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

Written by Louise Stanley on . 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 Centre (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 . 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 . 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.”

Trial aims to prevent blindness in patients with neurological condition IIH

Written by Louise Stanley on . 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.

Birmingham’s brain tumour centre awarded Tessa Jowell Centre of Excellence status

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

The brain tumour centre at BHP founder-member University Hospitals Birmingham (UHB) has been recognised as a Tessa Jowell Centre of Excellence following rigorous expert-led assessments by the Tessa Jowell Brain Cancer Mission.

With more than 12,000 people diagnosed every year with a primary brain tumour in the UK[i], and 300 new patients seeking treatment at UHB, the award has been introduced to recognise hospitals for their excellence in patient care. It represents a step change in the neuro-oncology landscape across the UK.

UHB was measured on a range of criteria, including its excellent clinical practice and training opportunities; emphasis on patient quality of life; providing clinical trials and offering a high standard of research opportunities. Led by a committee of experts in the field and virtual site visits, the assessments were backed up by patient feedback about the care they received.

At least 88,000 British people are currently living with a brain tumour but over 5,000 people a year will lose their lives to it[ii]. The “Excellence” status provides reassurance about the availability of excellent care within the NHS and positive recognition for its staff at UHB who, despite the challenges of the Covid-19 pandemic, continue to go above and beyond for their patients. Due to the strain Covid-19 has placed on the NHS, UHB’s brain tumour centre now offers virtual clinics for patients.

Founded to design a new national strategy for brain tumours, the Tessa Jowell Brain Cancer Mission is committed to helping as many hospitals as possible achieve the “Excellence” status in the future. To achieve this, the mission is launching the Tessa Jowell Academy, a national platform allowing hospitals to share best-practice to improve their services, as well as one-year fellowships for doctors to further specialise in brain tumours.

Jess Mills, Co-Founder of the Tessa Jowell Brain Cancer Mission and Tessa’s daughter, said: “Mum’s mission throughout 50 years of her political life was to tackle systemic inequality. So, it was tragic whilst fitting, that her final campaign was a call to arms to create universal equality in access to excellence in cancer care throughout the NHS. It is with immeasurable pride that just 3 years later, the Tessa Jowell Brain Cancer Mission has begun the real-world translation of that vision into reality. 

“We are thrilled to have awarded University Hospitals Birmingham for its excellent ongoing work for patients and commitment to support other centres in reaching the same level of Excellence. Shockingly, the UK still has one of the worst cancer survival rates in Europe, but in time, the Tessa Jowell Centres will make the UK a global leader in the treatment and care of brain tumour patients. We have a long way to go until the cutting edge of science is delivered to every patient, but this is a huge and transformational first step.”

Colin Watts, Professor of Neurosurgery at BHP founder member the University of Birmingham and Honorary Consultant Neurosurgeon at UHB, said: “We are delighted that our model of patient-centred, consultant-led, research-orientated care for brain cancer patients has been recognised in this way. This award is a tribute to the whole multidisciplinary team who put patients at the centre of everything they do and take real pride in delivering best practice for everyone.

“It is a privilege to be to be  given this status from TJBCM partner organisations and we are very proud to affiliate ourselves with this recognition. We have worked hard as a team over the years to develop and improve patient care and will always strive to make a difference wherever possible. We will continue this process collaboratively by sharing and developing best practice within our service, externally and between other service providers for this cohort of patients.”

Cally Palmer, NHS England National Cancer Director, said: “This award is a fitting tribute to Tessa Jowell and her dedication to excellence in cancer care, as well as to all the NHS staff who have worked tirelessly throughout the pandemic to continue to provide life-saving cancer services, and it is great to see NHS hospitals across the country being recognised as centres of excellence. NHS services are open and ready to help those who need cancer care, and I encourage anyone who is experiencing any worrying symptoms to contact their GP immediately to improve chances of a successful recovery.”

Tessa Jowell Centres of Excellence:

      1. University Hospitals Birmingham
      2. Edinburgh Centre for Neuro-oncology
      3. King’s Health Partners of King’s College Hospital & Guy’s and St Thomas’s Hospitals in London
      4. Leeds teaching hospitals NHS Trust (Leeds General Infirmary and St James’s Hospital)
      5. Salford Royal Foundation Trust and The Christie (Manchester)
      6. Newcastle upon Tyne Hospitals NHS Foundation Trust
      7. Nottingham University Hospitals (NUH) NHS Trust
      8. St George’s University Hospital, Royal Marsden Hospital and Royal Surrey County Hospital
      9. University College London Hospitals NHS Foundation Trust

Over £700M is spent on cancer research in the UK every year, yet less than 2% of that is dedicated to brain tumours[iii]. The Mission will be supported by the All-Parliamentary Group on Brain Tumours chaired by Derek Thomas MP, to secure further support for NHS centres to enable more of them to achieve the “Excellence” status in the future. To kick-start additional monetary support, the Tessa Jowell Foundation, the charity set-up by Tessa’s family to lead the delivery of her legacy, has announced a fundraising appeal to raise £4M to enable the centres to excel after the network is launched.

[i] Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/brain-other-cns-and-intracranial-tumours (Data: 2015-2017, UK)

[ii] Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/brain-other-cns-and-intracranial-tumours#heading-Zero (Data: 2015–2017, UK). Accessed October 2020.

[iii] National Cancer Research Institute (NCRI) Cancer Research Database Data Package 2019

 

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New med-tech partnership to assess quality of life in clinical trials and care

Written by Louise Stanley on . Posted in Clinical trials, Health inequalities.

BHP founder-member the University of Birmingham has today announced a partnership with med-tech company Aparito to co-develop digital platforms to assess patient quality of life and symptoms in clinical trials and routine NHS care.

The partnership will see the configuration of Aparito’s flagship software platform Atom5™, and brings together international experts in patient-reported outcomes (PROs) methodology and input from patients and clinicians, with cutting-edge and innovative technology.

The aim of the partnership is to co-develop multiple digital PROs for use in a wide range of disease groups to assess treatment safety and effectiveness from the patient perspective and enhance the patient experience of clinical trials and routine care. These data will support patient care and provide evidence to inform regulators and policy makers such as the Medicines and Healthcare products Regulatory Agency (MHRA), and the National Institute for Health and Care Excellence (NICE).

Professor Melanie Calvert, National Institute for Health Research (NIHR) Senior Investigator and Professor of Outcomes Methodology at the University of Birmingham’s Centre for Patient-Reported Outcomes Research (CPROR), said: “It is essential that we capture information on the impact of disease and treatment on patient symptoms and quality of life.

“This information can help regulators decide if a treatment is safe and effective and answer important questions from patients such as ‘how will it make me feel?’

“We are delighted to be partnering with Aparito to use cutting edge methodology and technology to advance this area and benefit patients.”

Dr Elin Haf Davies, CEO of Aparito, which is based in Wrexham in the UK and Leiden in the Netherlands, said: “We are highly honoured to enter into this partnership with the CPROR at the University of Birmingham.

“Professor Melanie Calvert and her team are highly regarded and international leaders in PRO methodology. We very much look forward to expanding on this work to provide a digitalised and personalised solution, in 2021 and beyond.”

One of the projects is the new National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) ‘PRiORiTy’ (Patient Reported Outcomes Research in Trauma) study.

In this study, the team of experts at BHP founder-members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust will assess patient symptoms following traumatic brain injury to help tailor care to patient needs.

This is an important issue for patients, as explained b ypatient advocates involved in the design of the study, Luke and Jackie Flavell: “We feel it is really important for patients to report symptoms of traumatic brain injury as early as possible and doing this electronically would save valuable time and improve patient care. We are very much looking forward to working with CPROR on the PRiORiTy study.”

Daniel Lewi, Head of Business Development at Aparito, added: “Working with the team at University of Birmingham to provide a technology solution for PRiORiTy has highlighted how deeply clinicians care about the patient experience and how they can improve treatment within the patient cohort.

“Having such an approachable and knowledgeable team has allowed the University of Birmingham to detail very specifically how we can adapt our Aparito Atom5™ technology to really change a patient’s life and we cannot wait to work with the team again on future projects.”