Author: Rachael Hansford

PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease

Posted on August 3, 2018 by - Industry News, Neurology News

  • European Medicines Agency PRIME (PRIority MEdicines) status is granted to medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options
  • RG6042 has the potential to be the first therapy targeting the underlying cause of Huntington’s disease, a fatal neurodegenerative rare disease
  • Third PRIME designation for a Roche medicine

Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD). RG6042 has demonstrated its ability to reduce the toxic mutant huntingtin protein (mHTT), which is believed to be the underlying cause of HD, in a Phase I/IIa study.1 PRIME is a designation implemented by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency, and thus potentially enable them to reach patients earlier.2

“We are very pleased that the European Medicines Agency has granted PRIME designation for RG6042, as there is an urgent medical need to find treatment options for families affected by Huntington’s disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Preliminary data on RG6042 were the first to show that levels of toxic mutant huntingtin protein can be lowered in adults with Huntington’s disease, and we are working closely with the EMA and other health authorities to initiate a global phase III study as soon as possible.”

PRIME designation for RG6042 is primarily based on the data from an exploratory Phase I/IIa trial of RG6042 that demonstrated a significant reduction in mHTT, which breaks down the nerve cells in the brain.1 The study demonstrated a mean 40% (up to 60%) reduction of the specific HD protein in the cerebrospinal fluid (CSF) of adult patients treated with RG6042 for three months at the two highest doses. Furthermore, levels of mHTT measured in the CSF were still declining in the majority of treated patients (~70%) as of the last measurement in the study.3  RG6042 was well tolerated in this short initial study.1 These data were shared at the CHDI 13th Annual HD Therapeutics Conference in March 2018,3 and updated results were presented at the American Academy of Neurology (AAN) Annual Meeting in April 2018.4

Roche will initiate a pivotal phase III study to evaluate RG6042 in a larger patient population to further characterise the safety profile and determine if it can slow the progression of HD in adults.

About RG6042

RG6042 is a second-generation modified antisense oligonucleotide (ASO) designed to reduce the production and levels of mHTT protein by targeting human HTT mRNA.5 RG6042 is the result of a comprehensive drug discovery programme between Roche and Ionis Pharmaceuticals focused on optimising the potency, specificity and tolerability of an ASO targeting human HTT mRNA. RG6042 is the most advanced compound in clinical development to target toxic mutant huntingtin protein (mHTT), which is believed to be the underlying cause of HD. Treatment with RG6042 has the potential to slow or stop disease progression in all people with HD.1

About Huntington’s disease

Huntington’s disease is a rare genetic, progressive condition that causes the nerve cells in the brain to break down, which severely affects a person’s everyday functions such as mobility and thinking.6 It has a devastating impact on people living with the disease, and the hereditary nature of HD means it profoundly affects entire families.6 As the disease progresses, people with HD may develop personality changes, difficulty walking and swallowing, as well as having a significant cognitive impact.6 Survival ranges from approximately 10-20 years following motor onset of the disease.6

There is no known cure for HD and no approved therapies that treat the underlying cause. The estimates for the number of people affected by Huntington’s vary between geographic regions. Huntington’s disease is the most common monogenic neurological disorder in the developed world, with an estimated prevalence of 12.3/100,000 in the United Kingdom, equating to ~8,000 people.7

About Roche in neuroscience

Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Huntington’s disease and autism spectrum disorder.

About Roche Products Limited

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology and infectious diseases. Roche is also the world leader in in–vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life, safety and survival of patients. Twenty-eight medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. Roche employs over 2,000 people in pharmaceuticals and diagnostics in the UK.

For more information: http://www.roche.co.uk

All trademarks used or mentioned in this release are protected by law.

Adverse event reporting

Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44(0)1707 367554.

References

  1. Ionis Pharmaceuticals. 2018. Press release: IONIS-HTT Rx (RG6042) top-line data demonstrate significant reductions of disease-causing mutant Huntingtin protein in people with Huntington’s disease. [Internet; cited 2018 July]. Available from: http://ir.ionispharma.com/node/23401/pdf.
  2. European Medicines Agency. PRIME Designation. [Internet; cited 2018 July]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000660.jsp&mid=WC0b01ac05809f8439.
  3. CHDI 13th Annual HD Therapeutics Conference 2018. Press Release: Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease. [Internet; cited 2018 July]. Available from: https://chdifoundation.org/ionis-pharmaceuticals-licenses-ionis-htt-rx-to-partner-following-successful-phase-12a-study-in-patients-with-huntingtons-disease/. (Data on file).
  4. Ionis Pharmaceuticals. 2018. Press release: New Data from IONIS-HTT Rx Phase 1/2 Study Demonstrates Correlation Between Reduction of Disease-causing Protein and Improvement in Clinical Measures of Huntington’s Disease. [Internet; cited 2018 July]. Available from: http://ir.ionispharma.com/node/23661/pdf.
  5. Leavitt B, Tabrizi S, Kordasiewicz H et al. Discovery and early clinical development of ISIS-HTTRx, the first HTT-lowering drug to be tested in patients with Huntington’s disease (PL01.002). Neurology 2016;86(Suppl. 16):PL01.002. [Internet; cited 2018 July]. Available from: http://n.neurology.org/content/86/16_Supplement/PL01.002.
  6. NHS Choices. Huntington’s disease: Overview. [Internet; cited 2018 July]. Available from: https://www.nhs.uk/conditions/huntingtons-disease/.
  7. Wexler N, et al. Incidence of adult Huntington’s disease in the UK: a UK-based primary care study and a systematic review. BMJ Open 2016; 6(2).

UK’s Oldest Surgical College Gears Up for First-Ever Cycling Symposium Across Britain

Posted on August 2, 2018 by - Industry News, Neurology News

The UK’s oldest surgical Royal College is switching gears and taking to the road, on the first-ever ‘Cycling Symposium’ across the UK.

Pictured: Giles Bond-Smith, Katherine Hurst and Mike Silva

On behalf of the 500+ year-old Royal College of Surgeons of Edinburgh (http://www.rcsed.ac.UK), a dozen surgeons and surgeons-in-training will be setting off on 1 September on a gruelling seven-day bicycle trek from Southampton to Edinburgh – in a bid to spread the word on the latest news and advances in the field of surgery.

On this mission, the team of experienced consultants and talented trainees will stop each evening to conduct a series of masterclasses on key surgical topics. These include highlighting the importance of patients’ cardiovascular fitness prior to surgery, an update on the College’s groundbreaking anti-bullying campaign #LetsRemoveIt, as well as other subjects surrounding safety in the operating theatre, reducing the risk of infections, ‘never events’ and topics of special interest in vascular surgery and trauma surgery.

The team, led by Oxford-based Consultant Liver, Pancreatic and General Surgeon and RCSEd Deputy Surgical Director of the Regional Advisory Network, Mr Mike Silva and Academic Surgical Fellow at Oxford University Hospital and Member of the RCSEd’s Trainees’ Committee Miss Katherine Hurst, will set off from Southampton, pedalling through Oxford, Birmingham, Sheffield, Middleborough, Newcastle and Carlisle to arrive in Edinburgh after a journey of almost 550 miles. Keen cyclists are invited to take part too, by joining the surgeons and cycling part of the route with them.

Spearheading the cycling effort Mr Mike Silva said:

“Poor physical fitness can lead to costly yet avoidable complications after surgery and there is strong evidence that improving a patient’s functional capacity lends to better surgical outcomes. In October 2014, the RCSEd launched a UK-wide education campaign to get patients exercising adequately prior to their surgery.  A key aspect of the ‘Cycling Symposium’ will therefore highlight the positive aspects of physical activity like cycling.

“#LetsCycleIt will also incorporate a series of surgical masterclasses each evening. The topical discussions will be delivered by surgeons who have taken part in the ride to a diverse audience that will include members of the public, medical students, junior doctors in training and practicing surgeons.”

Cycling alongside Mr Silva will be Miss Katherine Hurst, an Academic Surgical Fellow at Oxford University Hospital:

“Over 80% of the College’s UK members are based in England and Wales, so we’re taking to the roads to highlight the presence of RCSEd throughout Britain, and the work undertaken to improve patient outcomes and ensure surgery is a profession that remains thriving and inclusive. The College has been championing programmes such as the hugely successful national anti-bullying campaign #LetsRemoveIt, and showcasing roles for women in surgery. Studies estimated that bullying within the NHS costs UK organisations nearly £14billion per year, and healthcare professionals have attributed disruptive behaviour alone to 67% of adverse patient events, 71% of medical errors, and 27% of perioperative deaths. Bullying and harassment in the workplace is no longer acceptable and our travelling symposium will inform and equip surgeons to tackle this detrimental behaviour.

“Women form an ever increasing proportion of the UK’s surgical workforce and the College has an increasing number of female trainees, surgeons and Council members.  A number of female surgeons will be participating as riders and will showcase opportunities for women choosing a career in surgery.”

The #LetsCycleIt route will be open to local cyclists, both healthcare professionals and the public. To join in any of the seven daily stages, register online beforehand via the RCSEd website.

The President of the Royal College of Surgeons of Edinburgh Professor Mike Lavelle-Jones said:  “I wish Mike and Katie, along with all the other cyclists, a most successful trip and I look forward to meeting up with them from time to time along the way. This is a unique event, which provides an opportunity to emphasise the importance of fitness, not only to our patients but also to the population at large. The cycle ride across the heart of England is a bold initiative and I applaud all of the team for their sterling efforts.”

Cycling Surgical Symposium Agenda:

Oxford – Saturday 1 September 2018

Birmingham – Sunday 2 September 2018

Sheffield – Monday 3 September 2018

Middlesbrough – 4 September 2018

Newcastle – 5 September 2018

Carlisle – Thursday 6 September 2018

  • Update on #LetsRemoveIt campaign – Miss Katherine Hurst
  • Stop that bleeding; gems from a practicing vascular surgeon – Mr Barnabas Green
  • Improving surgical outcomes; the cost of surgical site infections and the success of preventative measures – Mr Giles Bond Smith
  • Hot Gallbladders; when should you back off and live to fight another day? – Mr Paul Gallagher
  • The cyclists derriere and other painful posteriors – Mr Stephen Boyce
  • When do I need a liver surgeon? Tips on how to manage liver trauma – Mr Michael Silva
  • Am I fit enough for my surgery, doctor?  How to climb that mountain just to get to your operation – Mr Christopher Darby
  • Is ‘never event’ a misnomer? Reflections of a NHS manager on improving the working environment for safe surgical care – Mr Rainer Buhler

Young Epilepsy and Veriton Pharma Ltd announce key partnership agreement in support of the charity’s ‘Rules 4 Schools’ campaign

Posted on July 31, 2018 by - Industry News, Neurology News

Young Epilepsy and Veriton Pharma Ltd (Veriton) have announced a key agreement, where the organisations will work in partnership to deliver the ‘Rules 4 Schools” element of the charity’s newly launched ‘#InTheMoment’ initiative.

Through this policy influencing initiative, Young Epilepsy is looking to break down the obstacles to opportunity for the 55,800 school aged children (5-18 years) with epilepsy in the UK1.  Starting with the ‘Rules 4 Schools’ campaign, the key aim for the charity, supported by Veriton, is to challenge current thinking and encourage systemic change in priority areas.

Since 2014, all state schools in England are legally required to have a policy on supporting children with medical conditions such as epilepsy.  This means that all children with epilepsy should have an Individual Healthcare Plan (IHP) which sets out essential information such as how the condition affects them and what to do in an emergency. However, Young Epilepsy believe many schools have some way to go in adequately supporting children with epilepsy.

Schools need to make sure that children with epilepsy have the support they need to fulfil their potential in an inclusive and safe environment.  In a survey2 we carried out in 2017, we found that 1 in 3 (36%) of young people with epilepsy still don’t have an IHP at school and only 51% of families surveyed said that school staff had been trained to support a young person with epilepsy.  This needs to be dramatically improved and we think the ‘Rules 4 Schools’ can help to achieve this.”

Matt Robertson, Young Epilepsy

The ‘Rules 4 Schools’ campaign will concentrate on four key areas:

  1. Encouraging or working with schools to ensure all young people with epilepsy have an individual healthcare plan
  2. Encouraging or working with schools to have a policy on supporting pupils with medical conditions
  3. Achieving a requirement on schools to publish medical conditions policies on their websites
  4. Campaigning for school inspections to include a routine check for support for pupils with medical conditions

We are delighted to be working in partnership with Veriton on this critically important campaign and we really look forward to making a difference to as many young people with epilepsy as possible through the #InTheMoment – Rules 4 Schools initiative.”

Matt Robertson

For more information about Young Epilepsy and the campaign, please visit http://www.youngepilepsy.org.uk/rules4schools and http://www.youngepilepsy.org.uk and https://inthemoment.org.uk

References:

  1. Joint Epilepsy Council (2011) Epilepsy prevalence, incidence and other statistics 
    http://www.epilepsyscotland.org.uk/pdf/Joint_Epilepsy_Council_Prevalence_and_Incidence_September_11_(3).pdf
  2. Young Epilepsy (2017) Epilepsy support in schools: Survey of young people with epilepsy and their parents and carers 
    https://youngepilepsy.org.uk/images/Epilepsy_support_in_schools_report_-_Oct_17.pdf

Further information:

Young Epilepsy is a member of the Health Conditions in Schools Alliance which is made up of over 30 organisations including charities, healthcare professionals and trade unions working collaboratively to make sure children with health conditions get the support they need at school.

Young Epilepsy is the only national charity with the sole purpose of supporting children and young people aged under 25 with epilepsy and associated conditions, as well as their families. The charity has been improving the lives of children and young people living with epilepsy and related neurological conditions for over 120 years with the aim of enabling them to fulfil their potential and ensure they have the best quality of life. Currently in the UK, there are around 112,000 young people with epilepsy of which 55,800 are school aged children (5-18 years)1.

About Veriton Pharma Ltd

Founded in 1997 by Dr Graham March MrPharmS, the company has pioneered the development and availability of innovative products and specialised medicines in the fields of epilepsy, neurology and rare paediatric conditions.  For more information visit http://www.veritonpharma.com

Advantages and disadvantages of taking Z drugs to treat sleep disturbance in people with dementia

Posted on July 25, 2018 by - Industry News

Research presented at The Alzheimer’s Association International Conference (AAIC) recently shows that “Z-drugs” such as zolpidem, zopiclone and zaleplon, often prescribed to treat insomnia, could lead to an increase in falls for people with dementia.

Researchers from the Norwich Medical School University of East Anglia found that the use of Z-drugs is associated with a 40% increase in any type of fractures, with this risk increasing with higher doses of the medication.

Sleep disturbances are a common symptom of dementia, and can make life for the person with dementia, and their carer, really challenging. To tackle this, we’re funding research to better understand the importance of sleep in brain health.
However, the finding in this study that people who had taken Z-drugs to sleep were more prone to falls and injuries as a result echoes current research. We recommend personalised non-drug solutions, like avoiding caffeine or taking exercise in the day, to help with sleep.With dementia prevalence rising – the number is set to be 1 million by 2021 – only research will beat this devastating condition for good.

Dr Doug Brown, Chief Policy and Research Officer at Alzheimer’s Society

Read ACNR’s article, “Falls as a result of being on Z-drugs for insomnia” in the May-July 2018 issue.

Akcea and Ionis Announce European Commission Approval of Tegsedi™ ▼ (inotersen)

Posted on July 23, 2018 by - Industry News

Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc., have announced  that TegsediTM (inotersen) has received marketing authorisation approval from the European Commission (EC) for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). This follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).1

“With the EC’s decision, inotersen is now the world’s first and only RNA-targeted therapeutic approved for patients with hATTR amyloidosis. With subcutaneous delivery, inotersen puts treatment in the patients’ hands while bringing the significant benefits shown in the NEURO-TTR study in both measures of neuropathy and quality of life for people living with this serious and fatal disease. This is an important day for the hATTR amyloidosis community as we believe inotersen enables people and their families impacted by this disease to move forward with their lives,” said Paula Soteropoulos, chief executive officer at Akcea Therapeutics. “Today is a milestone for Akcea with our first drug approval. It is an achievement we share with the courageous hATTR patient community in Europe and around the globe. We are ready to launch inotersen along with our patient and physician support services across Europe.”

The abnormal formation and aggregation of transthyretin (TTR) protein results in TTR amyloid deposits throughout the body and is the underlying cause of hATTR amyloidosis. Inotersen is designed to block production of the TTR protein. In the NEURO-TTR study, treatment with inotersen produced substantial reductions in the levels of the TTR protein regardless of mutation type or stage of disease.2

“hATTR amyloidosis is an inherited, progressive and fatal disease for which treatment options are limited. The approval of inotersen brings us into a new era of treatment with an efficacious and disease modifying medicine that potentially allows patients to achieve a greater degree of independence,” said Teresa Coelho, M.D., neurologist and neurophysiologist at Santo António Hospital, Porto, Portugal. “Inotersen has demonstrated rapid and sustained benefits in improving the course of this disease and preserving quality of life.”

The European Commission’s approval of inotersen was based on results from the Phase 3 NEURO-TTR study in patients with hATTR amyloidosis, with symptoms of polyneuropathy.2 Results from that study demonstrated that patients treated with inotersen experienced significant benefit, compared to patients treated with placebo across both co-primary endpoints: the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QoL-DN) and modified Neuropathy Impairment Score +7 (mNIS+7), a measure of neuropathic disease progression.2
Inotersen is associated with risk of thrombocytopenia and glomerulonephritis. Enhanced monitoring is required to support early detection and management of these identified safety risks.2

“Today, we are thrilled to see our successful research and development efforts result in the approval of an important new medicine for patients with hATTR amyloidosis. Using our antisense technology platform, we set out to design a therapy to block the production of the underlying cause of this disease, the TTR protein,” said Brett P. Monia, Ph.D., chief operating officer at Ionis Pharmaceuticals. “Approval of inotersen further establishes Ionis as a multi-product company. We are confident that the experienced team at Akcea will deliver on the promise of inotersen. We are grateful to all of the physicians and patients who participated in the inotersen clinical program and who made this landmark approval possible.”

For important safety information for inotersen, including method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics (SmPC), available from the EMA website at www.ema.europa.eu.

Inotersen is also under regulatory review in the United States and Canada. Inotersen’s U.S. Prescription Drug User Fee Act, or PDUFA, date is October 6, 2018.

ABOUT INOTERSEN

Inotersen is an antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) production. Inotersen is approved in the E.U. for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR) and is currently under regulatory review in the U.S. and Canada.
The approval is based on data from the NEURO-TTR study which was a Phase 3 randomised (2:1), double-blind, placebo-controlled, international study in 172 patients with hATTR amyloidosis with symptoms of polyneuropathy. The 15-month study measured the effects of inotersen on neurological function and on quality-of-life by measuring the change from baseline in the modified Neuropathy Impairment Score +7 (mNIS+7) and in the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) total score. Inoterson provided significant benefit on both of these co-primary endpoints in the NEURO-TTR study, including improvement in disease relative to baseline measurements in both co-primary endpoints for a substantial portion of patients.
Inotersen is associated with risk of thrombocytopenia and glomerulonephritis. Enhanced monitoring is required to support early detection and management of these identified risks. The most frequently observed adverse reactions during treatment with inotersen were events associated with injection site reactions. The other most commonly reported adverse reactions (over 10%) seen with inotersen were nausea, anaemia, headache, pyrexia, peripheral oedema, chills, vomiting, thrombocytopenia and platelet count decreased.

The approval is also based on data from the NEURO-TTR Open Label Extension (OLE) which is an ongoing study for patients who completed the NEURO-TTR study, designed to evaluate the long-term efficacy and safety of inotersen. For more information on inotersen, please visit www.TEGSEDI.eu.

ABOUT HEREDITARY TRANSTHYRETIN (hATTR) AMYLOIDOSIS

hATTR amyloidosis is a progressive, systemic and fatal inherited disease caused by the abnormal formation of the TTR protein and aggregation of TTR amyloid deposits in various tissues and organs throughout the body, including in peripheral nerves, heart, intestinal tract, eyes, kidneys, central nervous system, thyroid and bone marrow.3,4 The progressive accumulation of TTR amyloid deposits in these tissues and organs leads to sensory, motor and autonomic dysfunction often having debilitating effects on multiple aspects of a patient’s life.4 Patients with hATTR amyloidosis often present with a mixed phenotype and experience overlapping symptoms of polyneuropathy and cardiomyopathy.4

Ultimately, hATTR amyloidosis results in death within three to fifteen years of symptom onset. Therapeutic options for the treatment of patients with hATTR amyloidosis are limited and there are currently no disease-modifying drugs approved for the disease. There are an estimated 50,000 patients with hATTR amyloidosis worldwide.4

References

1 European Medicines Agency. Tegsedi. Available here.  Last accessed July 2018.
2 Benson, MD et al. (2018) Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. NEJM. 379:22-31.
3 Damy T, et al. (2015) Cardiac Findings and Events Observed in an Open-Label Clinical Trial of Tafamidis in Patients with non-Val30Met and non-Val122Ile Hereditary Transthyretin Amyloidosis. J Cardiovasc Transl Res. 8(2):117-127.
4 Hawkins PN, et al. (2015) Evolving landscape in the management of transthyretin amyloidosis. Ann Med. 47(8):625-638.

Celebrating 16 years of the Parkinson’s MasterClass

Posted on July 23, 2018 by - Industry News

This year, the Neurology Academy celebrate 16 years since it first launched the Parkinson’s MasterClass.

Beginning as a conversation amongst clinical colleagues, the four founders Dr Peter Fletcher, Doug MacMahon, Sue Thomas and David Stewart, were concerned about a lack of knowledge about Parkinson’s.

Intending to run just two programmes of training and mentoring ‘for clinicians, by clinicians’, the MasterClass has now supported over 1,500 healthcare professionals to develop Parkinson’s specialisms, and is routinely booked up over a year in advance. The Foundation level course has doubled its capacity, increasing to give much needed spaces to the junior registrars who now need to include Parkinson’s training in their rotation.

‘It feels like there’s a dearth of doctors specialising as geriatricians at the moment – we want to inspire the registrars we see, and encourage them in pursuing Parkinson’s care,’ says Sarah Gillett, our Managing Director.

With the rise in an aging population, geriatrics is a growing demand, and Parkinson’s patients regularly fall in the ‘older people’ bracket; the British Geriatrics Society note that the condition is one of the most common neurological conditions to affect older people. Members of our faculty are often saying how rewarding they find caring for people with Parkinson’s, and many began teaching to encourage other young doctors to think about going into geriatrics.

The Parkinson’s Masterclass is now one element of the Neurology Academy, which supports a broad range of professionals across a wider array of topics – all with an ongoing drive to enable existing clinical specialists to share their knowledge and enthusiasm with their peers, encouraging confidence and improved practice across the UK.

To celebrate the past 16 years, the Neurology Academy is featuring a Star Showcase, sharing the stories of some of its once-students, now faculty members to inspire and encourage other professionals in their own journeys.

For more information, please contact Sarah Gillett, Managing Director  Neurology Academy, at sarahgillett@neurologyacademy.org or call her on (T) 01143 27 02 30 or (M) 07771 54 56 20

The full story is running on the Neurology Academy website and uses the Twitter hashtag #PdMC16

MS Masterclass 2018 winners announced

Posted on July 23, 2018 by - Awards & Appointments

All MS MasterClass attendees carry out a workplace project as a key part of the course. This will be on an issue they choose in the area that they work, from service development to epidemiology, audit to patient management. Projects are presented to their course peers and the teaching faculty, who jointly choose a winner and a runner up for the year.

MasterClass 3 project award winner

Rachel Dorsey-Campbell, Impact of a pharmacy-led prescribing service on the monitoring of natalizumab patients

Runner up: Dr Jessica Vaz, JCV in Jersey

MasterClass 2 project award winner

Dr Francisco Javier Carod Artal, Epidemiology of MS in the Highlands: Prevalence, incidence and time to get a proper diagnosis and start DMT

Runner up: Dr Rachelle Shafei, Listeriosis prevention in alemtuzumab treated patients

See https://multiplesclerosisacademy.org/resources/delegate-projects/snapshots/ for a link to all projects.

World Brain Day: Clean Air for Brain Health

Posted on July 20, 2018 by - Neurology News

22 July: World Brain Day 2018 – Clean Air for Brain Health

Global air pollution is not a problem that only affects lung health. Recent data show that airborne pollutants account for 30 percent of acute stroke cases worldwide. Cleaning up the air we breathe would help to prevent various serious and common neurological disorders, as the World Federation of Neurology aims to emphasise on World Brain Day 2018, which is devoted to highlighting the negative impact of air pollution on brain health.

Every year on 22 July, the World Federation of Neurology (WFN) stages World Brain Day. Around 120 organisations around the world participate in this awareness-raising initiative. The focus in 2018 is a topic that is growing in importance as a result of a number of recent scientific studies: the negative effects of high air pollution levels on the brain. “Clean Air for Brain Health” is this year’s theme.

The impact on health of environmental pollution, and air pollution in particular, is increasing all the time. Recent estimates put the annual number of deaths attributable to polluted air at 9 million worldwide.

“The Global Burden of Disease study, carried out by an international team using data from 188 countries, found that up to 30 percent of the global stroke burden can be traced back to pollutants in the air,” explained World Brain Day Chair Prof Mohammad Wasay from Karachi. “This was the reason behind our decision to select an aspect of environmental pollution as the theme for World Brain Day 2018.”

A complex global problem


The connection between harmful gases and particles in the air and brain health is a worldwide problem, and also a complex one. According to Prof Jacques Reis, head of the World Federation of Neurology’s Environmental Neurology Applied Research Group:

Air pollution refers to diffuse, often invisible contamination by damaging bioaerosols containing pollen, spores, particles and toxic substances. The pollutants can stem from natural sources or may be due to human activity.”

Additionally, the phenomenon can vary sharply – both quantitatively and qualitatively – depending on the situations in which people live and work. It includes:

  • Indoor air pollution, e.g. from heating systems, cooking on open wood fires, kerosene and tobacco
  • Outdoor pollution, e.g. industrial and vehicle exhaust fumes, waste incineration and dust
  • A distinction is made between primary and secondary air pollutants: the former are gases and particles that themselves have harmful effects, while the latter are the result of chemical reactions between natural and/or man-made substances (such as ozone)

“The problem is different in major cities compared with rural areas. Some air pollutants have a local or regional impact, but the effects of others can be international,” says Prof Reis.

In May this year, the World Health Organisation (WHO) found that nine-tenths of the world’s population breathe polluted air. And three billion people use harmful fuels in their homes for cooking and/or heating.

Understanding of toxic effects constantly improving

In recent years, scientists have uncovered significant evidence of the way in which air pollution affects the brain, and how this is damaging neurological health all over the world. As Prof Reis explains: “Pollutants enter the body through the respiratory and alimentary tracts. They cause subthreshold inflammatory responses, and reach the brain either via the blood stream or the upper respiratory tract. The resulting damage to intestinal microbiota can also have an impact on the brain.”

The list of potential effects is long: atherosclerosis, oxidative stress, inflammatory responses throughout the body, blood vessel damage, increased blood pressure, impairment of the blood-brain barrier’s protective mechanisms, and heart problems could be connected to air pollution. Possible damage to brain cells such as microglia cells and astrocytes has also been identified. At the cellular level, air pollutants interfere with mitochondria – often referred to as cells’ “powerhouses” – and genetic material like DNA. Pollutants bring about epigenetic changes and shorten telomeres, the protective caps on the ends of chromosomes. The latter is seen as a sign of cell ageing.

Little wonder, then, that air pollution is suspected of playing a part in a growing number of syndromes and neurological diseases. Initial findings suggest it could play a role in autism, attention deficit disorders in children, dementia and the development of Parkinson’s disease, although reliable data are not yet available.

Caused by humans – but modifiable

Decisive changes in behaviour could significantly reduce the risks posed by environmental factors that cause brain health to deteriorate. “Preventing neurological disorders is not just a concern for individuals; action needs to be taken at the societal level as well. This is particularly true of man-made environmental impacts, which mankind in turn can ultimately influence. These are important risk factors for diseases affecting the blood vessels in the brain, as well as neurodegenerative conditions,” said Prof Wolfgang Grisold, the WFN’s Secretary General.

“This worldwide public health problem requires effective environmental and health-policy strategies aimed at reducing air pollution. It is not just a matter of lung health, but the health of the very organ that makes us humans: our brains,” Prof Grisold emphasised.

Wake-up call for the international community

Speaking about this year’s World Brain Day, WFN President Prof William Carroll believed that there is only one possible interpretation of the available scientific data on the effects of air pollution on brain health: “Each and every one of us, every country in the world and the international community must see this as a wake-up call. Policymakers need to do more to tackle neurological disorders and diseases. This means making brain health one of the highest-level healthcare priorities and providing additional funds to address the issue.”

The annual World Brain Day takes place on 22 July and is devoted to a different topic each year. The choice of date was no coincidence: the WFN was founded on 22 July 1957.

INSIGHTEC’s Focused Ultrasound Earns Positive NICE Guidance for Treatment of Essential Tremor

Posted on July 2, 2018 by - Industry News

Unilateral MRI-guided Focused Ultrasound Thalamotomy for Treatment-resistant Essential Tremor Recognised by National Institute for Health and Care Excellence

INSIGHTEC®, a global medical technology innovator of incisionless surgery, has announced that The National Institute for Health and Care Excellence (NICE) issued a positive NICE guidance for unilateral MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor (ET). ET affects more than one million people in the UK and impacts their ability to perform everyday tasks due to uncontrollable shaking of their hands.

The Imperial College Healthcare NHS Trust is the first and only site in the UK with the Exablate Neuro™ technology to treat essential tremor. To date 16 patients with ET have been treated at St. Mary’s by an expert, multidisciplinary team including Professor Wladyslaw Gedroyc, Consultant Radiologist, Dr. Peter Bain, Consultant Neurologist and Professor Dipankar Nandi, Consultant Neurosurgeon.

Essential tremor patients treated at St Mary’s have experienced very substantial improvement in the severity of their tremor as well as their quality of life. In addition, the safety profile is favourable with minor, often temporary side effects experienced by this group.

Professor Dipankar Nandi, Consultant Neurosurgeon and Head of Department, St Mary’s Hospital, Imperial College Healthcare NHS Trust. 

During the treatment, ultrasound waves pass safely through the skull to ablate a tiny spot in the brain considered to be responsible for the tremor. The result is often an immediate improvement of the tremor in the treated hand. Due to the incisionless nature of focused ultrasound, there is no risk of infection and patients recover quickly.

The positive NICE guidance adds to the growing body of positive health technology determinations for incisionless brain surgery using INSIGHTEC’s Exablate Neuro. This is a critical step toward increased patient access to our technology around the globe.

Maurice R. Ferré, MD, Chief Executive Officer and Chairman of the Board of INSIGHTEC

For more information on the NICE guidance, please visit NICE.org.uk.

About INSIGHTEC

INSIGHTEC is a global medical technology innovator transforming patient lives through incisionless brain surgery using MR-guided focused ultrasound. The company’s award-winning Exablate Neuro™ is used by neurosurgeons to perform the Neuravive™ treatment to deliver immediate and durable tremor relief for essential tremor patients.  Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, Florida, with offices in Dallas, Tokyo and Shanghai.

For more information, please visit: http://www.insightec.com/