The deadline of the 20th September is fast approaching for entries to the United Kingdom Acquired Brain Injury Forum (UKABIF) Film Award 2019, sponsored by Cygnet Health Care.
The judging panel is looking for a three-minute, impactful, ‘punchy’ film that raises awareness of the benefits of neurorehabilitation after an ABI, with a specific focus on neurorehabilitation in hospital, and/or in the community, and/or in school, and/or in prison or in connection with sport.
Entries are welcome from everyone with an interest, or experience in ABI, including the rehabilitation multidisciplinary team, doctors in primary and secondary care, case managers, personal injury lawyers, social care workers, voluntary organisations, care providers and individuals with a brain injury, their families or carers, students and the general public. The Film Award is also open to UKABIF members and non-members.
Biogen has announced new results from the NURTURE study, adding data to the longest study of spinal muscular atrophy (SMA) in pre-symptomatic infants (n=25).
These data reported, after up to 45.1 months of analysis, continue to demonstrate efficacy and safety in patients treated pre-symptomatically with nusinersen in comparison to the natural history of this disease. These new data also showed that patients treated with nusinersen had continuous improvement in sitting and walking independently, with the overwhelming majority of patients achieving motor milestones in a normal timeframe.1
These data were presented at the Cure SMA Annual SMA Conference in Anaheim, CA (June 28-July 1, 2019) and the 5th Congress of the European Academy of Neurology (EAN) in Oslo, Norway (June 29-July 2, 2019). “These study results demonstrate the durable impact of pre-symptomatic, proactive treatment on transforming the natural course of this disease. We are seeing an extensive number of patients continually meeting child motor development milestones,” said Darryl De Vivo, M.D., Sidney Carter Professor of Neurology and Paediatrics, Columbia University Irving Medical Center in New York, New York. “Nusinersen is setting patients on a path toward survival, greater mobility and independence from the start of treatment, which is helping improve outcomes for patients of all ages.”
Results from NURTURE, an ongoing, Phase 2, open-label study of 25 pre-symptomatic patients with SMA (most likely to develop SMA Type 1 or 2) who received their first dose of nusinersen before six weeks old, demonstrated results not before seen in comparison to the natural history of SMA. As of March 20191:
100 percent were alive without a need for permanent ventilation.1
The median age of the study participants was nearly three years old. The majority of untreated patients with SMA Type 1 never reach their second birthday without permanent ventilation.1
100 percent of the infants were sitting independently, in comparison to the natural history of this disease where no patients with SMA Type 1 would be able to do so and patients with SMA Type 2 would need assistance.1
88 percent of the infants were walking independently with many of them doing so in the normal timeframe for a toddler. In the natural history of SMA, patients with SMA Type 1 or Type 2 are never able to walk independently.1
Patients were approaching the maximum mean score of 64 on the CHOP INTEND measure of motor function– 63.4 for patients with 3 SMN 2 copies (n=10) and 62.1 for those with 2 SMN 2 copies (n=15), demonstrating the impact of early treatment.1
Nusinersen demonstrated efficacy up to nearly 4 years, with participants continuing to make progress and showing no signs of loss of motor function.1
Nusinersen was well-tolerated with no new safety concerns identified after up to nearly 4 years of treatment.1
“A few years ago, SMA patients had no treatment options and faced significant care challenges,” said Kenneth Hobby, President of Cure SMA, a patient advocacy organisation dedicated to the treatment and cure of SMA. “However, the future of SMA has changed and especially with early treatment patients now have a chance to reach age appropriate developmental milestones. These new data demonstrate the impact where children are now walking independently at four years of age, when the usual lifespan, for those who are most severe, would be under two if untreated1. This study provides additional evidence on the maintenance of these improvements. It’s critical that research in SMA continues to support the generation of real-world evidence in patients of all ages so that we better understand the long-term implications of SMA and treatment across all types.”
Additional presentations at the two meetings highlighted results from the ongoing open-label SHINE extension study of children with infantile and later-onset SMA as well the CS2/CS12 analysis of older patients. Biogen also continues to explore the scientific value of phosphorylated neurofilament heavy chain (pNF-H) and presented new data on the ongoing evaluation of its potential as a biomarker in SMA.
Drug Science is implementing Project TWENTY21 with the goal of providing medical cannabis to UK patients who may benefit from it. In the first instance, the Pilot will be targeting the following patients and situations, specifically focusing on times in which alternative treatment has failed:
Chronic pain
PTSD, with a focus on the veteran community
Multiple sclerosis
Tourette’s syndrome
Prison populations as a harm reduction strategy
Cannabis use disorder and substance use disorder as a harm reduction strategy
To achieve this goal, Project TWENTY21 will develop a body of evidence using a real-world data registry which documents the efficacy, safety, QALY and patient reported outcomes in those prescribed medical cannabis.
This data will then be used to support applications to health authorities in the expectation that there will soon be a new regulatory system for medical cannabis in the UK.
Drug Science is in the final stages of appointing a clinician and management team for Project TWENTY21, led by current CEO David Badcock.
Drug Science Chair Prof David Nutt FMedSci said:
Cannabis was a medicine in the UK for over a century until 1971 when it was banned for political reasons. Since then hundreds of thousands of patients have been forced to break the law to get a treatment that most find preferable to their previous prescription medicines. Despite the UK making cannabis a medicine in November 2018 there have as yet been only a handful of prescriptions on the NHS. To rectify this impasse Drug Science has joined forces with the United Patients Alliance, leading academics and several medical cannabis producers to open up a treatment network for up to 20,000 patients. This will allow patients to get vital therapy without breaking the law. It will also provide a solid clinical database from which experience of and confidence in, medical cannabis prescribing will develop, providing a foundation for other medical prescribers to build on.
About Drug Science Founded in 2010 by Professor David Nutt following his removal from post as Chair of the Advisory Council on the Misuse of Drugs, Drug Science is the only completely independent, science-led drugs charity, uniquely bringing together leading drugs experts from a wide range of specialisms to carry out ground-breaking original research into drug harms and effects. Its highly cited papers on all aspects of drug effects and harms attract global coverage and considerable public interest. Drug Science reduces the harms of drugs to the public through providing objective information on drug effects, harms and potential medical uses to the public, professionals and decision makers. To learn more, please visit: http://www.drugscience.org.uk
About United Patients Alliance (UPA) Founded in 2014, the UPA is the UK’s first medical cannabis support group, run by patients, for patients; United Patients Alliance provide tireless advocacy, compassionate campaigning, and essential education, to safeguard the patients’ voice in advancing legal access to cannabis therapeutics. To learn more, please visit: http://www.upalliance.org
About Althea Group Holdings Limited (AGH:ASX) Althea is an Australian licensed producer, supplier and exporter of pharmaceutical grade medicinal cannabis and is listed publicly on the Australian Securities Exchange (ASX:AGH). Althea also offers a range of education, access and management services to support eligible patients and healthcare professionals in navigating medicinal cannabis treatment pathways. Althea currently operates within highly regulated medicinal cannabis markets including Australia and the United Kingdom, with plans to expand into emerging markets throughout Asia and Europe. To learn more, please visit: http://www.althea.life
About Alta-Flora Alta Flora’s mission is to improve health and wellbeing through our plant-based products and carefully selected technologies. Our world-class team brings together talent and expertise from science, engineering, medicine and commerce to bring our vision to fruition. We strive to manufacture according to the highest European standards and distribute our botanical products to patients around the world. To learn more, please visit: http://www.alta-flora.com/en/
About Cannuba Cannuba Holdings is a group of companies specialising in the investment, production, licensing and sale of high-quality medicinal Cannabis-based products distributed globally. Formed in 2018, Cannuba’s management team has combined their expertise and resources to create a unique integrated model: R&D, farming, processing and manufacturing. http://www.cannuba.com/
Under the auspices of CCI France International, an international trade and development organisation, and the patronage of the President of France, Emmanuel Macron, this prestigious French prize is awarded to recognise a company, across all technology sectors, that has developed a technological innovation which contributes to the development of economic relations between France, French companies, and the rest of the world.
“We are incredibly honored to have been named the recipient of this award, and would like to express our sincere appreciation to the CCI France International committee for this kind recognition of PathMaker’s progress in developing MyoRegulator®, our first-in-class, non-invasive device for the treatment of patients suffering from spasticity,” said Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker. “Building on the momentum we received last year from the French-American Business (FAB) Award for Startup of the Year from FACCNE, the 2019 CCI France International Trophy for Innovation is a testament to the work done by our team and collaborators in bringing this breakthrough device to patients.”
About PathMaker Neurosystems Inc. PathMaker Neurosystems is a clinical-stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with chronic neuromotor conditions. With offices in Boston (U.S.) and Paris (France), we are collaborating with world-class institutions including the Brain and Spine Institute (Institut du Cerveau et de la Moelle Epinière – ICM) at the Pitié-Salpêtrière Hospital in Paris to rapidly bring to market disruptive products for treating spasticity, paralysis and muscle weakness. In January 2019, we announced a collaboration and distribution agreement with WeHealth Digital Medicine to commercialise the MyoRegulator® device worldwide, excluding U.S. and Japan territories retained by PathMaker. More than 48 million patients in the U.S., Europe and China suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. At PathMaker, we are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions. For more information, please visit the company website at www.pmneuro.com.
Bial and Eisai have announced clinical practice data from the Euro-Esli study demonstrating clinical effectiveness of eslicarbazepine acetate, and that it is generally well tolerated as an adjunctive therapy in focal epilepsy patients with psychiatric comorbidities, including intellectual disability, compared with people with no psychiatric comorbidities.[1] The data, which add to the body of evidence on eslicarbazepine acetate as adjunctive therapy from Phase III studies,[2],[3],[4],[5] were published in Journal of the Neurological Sciences.[1]
Psychiatric comorbidities, including intellectual disability and depression, are common for adults who have epilepsy.[6],[7] Prevalence of psychiatric comorbidities may be twofold higher in adult patients with epilepsy compared to the general public, and up to a quarter of people diagnosed with epilepsy are estimated to have an intellectual disability.[6],[7] Psychiatric comorbidities can exacerbate the effects and increase the impact of epilepsy.[8] Furthermore, antiepileptic treatments can interfere with treatments for the psychiatric comorbidities, and thus adversely affect these psychiatric conditions. [9],[10] There are many considerations for treating this patient population, thereby complicating treatment choice.[10]
“The comorbidities of epilepsy represent a substantial burden for people with epilepsy. This data provides a significant insight into how eslicarbazepine acetate performs in a routine medical setting for these patients and the results are very encouraging, demonstrating eslicarbazepine acetate’s efficacy and tolerability as an adjunctive therapy in this sub-set of patients,”
Dr Colin Doherty, Consultant Neurologist, St James’s Hospital, Dublin, Ireland, and lead author of the Euro-Esli study.
This newly published data includes patient populations that are sometimes excluded from clinical trials, including those with psychiatric comorbidities, specific comorbidities of intellectual disability, or depression.[1],[11] Adverse events reported during this sub-cut of the Euro-Esli study are consistent with eslicarbazepine acetate’s safety profile established in Phase III studies.[1],[2],[3],[4],[5] Adverse events with eslicarbazepine acetate treatment were reported by 43.1% of people with psychiatric comorbidities (n=122/283) and 45.8% of people with intellectual disability (n=49/107). The most common adverse events were dizziness (11.4%; n=31/272), somnolence (8.8%; n=24/272) and fatigue (8.1%; n=22/272) for people with psychiatric comorbidities; and somnolence (10.1%; n=10/99), dizziness (7.1%; n=7/99) and fatigue (6.1%; n=6/99) for people with intellectual disability.[1]
Psychiatric comorbidities
Treatment with eslicarbazepine acetate in people with psychiatric comorbidities showed a responder rate of 83.1% (n=128/154) (defined by ≥50% seizure frequency reduction from baseline) at 12 months, compared with 82.5% (n=326/395) of people without psychiatric comorbidities (p=0.871). Seizure freedom was achieved by 51.3% of people with psychiatric comorbidities (n=79/154) (defined as no seizures since at least the prior visit) at 12 months with eslicarbazepine acetate treatment, compared with 51.4% (n=203/395) of people in the no psychiatric comorbidities group (p=0.984).[1]
Adverse events were reported by 43.1% of people with psychiatric comorbidities (n=122/283) compared to 30.5% of people without psychiatric comorbidities (n=261/855; p<0.001). Psychiatric adverse events were reported by 3.7% of people with psychiatric comorbidities (n=10/272) compared to 1.8% of people without psychiatric comorbidities (n=15/822; p=0.076). Discontinuation of treatment with eslicarbazepine acetate due to adverse events occurred in 17.2% of people with psychiatric comorbidities (n=45/262) compared with 11.6% of people without psychiatric comorbidities (n=94/811; p=0.019).[1]
Intellectual disability
Treatment with eslicarbazepine acetate in people with intellectual disability showed a responder rate of 60.3% (n=35/58) at 12 months, compared with 76.6% (n=222/290) of people without intellectual disability (p=0.010). Seizure freedom was achieved by 22.4% of people with intellectual disability (n=13/58) at 12 months with eslicarbazepine acetate treatment, compared with 43.1% (n=125/290) of people without intellectual disability (p=0.003).[1]
Adverse events were reported by 45.8% of people with intellectual disability (n=49/107) compared to 32.6% of people without intellectual disability (n=275/844; p=0.007). Cognitive adverse events were reported by 4.0% of people with intellectual disability (n=4/99) compared to 3.8% of people without intellectual disability (n=31/809; p=0.919). Discontinuation of treatment with eslicarbazepine acetate due to adverse events occurred in 22.4% of people with intellectual disability (n=22/98) compared with 14.8% of people without intellectual disability (n=117/789; p=0.050).[1]
Depression
Treatment with eslicarbazepine acetate in people with depression showed a responder rate of 81.0% (n=51/63) at 12 months, compared with 82.9% (n=402/485) of people without depression (p=0.703). Seizure freedom was achieved by 46.0% (n=29/63) of people with depression at 12 months with eslicarbazepine acetate treatment, compared with 52.0% (n=252/485) of people without depression (p=0.376).[1],[12]
Adverse events were reported by 42.6% of people with depression (n=60/141) compared to 32.4% of people without depression (n=322/993; p=0.017). Psychiatric adverse events were reported by 4.4% of people with depression (n=6/136) compared to 2.0% of people without depression (n=19/955; p=0.074). Discontinuation of treatment with eslicarbazepine acetate due to adverse events occurred in 18.5% of people with depression (n=24/130) compared with 12.1% of people without depression (n=114/939; p=0.044).[1]
The Euro-Esli study presents a clinical practice data set of eslicarbazepine acetate with 2,058 patients included.[13] The Euro-Esli study has a broad set of inclusion/exclusion criteria, allowing for the representation of people with conditions sometimes excluded from clinical trials.[13],[14] The Euro-Esli study includes a diverse patient population with challenging comorbidities, and provides robust evidence to support clinical practice and treatment decisions.[13],[14]
Eslicarbazepine acetate is approved in the European Union (EU) as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.[15] Eslicarbazepine acetate has also been approved in the EU as monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy in 2017.[15]
Biogen and the Douglas Grant Rehabilitation Centre, NHS Ayrshire & Arran, Scotland have announced the launch of multiple sclerosis awareness campaign, 1MSg (One Message), on World MS Day, encouraging ‘lost’ MS patients to re-engage with the support available to them.
Research conducted by the MS Trust found that one in 10 people living with MS had seen neither an MS-specialist nurse nor a neurologist in the past year1, and so will not have received the comprehensive annual review recommended by the National Institute for Health and Care Excellence (NICE)2. In addition to this, there are a number of people with MS not currently known to MS-specialists at all – those ‘lost to follow-up’. A report published by the MS Society demonstrates that there is now consensus amongst MS experts to indicate that early treatment is key in improving long-term health outcomes, slowing down irreversible damage, and reducing relapses3.
The 1MSg campaign encourages people with MS to ‘take control and know their choices’, and the Douglas Grant Rehabilitation Centre calls on patients to come back and find out what options may be available to them. Dr Jenny Preston, Consultant Occupational Therapist, Clinical Lead Neurological Rehabilitation Douglas Grant Rehabilitation Centre, NHS Ayrshire & Arran, said:
This campaign underlines the importance for people living with multiple sclerosis to get in touch with us if they haven’t had a review appointment for more than year. It is vital that we keep in touch with our patients so we are aware of how they are managing their health. We can also keep them up-to-date with new medications and treatments that could really benefit them.
The charity, Young Epilepsy, has launched a new online resource for education professionals, which provides access to information and practical tools enabling them to better support the children with epilepsy who are under their care.
A survey of 600 adults working in the education sector – including teachers, administrators, and catering assistants- was commissioned by the charity, and found that four in 10 education professionals would not be able to help a student having an epileptic seizure1.
On average epilepsy affects 112,000 children and young people across the UK2, but two-thirds of those polled have had no training about how to support the children with epilepsy in their care, including what to do in the event of a seizure1.
Other results confirmed that only 29 per cent knew that they should time the length of seizure and a third confirmed they wouldn’t know when to call for an ambulance in the event of a seizure1. Experts recommend you ring 999 if you know it’s their first seizure or if the seizure lasts for more than five minutes as prolonged seizures can result in status epilepticus, a potentially fatal condition.
The Online Guide for Schools contains essential information for anyone working with young people who have epilepsy and is available to access completely free of charge at www.youngepilepsy.org.uk/guideforschools.
Sharon White, Chief Executive of the School and Public Health Nurses Association (SAPHNA) said:“We welcome this resource which provides much needed updated guidance and, in doing so, further raises awareness of epilepsy in young people.”
Many of those polled were not aware of the different types of seizure a young person can experience. Three quarters were unaware falling to the ground and getting straight back up again could indicate that a young person is having a seizure, or experiencing strange tastes and smells (55 per cent), or staring blankly as if daydreaming (29 per cent)1.
A further survey of 356 young people with epilepsy and their parents undertaken by Young Epilepsy, found 37 per cent of young people do not have an Individual Health Care Plan at school – these plans set out key information to ensure young people are safe and included in all aspects of school life.
A number of the young people have been unnecessarily excluded from activities or opportunities at school, purely due to their condition3.
Young Epilepsy’s research also shows that many young people with epilepsy have a significant difficulty in some area of cognition or behaviour; a consequence of epilepsy that’s rarely addressed when discussing the condition, but can have a profound effect on educational development, without the right support and guidance3.
Mark Devlin, Chief Executive of Young Epilepsy said: “We know that our colleagues working in any education setting are facing many challenges every day, and most are doing a fantastic job in ensuring that every child in their care is being fully supported.
“But these latest figures show that children with epilepsy are struggling to have their conditions fully understood by the people who are playing an essential role in their educational and emotional development.
“It is our hope that this fantastic new online resource gives teachers the opportunity to learn more about epilepsy and allow the young people in their care to be fully supported to learn and be included in school life to the full.”
Elekta has announced that Elekta Unity, a transformative magnetic resonance radiation therapy (MR/RT) system that enables personalised precision radiation medicine, is in clinical use at The Christie NHS Foundation Trust. Elekta Unity combines two technologies: a state-of-the-art 1.5T MRI scanner and a best-in-class 7 MV linear accelerator, driven by breakthrough real-time adaptive radiotherapy software. It provides the ability to reshape the dose based on daily changes in shape, size and position of the tumour and surrounding healthy anatomy, as visualised with MRI, and then enables accurate dose delivery with real-time visualisation of the tumour.
“Tumours are mobile, and they can change in size, shape and location within the body as a result of treatment, disease progression or regression, and normal physiologic activity such as breathing and digestion,” said Professor Ananya Choudhury, Chair and Honorary Consultant in Clinical Oncology at the Christie NHS Trust Foundation. “Prior to Unity, we did not have the technology to assess these changes on a daily basis. Unity provides an exciting new capability to provide patients with the best and precise cancer care possible. As the most advanced approach to radiation therapy, Unity gives us the ability to adapt treatment in real time to optimise radiation delivery to the tumour while sparing nearby healthy tissue.”
“The Christie NHS Foundation Trust was a founding member of the global consortium that helped develop Unity. We are very enthusiastic about this new technology due to the ability to see what we treat in real time and the potential to improve our radiotherapy treatments,” said Professor Corinne Faivre-Finn, Honorary Consultant Clinical Oncologist and Professor of Thoracic Radiation Oncology at the Christie NHS Trust Foundation. “Not only will Unity allow more precise delivery of radiation in cancers typically treated with this important form of therapy, it will also open the door to using radiation therapy in hard-to-treat cancers. We are gratified to see our vision of next-generation radiation therapy realised and available now to the patients we serve.”
The Neurokinex Charitable Trust is now able to offer bursaries to children living with paralysis at its Neurokinex Kids centre in Gatwick thanks to receiving £20,000 in funding from The Peter Harrison Foundation Community Fund. The ‘small grants fund’ organisation supports local community and voluntary groups and this award is part of its ‘Special Needs and Care for Children and Young People’ programme.
The Neurokinex Kids Centre Sponsorship Fund will allow access to cutting-edge neurological rehabilitation for eligible children living with all forms of paralysis, including spinal cord injury, stroke, transverse myelitis and cerebral palsy.
Neurokinex is a leading, not-for-profit provider of activity-based rehabilitation. Established in 2013, it is the first and only International affiliate of the Christopher & Dana Reeve Foundation’s NeuroRecovery Network®. Neurokinex sets out to ‘redefine possibilities’ for people with paralysis: its programmes stimulate and load the entire nervous and musculoskeletal systems through carefully crafted, task-specific exercises with the assistance of skilled therapists.
The Neurokinex Kids centre for paediatric neurorecovery opened its doors in April 2018 at the Neurokinex Gatwick site. Neurokinex paediatric beneficiaries take part in activities such as active standing, cycling, swinging, climbing and walking, tailored to their neurological impairment. This offers children a multitude of benefits including improvements in neurological function, muscle bulk and quality, cardiovascular health, strength and stamina, balance and trunk control, skin and bone health, range of motion and psychological wellbeing.
“Securing this funding from The Peter Harrison Foundation will be life-changing for some of our young beneficiaries,” Kate Thornton-Jones, Fundraising Director for Neurokinex. “A spinal cord injury at any age is devastating, but it’s particularly serious in the very young. That said, children’s bodies are highly adaptable and if injured youngsters are able to access quality rehabilitation, we can work together to maximise their rehabilitation. We are very grateful to The Peter Harrison Foundation whose generosity in funding these bursaries will support more families and ensure their children can access our support.”
Please contact trustees@neurokinex.orgtrustees@neurokinex.org for information on how to apply.
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