazing breakthroughs which benefit people not just in the West Midlands but across the UK and the world.”

The BPMC Industry Trials Hub offers comprehensive design of trials which are conducted to industry standard as well as critical trial data, curated to provide a ‘fit for filing’ package which offers accelerated progress to clinical adoption. BPMC will be part of the Birmingham Health Innovation Campus – the only science park in the region dedicated to health and life sciences, creating opportunities for transformative collaborations between the NHS, academia and industry partners.

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University of Birmingham joins drug discovery collaboration with Evotec and Bristol Myers Squibb

Written by Louise Stanley on 06/05/2021. Posted in Clinical trials, Experimental medicine.

BHP founder-member the University of Birmingham is part of a new industry collaboration launched to accelerate drug discovery projects by fast-tracking research from lab to patient.

Birmingham is one of four universities selected by drug development company Evotec SE and global pharmaceutical company Bristol Myers Squibb to be part of the newly formed beLAB1407.

Evotec, together with Bristol-Myers Squibb Company (NYSE: BMY) launched beLAB1407, a new $20m academic BRIDGE to identify and advance novel and breakthrough drug discovery opportunities across therapeutic areas from the UK’s top-tier academic institutions. Through a unique combination of Evotec’s drug discovery and development platforms and early-stage therapeutic concepts from the Universities of Nottingham, Birmingham, Edinburgh and Dundee, beLAB1407 offers a unique route to the advancement of first-in-class therapeutics and the creation of spinout companies.

Evotec’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations provide an integrated fund and award framework to validate exciting academic projects in collaborations with Pharma and biotech with the goal to form new companies. Since implementing the first academic BRIDGE ‘LAB282’ in Oxford in November 2016, Evotec has continued to evolve similar collaborations with a variety of academic, Pharma and venture capital partners across Europe and North America.

Researchers from the University of Birmingham’s Colleges of Life & Environmental Sciences, Engineering & Physical Sciences and Medical & Dental Sciences work across all areas of drug discovery from target identification to clinical trials, and will have the opportunity to apply for funding from this project.

David Coleman, Director of Enterprise & Innovation, University of Birmingham Enterprise, commented: “Over the last few years, the University of Birmingham has identified a significant pipeline of early stage life science discoveries. The support and investment provided by Evotec and Bristol Myers Squibb through beLAB1407 provides a great opportunity to validate and develop some of these into important therapies for the future, and we’re very excited to be working with them.”

Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: “We are thrilled to launch beLAB1407 together with our partners at Bristol Myers Squibb with whom we’ve worked on a variety of projects over a period of many years. beLAB1407 provides researchers from the member institutions with a unique way to fast-track their projects, to validate them on our industrial-grade platform and have partnering options including company formations readily available to them.”

Dr Rupert Vessey, Executive Vice President and President, Research and Early Development at Bristol Myers Squibb commented: “This collaboration builds on our important connection to leading European universities. With beLAB1407, we are supporting UK-based universities that are exploring many interesting lines of scientific research and discovery. That research combined with Evotec’s proprietary data platforms has the potential to identify new and novel therapies for areas of unmet medical need.”

The name beLAB1407 alludes to the distance between Land’s End in the far southwest of Great Britain to its north-easternmost point near the village of John O’Groats in Scotland, which – if travelled by bike – adds up to 1,407 kilometres. To learn more about beLAB1407, visit www.belab1407.org.

Weight loss surgery significantly reduces brain pressure in patients with IIH

Written by Louise Stanley on 27/04/2021. Posted in Clinical trials, Inflammation and chronic disease.

Weight loss surgery is more effective than dieting to reduce brain pressure that can cause blindness in patients with a neurological condition, finds a study led by Birmingham Health Partners founder-members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust (UHB).

Idiopathic Intracranial Hypertension (IIH) is a debilitating condition that raises pressure in the brain and can lead to chronic headaches and even permanent sight loss. The illness, which often leaves patients with a reduced quality of life, predominately affects women aged 25 to 36 and weight gain is a major risk factor of developing IIH and relapses of the disease.

Weight loss has been shown to be an effective treatment, with a reduction in body weight of between three to 15% inducing disease remission. However, maintaining weight loss is notoriously difficult, as most patients regain weight over a two to five year period.

In the first clinical trial of its kind, the research team set out to analyse whether bariatric surgery or a 12-month community weight management intervention (delivered through WW) would be the most effective for reducing brain pressure in women with IIH.

The trial, supported by the National Institute for Health Research (NIHR), involved 66 women with IIH with an average age of 32 years and a body mass index (BMI) of 35 or more. Half underwent bariatric surgery, while the other half took part in WW. Brain pressure was measured by lumbar puncture at the start and after 12 and 24 months.

The results, published today in JAMA Neurology, showed that bariatric surgery was significantly more effective than community weight management, with those having had surgery seeing an average intracranial pressure reduction of 25% after 12 months.

The results also showed that the surgery group lost on average 23Kg, as compared to losing 2kg in the WW group at 12 months. This difference was greater at 24 months with 24% more weight lost in the surgery group as compared to WW. This was because the bariatric surgery group continued to lose more weight over time (28Kg from the start of the study to 2 years), whilst the community weight management group had regained weight lost and, on average, were only 1kg lighter than at the start of the study.

Senior author Alex Sinclair, Professor of Neurology at the University of Birmingham and Neurology lead of the Idiopathic Intracranial Hypertension Service at UHB, said: “A link between weight and IIH has long been observed but, until now, there has been no robust evidence that weight loss can reduce brain pressure.

“We have shown that weight loss achieved through bariatric surgery is significantly more therapeutic than community weight loss management interventions both in the short and longer term to treat IIH brain pressure.

“Whilst we recognise that bariatric surgery may not be an appropriate approach for all patients with IIH and increased weight, it is important to now have the evidence that a surgical approach can lead to significant sustained disease remission.”

First author Dr Susan Mollan, Director of Ophthalmic Research at UHB, added: “We hope that as a consequence of this research, current NHS and NICE guidance can change to include bariatric surgery as a treatment for women with IIH and a BMI greater than 35 when appropriate and in line with the patient’s best interests and wishes.

“Weight stigma is a major barrier to patient care in IIH. We also hope this research will prompt discussion and education around weight management to ensure this sensitive topic is approached with care and dignity.”

Co-author James Mitchell, Lecturer in Neurology at the University of Birmingham, added: “Weight regain is often driven by biology rather than willpower, and obesity is a chronic relapsing disease that requires lifelong treatment. Therefore, it’s essential that patients are given appropriate support to achieve weight loss and further work is done to ensure they have good access to weight management services.”

a pregnant woman in a patterned dress sits on the edge of a hospital bed. a female doctor is speaking to her, with hands clasped.

End the postcode lottery in miscarriage care and treatment, say researchers

Written by Louise Stanley on 27/04/2021. Posted in Health inequalities, Maternal health.

Leading experts at BHP founder-member the University of Birmingham and Tommy’s National Centre for Miscarriage Research are calling on the UK government to invest in early pregnancy units and recurrent miscarriage clinics to end the current care and treatment postcode lottery.

The calls come as the team has laid bare the devastating impact of miscarriage and sets out recommendations to improve treatment and care in a series of three articles published today in The Lancet.

Urgent changes should be made to NHS policy, which currently provides exploratory testing for underlying causes of miscarriage for women only after they have experienced three consecutive miscarriages.

The team says many of the risks related to a miscarriage are present even after one or two miscarriages, and appropriate care should be provided to all women who have experienced one or more miscarriages.

Miscarriage care must also go beyond current best practice to include long-term mental health support to those who need it, while high-risk groups should also be offered specialist help from pre-conception and throughout pregnancy, they say.

While the UK provides national statistics for losses such as stillbirth and neonatal death, it does not for miscarriage. The team is calling for the UK – and all countries globally – to routinely publish their national miscarriage statistics to provide a vital benchmark to improve from; accelerate further research; develop public health policy; and ultimately improve care and support for families.

Together, following analysis of systematic reviews; appraisal of existing guidelines; and a UK-wide conference of experts, the researchers have developed recommendations for healthcare practice grouped into three categories: diagnosis of miscarriage, prevention of miscarriage in women with early pregnancy bleeding, and management of miscarriage.

An estimated 23 million miscarriages occur every year worldwide – equating to 44 pregnancy losses each minute. Miscarriage (defined as the loss of a pregnancy before 24 weeks) costs the UK at least £471 million a year due to direct impact on health services and lost productivity. However, scientists expect costs surpass £1 billion per year when factoring in longer-term physical, reproductive and mental health impacts.

Women have a 15% risk of miscarriage, and the team’s review of existing research shows risk factors for miscarriage include older age in both males and females, previous miscarriages, smoking, alcohol, and stress levels.

While the link between age and miscarriage is well established, the review uncovered a significant risk to black women, with 40% higher miscarriage rates in this group than their white counterparts. The researchers say further investigation is needed to understand the reasons for this stark contrast, and they are exploring whether it could be related to other health issues that more commonly affect black women that can complicate pregnancy, such as fibroid conditions and autoimmune disorders.

While some risk factors can be controlled, such as alcohol consumption and smoking, many cannot. Therefore, the researchers say care and support must be targeted at these higher-risk groups in addition to nation-wide changes to ensure quality services are consistently available to all.

The consequences of miscarriage are both physical, such as bleeding or infection, and psychological. The team of Tommy’s and University of Birmingham researchers found profound psychological effects on both parents – miscarriage almost quadrupled the risk of suicide, doubled the risk of depression, and similarly raised the risk of anxiety. Previous studies from another team at Tommy’s National Centre for Miscarriage Research showed that one in five mothers and one in twelve partners experience long-term symptoms of post-traumatic stress after loss.

Senior research author Arri Coomarasamy, Professor of Gynaecology & Reproductive Medicine at the University of Birmingham and Director of Tommy’s National Centre for Miscarriage Research, said: “Despite the many advances in miscarriage research and care, we are really just at the beginning, with many more avenues to investigate – for example, we need to understand why there is a higher rate of miscarriage in black women and why miscarriage is associated with an increased future risk of premature birth.

“We don’t even know exactly how many miscarriages happen in the UK; without this data, the scale of the problem is hidden, and addressing it will not be prioritised.

“As we work to open the ‘black box’ of miscarriage in the hope of unpicking its causes and finding new therapies, the UK must change its approach to miscarriage care, not only to reduce the risk wherever possible but also to better support those who do tragically lose their babies.”

Tommy’s CEO Jane Brewin said: “The variation in quality and availability of miscarriage care across the UK can lead to life-long problems for families already enduring an unbearable experience; it shouldn’t matter who you are or where you live, and you shouldn’t have to endure repeated heart-breaking losses before you get the right help.

“Everyone should be given care and advice after each miscarriage to reduce the chance of it happening again, with specialist support for those most at risk. Mothers’ care must consider their long-term risks, especially in future pregnancies, and both parents must be offered mental health support.

“We know what to do and how to do it – now we need a commitment from the NHS to put the knowledge we have into practice everywhere. With national targets to reduce premature birth and stillbirth, it’s time to prioritise miscarriage too.”

Recommendations outlined in The Lancet papers include:

- Individualised care according to women’s and their partners’ needs and preferences.
- Early pregnancy services focused on providing an effective ultrasound service and miscarriage management pathway, including medical management and surgical management.
- Prescribing vaginal micronized progesterone for pregnant women with the dual risk factors of early pregnancy bleeding and a history of previous miscarriage.
- Training for clinical nurse specialists and doctors to deliver comprehensive miscarriage care in dedicated early pregnancy units.
- A defined and universally available minimum set of investigations and treatments to be offered to couples suffering recurrent miscarriages.
- Screening and care for mental health issues and future obstetric risks incorporated into the care pathway for couples with a history of recurrent miscarriage.
- Structured care using a ‘graded model’ where women are offered online healthcare advice and support, care in a nurse or midwife-led clinic, and care in a medical consultant-led clinic, according to clinical needs.

To find out more about the research, visit Tommy’s ‘Miscarriage Matters’ campaign, and sign a campaign petition stating mothers should not have to experience three miscarriages before they receive specialist care.

Birmingham Health Innovation Campus takes another step forward after planning permission granted

Written by Louise Stanley on 15/04/2021. Posted in Birmingham Health Partners.

Work is set to begin on the first phase of Birmingham Health Innovation Campus this Summer after planning permission was granted by Birmingham City Council.

The first phase will see the development of No.1 Birmingham Health Innovation Campus which will offer 133,000 sq ft of lab and office space purposely designed for health innovation and life sciences businesses, with a focus on those working in medtech, precision medicine, biopharma and digital healthcare.

The building will include the home of the University of Birmingham’s Precision Health Technologies Accelerator (PHTA), providing innovation and incubation spaces for businesses to engage with academics and clinicians, bringing together capabilities in diagnostics, data, clinical trials and medical technologies.

The Campus positions the West Midlands to capitalise on the UK’s emerging healthtech sector, which attracted £1.12bn in investment in 2020, according to the latest report by Tech Nation, and has already been designated a Life Science Opportunity Zone by the Department for Business, Energy and Industrial Strategy (BEIS). It has also been identified as part of the High Potential Opportunity for Data Driven Healthcare by the Department for International Trade (DIT).

Companies located at Birmingham Health Innovation Campus will benefit from high quality lab and office space, and access to a fully connected clinical trials translation ecosystem at the region’s NHS Trusts. The Campus will also offer a range of additional facilities including a cafe, indoor and outdoor event space, meeting rooms, cycle storage and car parking.

The 10-year masterplan will provide up to 657,000 sq ft of state-of-the-art space for the West Midlands’ life sciences sector, supporting the creation of over 10,000 new jobs and contributing £400m of GVA to the regional economy by 2030.

No.1 Birmingham Health Innovation Campus is being developed in accordance with Bruntwood SciTech’s ongoing commitments to sustainability. Targeting BREEAM ‘Excellent’, the building will incorporate a number of design measures to reduce carbon emissions, mitigate the effects of climate change and protect and enhance the local environment.

David Hardman, managing director, Bruntwood SciTech – Birmingham, said: “The response since announcing the development of Birmingham Health Innovation Campus, in partnership with the University of Birmingham, has been extremely positive. It’s clear that this is being seen as a real milestone in the evolution of the West Midlands as a health innovation and connected healthcare technologies powerhouse.

“The region has all the raw ingredients the sector needs – world-class universities, a number of specialist NHS Trusts, quality infrastructure and a growing cluster of SMEs – to support the journey from early R&D to manufacture and market adoption of new health products and services. The Campus will be the epicentre where all these come together and attract further inward investment to ensure the West Midlands has one of the country’s most exciting life sciences propositions for years to come.”

Professor Tim Jones, University of Birmingham Provost and Vice-Principal, commented: “With the UK beginning a cautious easing of Covid-19 restrictions, this announcement could not be more timely. The speed at which the University and our NHS partners were able to mobilise against the pandemic is indicative of our collaborative and innovative approach to life sciences and medical technologies – an approach which businesses working with us at Birmingham Health Innovation Campus will benefit greatly from.

“The development is set to play a major role in post-Covid economic recovery, bringing enhanced health, wealth and opportunity to the city and wider West Midlands on a scale rarely witnessed. We are greatly appreciative of the support the Campus has received from the City Council and look forward to progressing with construction.”

Birmingham Health Innovation Campus is being built in Selly Oak, in the heart of the University of Birmingham’s academic and clinical cluster with the first phase set to complete in 2023.

The development has received funding from Birmingham City Council to support the enablement of the site. The Precision Health Technologies Accelerator (PHTA) has received £11m from the Greater Birmingham and Solihull Local Enterprise Partnership (GBSLEP) through the Local Fund and the Government’s Getting Building Fund.

Chair of Greater Birmingham and Solihull Local Enterprise Partnership (GBSLEP), Tim Pile added: “GBSLEP views health and medical technologies as a driver for inclusive economic growth. Our investment of over £11 million into the PHTA reflects our commitment to ensure we create opportunities for businesses to collaborate with industry experts and scale up.

“Healthcare innovation has been under the spotlight over the last 12 months and Birmingham Health Innovation Campus will undoubtedly help address the health needs that have emerged throughout Covid-19. The PHTA, which we have funded, highlights the way in which GBSLEP works in partnership with universities, businesses and local authorities to target investments in sectors and projects that will elevate our region, create jobs and put us on the global stage as a leader in innovative health and medical technologies. I look forward to the work commencing on site this summer.”

Trial aims to prevent blindness in patients with neurological condition IIH

Written by Louise Stanley on 30/03/2021. Posted in Clinical trials, Inflammation and chronic disease.

A new clinical trial being led by two Birmingham Health Partners founder-members aims to identify the best surgical treatment option to prevent blindness in patients with a neurological condition.

Funded by almost £1.5 million from the National Institute for Health Research (NIHR), it is hoped the research will lead to changes in healthcare policy for the treatment of patients with Idiopathic intracranial hypertension (IIH).

Thus far, there is no known cause for the neurological condition, which increases intracranial pressure around the brain without the presence of tumour or disease. Common symptoms of IIH include debilitating headaches, visual loss, pulsatile tinnitus, and back and neck pain. If left untreated, the disorder can lead to blindness.

The condition is managed with weight loss and medication, however, in severe cases that present as an emergency with decreasing vision, surgery is needed to prevent blindness.

Currently two different types of surgeries – dural venous sinus stenting (stenting) and cerebrospinal fluid (CSF) shunting – are used to prevent blindness, however there have been no clinical trials to determine which is the best operation. The team will carry out a clinical trial involving up to 138 IIH patients with rapid vision deterioration to establish which of the surgical procedures is the best at saving vision; the safest with least complications; and the most cost effective.

The research, which has been developed in consultation with patient charity IIH UK, will be carried out by a team of BHP experts at the University of Birmingham, University Hospitals Birmingham (UHB), and at sites around the UK.

Alexandra Sinclair, Professor of Neurology at the University of Birmingham, Honorary Consultant Neurologist at UHB and Chief Investigator of the new research project, explained: “CFS shunting involves implanting a thin tube known as a shunt in the brain, which allows the excess cerebrospinal fluid flow to another part of the body, thus rapidly reducing brain pressure.

“However, within the first year of surgery many tubes become blocked or infected and stop working. This, and other complications, have a significant impact on patients’ lives and have important cost implications for the NHS.

“More recently, stenting has been used, which involves placing a small stent across a narrowing of certain blood vessels in the brain, which can improve blood flow and lower brain pressure.”

Philip White, Professor of Interventional and Diagnostic Neuroradiology at the University of Newcastle and Co-Investigator, added: “So far, studies have not provided high quality evidence to show that this procedure can prevent blindness when vision is rapidly declining. Additionally, we need to confirm procedural durability compared with the surgery, which may need to be repeated and establish its safety is at least comparable.”

Miss Susan Mollan, Director of Ophthalmic Research at UHB and Co-Investigator, added: “We hope that the results of our study will provide evidence that will influence NHS policy and will lead to improved care for IIH patients, ensuring they receive the best possible treatment to prevent them from losing their eyesight.”

Amanda Denton, IIH UK Trustee and Research Representative, said: “IIH UK is delighted that this important trial is being carried out. Identifying the best types of intervention is one of our members’ top ten research priorities. Many of our members have shunts and stents to prevent them losing their sight and research to find the most effective method with the least complications is vital to improve their quality of life.”

The trial, will see participants being allocated to CSF shunting or stenting, which will be decided at random by a computer. The main outcome of the trial to be evaluated will be preservation of vision. A number of key additional outcomes, including treatment-related complications, headache and patient reported quality of life, will also be assessed.

Dr Ben Wakerley, Consultant Neurologist at UHB and Co-Investigator, comments: “The impact of these interventions on headache and quality of life have been highlighted to be of key importance by patients.”

An economic evaluation will be performed, led by Professor Emma Frew, University of Birmingham Co-Investigator, to estimate the cost-effectiveness of shunting versus stenting. Participants will be asked to attend routine hospital check-up visits over a year. Their health would then be monitored through linked NHS database records for longer-term follow up at two years.