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Month: May 2021

Better treatment for miscarriage patients is also more cost effective

A new drug combination that is better at treating miscarriage is also more cost effective than current standard NHS treatment, finds a new study led by BHP founder-member the University of Birmingham and Tommy’s National Centre for Miscarriage Research.

A previous study by the same team and published in The Lancet in August last year, found that a combined drug treatment is more effective than the standard medication for women having miscarriages without symptoms – also known as missed, delayed or silent miscarriage.

Missed miscarriage occurs when a baby has died in the womb but the mother hasn’t had symptoms, such as bleeding or pain. Current hospital restrictions on surgery mean that many women face waiting for the miscarriage to happen by itself, which can take weeks and still might not happen, or being offered medication to speed the process along.

National guidelines recommend a treatment called misoprostol, which is successful in most cases – but some women wait anxiously for weeks, repeating the medication and eventually needing surgery.

The research published in The Lancet in August 2020 showed that misoprostol is more effective when combined with mifepristone, an anti-progesterone drug used to induce labour. The trial found that the combined drug treatment worked in 83% of cases, compared to 76% in the misoprostol and placebo group – and crucially, it reduced the need for surgery. One in four women (25%) given the placebo later needed an operation to complete the miscarriage, compared with less than one in five (18%) of those who had the new medication.

Now the team has carried out a further study to assess the cost-effectiveness of mifepristone and misoprostol combined compared with misoprostol alone for the medical management of a missed miscarriage.

The National Institute for Health Research (NIHR) funded study involved 711 women across 28 UK hospitals with a diagnosis of missed miscarriage in the first 14 weeks of pregnancy, who were randomly assigned to receive either mifepristone or a placebo drug followed by misoprostol two days later.

Published in the British Journal of Obstetrics and Gynaecology, the study found the new combined drug treatment was on average £182 cheaper for each successfully managed miscarriage than the current standard NHS medication.

As this is the largest ever study into the most effective medical treatment for missed miscarriage, and the results are so clear, researchers and campaigners are calling for guidance from the National Institute for Health and Care Excellence (NICE) to be updated in light of the newly published findings. In the meantime, Tommy’s experts encourage anyone diagnosed with missed miscarriage to ask their doctor about the combined drug treatment.

Senior author Tracy Roberts, Professor of Health Economics at the University of Birmingham, said: “Pregnancy loss causes heartbreak for millions of families, and it is crucial that we find better ways to care for everyone going through miscarriage. Our findings could have huge benefits if they’re translated into clinical practice, with better outcomes for patients and lower costs for care services.”

First author Dr Duby Okeke Ogwulu, of the University of Birmingham’s Institute of Applied Health Research, added: “We hope the NICE guidance will be updated in light of this new evidence, so that everyone who needs it has access to the most effective treatment.”

Tommy’s CEO Jane Brewin commented: “Besides the physical harm, miscarriage can have serious psychological consequences, which can be made worse by the trauma of a failed treatment forcing mothers to endure weeks of carrying a baby they know has died.

“One in four pregnancies ends in loss, and while our researchers work to understand how we can prevent this, it’s vital their latest findings are put into practice so that everyone going through miscarriage has the best possible care. Particularly given Covid-19 pressures on the NHS, our new study could be applied to make better use of precious resources, as well as reducing the toll miscarriage can take on parents.”

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, through direct impact on health services and lost productivity, but scientists expect the costs surpass £1 billion a year when factoring in longer-term physical and mental health impacts.

Claire Bromley, aged 32, from Sittingbourne in Kent, chose surgery when she had a miscarriage last year, as her previous experience when medication failed was so distressing.

Claire said: “The whole process took around 3 months and was extremely traumatic, so I hope this new drug will mean others don’t have to suffer like I did. I was told medication would take a few hours to work, but started bleeding and cramping in minutes, while stuck in hospital waiting for other prescriptions. Despite taking effect so fast, the medication didn’t work, so I was sent for surgery – and when that failed too, I had to take the pills again. With my second miscarriage, I chose surgery right away to avoid the risk of repeating such a long and painful treatment.”

Katy Allan, aged 43, from South Yorkshire has experienced multiple miscarriages and a range of treatment, initially having surgery that caused internal scarring and later choosing medication in the hope it would cause less damage.

Katy said: “The treatment for my third miscarriage was a four-month long nightmare, with several rounds of medication and hospital staff trying to physically remove the pregnancy while I was awake, ending in painful surgery; it was one of the most horrendous experiences of my life and I remain completely traumatised. I couldn’t move on physically or mentally because I was pregnant and not pregnant for months, with tests remaining positive and hormones still racing long after we heard those spine-shivering words of ‘I am so sorry but there is no heartbeat’. The long ordeal of treatment made miscarriage even harder so I hope this new research can help to prevent others from going through what I did.”

Revolutionising diagnosis and treatment of life-threatening post-partum haemorrhage

Post-partum haemorrhage (PPH) accounts for 27% of all maternal deaths worldwide, according to the World Health Organization (WHO). The burden of PPH disproportionately affects mothers from low- and middle-income countries, which account for 86% of all maternal deaths.

PPH is defined as blood loss from the genital tract of 500 ml or more within 24 hours of birth. PPH usually happens within a day of giving birth, but it can occur up to six weeks after a birth.

To find possible solutions to the terrible problem of PPH, researchers at BHP founder-member the University of Birmingham are conducting the E-MOTIVE trial based on the WHO ‘first response bundle’ in five countries: Kenya, Sri Lanka, South Africa, Tanzania and Nigeria.

Kristie-Marie Mammoliti, one of the lead researchers for the University of Birmingham explained the thinking behind the trial: “Surviving childbirth shouldn’t be a privilege; it should be the norm. Tragically this is not the case for so many women around the world. As PPH is the leading cause of maternal mortality globally, we are working together with our low and middle-income country partners to find solutions to stop women from bleeding to death after childbirth.”

Professor Hadiza Galadanci, from one of the University’s partners in Nigeria, commented: “One of the most frightening sights in Obstetrics is to see blood pouring from a woman after birth and to try all you can to stop it and you are not able to. If E-MOTIVE strategy is implemented in low- and middle-income countries, the light at the end of the tunnel to reducing maternal deaths due to PPH will be bright.”

The E-MOTIVE trial has the potential to revolutionise how medical institutions diagnose and treat PPH, and remove it from the list of life-threatening conditions facing pregnant women.

As we approach International Mother’s Day on Sunday 9 May, it is important for everyone to care and be aware of the risks that women across the world face when bringing life into the world, and how these risks can be reduced.

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

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

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.