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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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Drug dosing technology to improve children’s cancer treatment

Written by Louise Stanley on . Posted in Cancer outcomes.

A new project has been launched in collaboration with BHP founder-member the University of Birmingham aimed at aiding more precise drug dosing in children with cancer.

Children receiving chemotherapy treatment each process the drugs differently, leading to inconsistencies in drug concentrations in the blood (known as drug exposure).

Patients may not receive enough of the drug or in some cases may experience side effects following anthracycline treatment, predominantly in the form of dose-related cardiotoxicity.

A multidisciplinary team of experts working on the project, called ChromaDose, will develop a diagnostic drug monitoring tool to aid dose optimisation, enabling children receiving anthracycline chemotherapy – a type of the drug most commonly used to treat childhood lymphomas and leukaemias – to benefit from a personalised approach to treatment.

The technology behind ChromaDose, which is being led by UCL, will enable clinicians to calculate the patient’s drug exposure. Nurses administering the chemotherapy drug would collect a few drops of blood at different times following administration. These samples are then inserted into the ChromaDose bedside device using an innovative cassette design.

The machine automatically measures the amount of medicine within each blood drop and identifies the patient’s pharmacokinetic response (movement of drugs into and around the body), allowing ChromaDose to calculate the patient’s drug exposure.

Co-lead Professor Pamela Kearns, of the University of Birmingham, explained: “In 2021, there are nearly half a million survivors of childhood cancer in Europe and two thirds live with long term side effects from their treatment.

“One way to improve the side effect profile of a drug is to be more precise in the dosing. ChromaDose has the potential to allow us to individualise the dose of chemotherapy drugs to maximise effect on the tumour while minimising the side effects.

“I am looking forward to working with the team to move ChromaDose into clinical practice as a substantial step towards personalised medicine for children with cancer.”

Overall project lead Dr Stefan Guldin, of UCL Chemical Engineering, further explained: “We have come a long way from the first experiments in the lab to this unique opportunity to bring our technology into the clinic. The team we have been able to assemble in ChromaDose makes me confident that we can achieve our ambitious goals.”

Academics currently have the individual components which have shown promise when operated manually in a laboratory. They will now work to integrate these elements into an automated companion monitoring tool that will be able to provide reliable results within 30 minutes from insertion of the sample.

“The challenge of developing a fully-automated in-vitro diagnostic device for biochemical analysis on the ward cannot be underestimated,” explained Dr Alaric Taylor, Innovation & Design Lead at Vesynta Ltd, a UCL start-up. “Safety, performance, user experience and regulatory compliance are all competing factors.

“However, I believe that working within the ChromaDose consortium, with input and support from each and every stakeholder, makes the delivery of this technology possible.”

Co- lead Professor Gareth Veal, of the University of Newcastle, commented: “We have made great strides over a number of years in providing a national therapeutic drug monitoring service to support dosing decisions being made for childhood cancer patients across the UK.

“The development of a point-of-care diagnostic device funded through the i4i project could have a real impact on utilising drug monitoring approaches as routine cancer patient care in the future.”

The research team are working with a diverse group of stakeholders including children, parents, nurses, doctors, educators, designers, scientists and engineers. The Young Persons Advisory Groups at Great Ormond Street Hospital and North England were actively involved in the project planning stage, with over 60 participants, and remain important collaborators throughout the project. Additionally, parents and wider families of children who have experienced cancer will contribute through the Paediatric Oncology Reference Team.

Stakeholder satisfaction and user scenarios analysis will aid the translation of the ChromaDose innovation into the NHS healthcare system. This work is supported by partners at the National Institute for Health Research (NIHR) funded London In-Vitro Diagnostic Co-operative at Imperial College London. The expert team will map pathways for clinical integration alongside early stage health economic analysis, ensuring patient benefit is delivered rapidly and cost-effectively.

The ChromaDose project is funded by an NIHR i4i Product Development Award, which provides £980,000 for a nationwide multi-disciplinary team to conduct intensive research and development over 30 months. As project capstone, the team will seek regulatory approval from the notified body for widespread adoption.

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

 

AI and advanced imaging could diagnose childhood brain tumours without biopsy

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

A study led by Birmingham Health Partners member organisations has found that combining advanced imaging and artificial intelligence techniques can accurately classify the characteristics of common types of childhood brain tumours – paving the way for more rapid non-invasive diagnosis.

Brain tumours in a particular part of the brain, called the posterior fossa, are the largest cause of death from cancer in children. There are three main types of tumour that occur in the posterior fossa, and being able to characterise them quickly and efficiently can be challenging without confirmation via a biopsy, which is invasive.

Now a new study, carried out in collaboration with researchers from WMG at the University of Warwick and published in Scientific Reports, has found tumour diagnostic classification can be improved by using an advanced and non-invasive imaging technique known as ‘diffusion weighted imaging’ in combination with machine learning (AI). This means that the tumour can be characterised and treated more efficiently.

Diffusion weighted imaging involves the use of specific advanced MRI sequences, as well as software that generates images from the resulting data which uses the diffusion of water molecules to generate contrast in MR image. Experts can then extract a ‘map’ which can be analysed to give more information about the tumour.

The study involved 117 patients at five primary treatment centres across the UK, with images taken using machines across 12 hospitals.  The images were analysed by both an experienced radiologist and an expert scientist in paediatric neuroimaging.  Analysis from the images were fed to AI algorithms to successfully discriminate the three most common types of paediatric posterior fossa brain tumours, non-invasively.

Professor Andrew Peet, NIHR Professor in Clinical Paediatric Oncology at BHP founder-members the University of Birmingham and Birmingham Women’s and Children’s NHS Foundation Trust, said: “When a child comes to hospital with symptoms that could mean they have a brain tumour, that initial scan is such a difficult time for the family and understandably they want answers as soon as possible.

“Here we have combined readily available scans with artificial intelligence to provide high levels of diagnostic accuracy that can start to give some answers.

“Previous studies using these techniques have largely been limited to single expert centres. Showing that they can work across such a large number of hospitals opens the door to many children benefitting from rapid non-invasive diagnosis of their brain tumour.

“These are very exciting times and we are working hard now to start making these artificial intelligence techniques widely available.”

Professor Theo Arvanitis, Director of the Institute of Digital Health at WMG, University of Warwick, and one of the authors of the study, added: “If this advanced imaging technique, combined with AI technology, can be routinely enrolled into hospitals it means that childhood brain tumours can be characterised and classified more efficiently, and in turn means that treatments can be pursued in a quicker manner with favourable outcomes for children suffering from the disease.”

The research was supported by Cancer Research UK, EPSRC Cancer Imaging Programme at the Children’s Cancer and Leukaemia Group, the Medical Research Council, National Institute for Health Research (NIHR), Children’s Research Fund, Poppyfields and Help Harry Help Others.