LONDON, June 11, 2018 /PRNewswire/ --
Recruitment Begins in 7
European Countries
BTG plc (LSE: BTG), the global healthcare company, today
announces the start of ELEVATE: A randomizEd
ControlLed Study of PnEumRx™ Endobronchial Coil
System (Coils) Versus Standard of Care Medical
MAnagement in the Treatment of Subjects with Severe
Emphysema.
(Logo:
http://photos.prnewswire.com/prnh/20150805/255981LOGO )
The goal of ELEVATE is to confirm findings of previous
randomized controlled trials with the PneumRx™ Endobronchial Coil
System in treating patients with severe emphysema.
The RENEW study presented in May
2016, showed that Coils can safely and effectively treat
severe emphysema, demonstrating a significant increase in the
patient's quality of life with improved pulmonary function and
exercise ability. ELEVATE is a prospective, multicentre,
randomised, controlled study to confirm these findings and further
identify disease characteristics using Quantitative Computed
Tomography (QCT) scans that determine which patients will respond
to Coil treatment. The ELEVATE study will recruit 210 patients with
severe emphysema from up to 30 experienced centres in 7 European
countries
David Hahn, MD, General Manager,
PneumRx BTG, said: "The ELEVATE study advances knowledge learned
from the RENEW study and uses the very latest in diagnostic
technology to help identify the patients most likely to benefit
from Coils. The first patient has been treated by Dr Dirk-Jan Slebos and his team at the University
Medical Center Groningen in the
Netherlands and we are excited to begin enrolment in the
study that will further demonstrate the effectiveness of Coils in
this patient population who have limited options in the treatment
of their disease."
Professor Felix Herth, Head of
the Department of Internal Medicine, Pulmonology and Critical Care
Medicine, at Thoraxklinik at Heidelberg University Hospital,
explains: "ELEVATE continues to build on the body of clinical
evidence for Bronchoscopy Lung Volume Reduction (BLVR) with Coils.
It will answer open questions and is designed to confirm patient
selection criteria for emphysema dominant patients. As the
Principal Investigator of ELEVATE, I am very positive about this
study, it will help to advance the therapy for the treatment of
severe emphysema to the next level."
Patients with severe emphysema might be eligible for the study.
If you are interested in learning more about this study, please see
the study description on clinicaltrials.gov NCS 03360396.
About PneumRx™ Endobronchial
Coils
The PneumRx™ Endobronchial Coils are minimally invasive medical
implants designed for the treatment of severe emphysema with
hyperinflation.
The shape-memory nitinol Coils are indicated for use in patients
with homogeneous and/or heterogeneous severe emphysema to improve
quality of life, lung function, and exercise capacity.
The PneumRx™ Endobronchial Coil System is used in conjunction
with a 2.8mm working channel therapeutic bronchoscope and
fluoroscopic imaging to introduce multiple Coils into the lungs
using a minimally invasive approach that requires no incision. When
implanted in sub-segmental airways of the lung, each nitinol Coil
is designed to: gather and compress damaged lung tissue, re-tension
the airway network, reduce airway collapse and air trapping, and
redirect air to healthier portions of the lung
About Published Trials
Three randomised controlled trials document the clinical
benefits of the PneumRx™ Endobronchial Coil System with an
acceptable safety profile.
Published clinical data is available concerning the treatment of
severe emphysema with PneumRx™ Endobronchial Coils. Three
randomised controlled trials (RCTs) with up to 12 months follow-up
and a total of more than 450 patients document a positive effect
and acceptable safety
profile.[1]-[3]
In these three RCTs (RESET[1],
REVOLENS[3] and
RENEW[2]) quality of life, lung
function and exercise capacity were improved to a statistically
significant degree by BLVR with Coils. In all three trials, the
primary endpoint was met and improvement was noted in all other
recorded parameters.
The patients' quality of life score improved by more than twice
the Minimal Clinically Important Difference (MCID) in all three
trials[4]. In the opinion of
experts, positive changes in the St. George's Respiratory
Questionnaire (SGRQ) score reflect the decrease in breathlessness
in daily life. The FEV11values increased after BLVR with
Coils in comparison to control patients, while lung RV
decreased.
In addition to the RCTs, PneumRx, a BTG International group
company, has conducted several open label studies and supported
post-hoc analyses of the published data.
About BTG
BTG is a global healthcare company focused on Interventional
Medicine. Our innovative medical technology helps physicians treat
their patients through minimally invasive procedures. We have a
growing portfolio of products that advance the treatment of cancer,
vascular conditions and severe emphysema. BTG's Pharmaceuticals
business provides products that help patients overexposed to
certain medications or toxins. To learn more about BTG, please
visit: btgplc.com.
For further information contact:
BTG
Andy Burrows, VP Corporate &
Investor Relations
+44-(0)-20-7575-1741; Mobile: +44-(0)-7990-530-605
Stuart Hunt, Investor Relations
Manager
+44-(0)-20-7575-1582; Mobile: +44-(0)-7815-778-536
Chris Sampson, Corporate
Communications Director
+44-20-7575-1595; Mobile: +44-7773-251-178
FTI Consulting
Ben Atwell/Simon Conway
+44-(0)-20-3727-1000
References
[1] Shah PL et al. Lancet Respir
Med 2013;1:233-240.
[2] Sciurba FC et al. JAMA
2016;315:2178-2189.
[3] Deslee G et al. JAMA
2016;315:175-184.
[4] Jones PW et al. Eur Respir J
2002;19:398-404
SOURCE BTG plc