23 January 2017
REX initiates RAPPER III: Clinical Trial in Multiple Sclerosis
- Ethics Committee Approval from NHS’s National Institute for Health Research (NIHR)
- Partnership with East Kent Hospitals University NHS Foundation Trust, and Kent University
23 January 2017: Rex Bionics Plc (AIM: RXB), the pioneer of the REX Robot technology that enhances the mobility of wheelchair users, Rex Bionics Plc (AIM: RXB), the pioneer of the REX Robot technology that enhances the mobility of wheelchair users, is pleased to announce that the ethics committee of the UK NHS’s National Institute for Health Research has approved the start of a clinical trial to evaluate the use of the REX robotic mobility device in patients with multiple sclerosis (MS). The trial will be conducted at the Canterbury site of the East Kent Hospitals University NHS Foundation Trust under the direction of Dr Mohammed Sakel, Consultant and Director of the Neurorehabilitation service.
The intent is to evaluate the feasibility and safety of using the REX Robot in rehabilitation for people with MS who have moderate to severe mobility restriction. The trial, known as RAPPER III, will recruit ten people with a primary diagnosis of MS and an Expanded Disability Status Scale (EDSS) score of between 6 (defined as “requires a walking aid to walk about 100m”) and 7.5 (defined as “Unable to take more than a few steps. Restricted to wheelchair and may need aid in transferring”).
The primary end-point of the trial is the completion of a transfer, stand, balance and walk rehabilitation programme over six weeks. The aim of the programme is to increase strength, improve balance-related skills and walking ability. There are a number of secondary end-points, including the Multiple Sclerosis Walking scale (MSWS-12) and the Multiple Sclerosis Impact scale (MSIS-29).
The first patient is expected to be recruited shortly, with preliminary data presented later in 2017.
"We are optimistic about the REX’s potential for benefitting patients with multiple sclerosis. I am delighted to see the enthusiasm of our MS patients and the Charity Kent MS Therapy Centre"
Dr Mohammed Sakelthe Principal Investigator of the trial
"Our RAPPER II trial established the safety and feasibility of the REX in a single treatment. We are delighted that the specialists in Canterbury are now interested in exploring the use of REX in MS, and in a course of treatment over several weeks."
Crispin SimonChief Executive of Rex Bionics plc
A copy of this announcement has been posted on the Company's website at www.rexbionics.com/
For further information please contact:
Rex Bionics Plc
Crispin Simon, Chief Executive Officer
+44 (0) 781 086 6386
Peter Worrall, Chief Financial Officer
+44 (0)1428 645416
Stifel Nicolaus Europe Limited (NOMAD and Broker)
Jonathan Senior/ Stewart Wallace / Ben Maddison
+44 (0) 20 7710 7600
Consilium Strategic Communications
Mary-Jane Elliott / Chris Welsh / Jessica Hodgson / Lindsey Neville
+44 (0) 203 709 5700
MS is a chronic inflammatory - demyelinating disease of the central nervous system (CNS) leading to progressive impairment of function. MS is diagnosed in 3.5 to 6.6 people per 100,000 of the population each year, equivalent to about 1,800 to 3,400 people year in England and Wales. Prevalence is equivalent to about 52,000 to 62,000 people. Some people with MS develop few symptoms, but for others the disease and society’s interactions with them lead to problems affecting all aspects of their lives. NICE Guidelines recommend all patients with MS should have access to specialist Neurorehabilitation services.
Balance is often compromised by the inflammatory process which can also impact on motor and sensory nerve pathways causing reduced muscle power, co-ordination, walking and functional abilities. It is estimated that 15 years after disease onset, 15% of MS patients need technical aids for walking and 29% use a wheelchair. The reduction in mobility stems from various factors including weakness of muscles, spasticity, impaired balance, falls and fear of falls.
The Multiple Sclerosis Foundation estimates that more than 400,000 people in the United States and about 2.5 million people around the world have MS. Between 2008 and 2012, the cost of drugs for the treatment of MS in the US doubled from $4 billion to nearly $9 billion annually. The annual cost for the gold standard interferon therapy is around $60,000.
About the RAPPER Trial Programme
Rex Bionics' mission is to establish Robot-Assisted Physiotherapy as a fully-reimbursed standard of care for clinic and home use for a range of neurological conditions. RAPPER III is part of a programme of trials delivering the evidence to support the mission.
RAPPER I (Robot-Assisted Physiotherapy Exercises with REX) was a small feasibility study conducted in the UK.
RAPPER II is a trial to evaluate the feasibility and safety of a set of customised exercises performed in a REX in a single session by users with spinal cord injury. Data from the second interim analysis were presented on 3rd November 2016 at the American College of Rehabilitation Medicine (ACRM) and showed that 52 out of 56 volunteers (93%) were able to complete the transfer-walk-exercise protocol - the primary endpoint of the trial. Sleep, Spasticity and Pain metrics were positive and there were no Serious Adverse Events.
RAPPER III is a trial to evaluate the feasibility and safety of using the REX Robot in rehabilitation for people with MS who have moderate to severe mobility restriction. The trial will recruit ten patients. The primary end-point is the completion of a transfer, stand, balance and walk rehabilitation programme over six weeks. The aim of the programme is to increase strength, improve balance-related skills and walking ability. There are a number of secondary end-points, including the Multiple Sclerosis Walking scale (MSWS-12) and the Multiple Sclerosis Impact scale (MSIS-29).
About Rex Bionics Plc
Rex Bionics is the pioneer of the "REX" that provides robotic standing, walking and exercise support for wheelchair users; and was founded by two British engineers with first-hand experience of the needs of wheelchair users. REX is used by people who have suffered a spinal cord injury, stroke or other traumatic brain injury; and people with multiple sclerosis, muscular dystrophy and cerebral palsy.
We are working with physiotherapists to develop the concept and practice of Robot-Assisted Physiotherapy (RAP); and also offer REX P, for use in the home, enabling customers to walk and stand with their hands free - providing more work and recreation options.
Wheelchair users are at risk of developing numerous medical complications from extended periods of sitting. By enabling them to spend more time standing, walking and exercising, REX may offer significant health benefits, including improved sleep and maintenance of joint range, and a reduction in spasm, pain, common abdominal problems and prescription drug use.
Our commitment to engineering excellence is complemented by a commitment to clinical science and the RAPPER II clinical trial results show high levels of practicality, safety and user enthusiasm.
Our Vision is that every day, around the world, thousands of people get relief with REX, from the harm - the pain, discomfort and inconvenience - of neurological accidents and illnesses; and that many will be cured.