Broncus Reports Early EASE Trial Results for Airway Bypass With Exhale(R) Drug-Eluting Stents
© Marketwire 2009
18.11.2009 00:51:02
|
|
technology company focused on developing and commercializing innovative
solutions for lung diseases, is announcing early results of the EASE
(Exhale Airway Stents for Emphysema) Trial, the first ever, double-blinded,
randomized, sham-controlled device study for patients with emphysema/COPD.
The EASE Trial, which was designed to evaluate the safety and effectiveness
of the Airway Bypass procedure with Exhale Drug-Eluting Stents, did not
meet the 6 month co-primary endpoints of improving forced vital capacity
(FVC) and modified Medical Research Council (mMRC) dyspnea score when
compared to controls, though mMRC alone did show statistically significant
improvement.
Trial results demonstrated strong proof of Airway Bypass' mechanism of
action. Analysis of those subjects who met the co-primary endpoints showed
that a residual volume (RV) reduction greater than 500mL is a key predictor
for success. RV reductions greater than 500mL post-treatment and at 1
month, correlated with statistically-significant improvements in multiple
pulmonary function and emphysema symptom endpoints. More than 40% of
treated subjects achieved this degree of RV reduction post treatment.
Treatment effects were not significant if the initial RV reduction was less
than 500mL. The Company is actively analyzing the EASE Trial database and
CT data to optimize procedural success.
"While we are disappointed that we did not win both of the co-primary
endpoints of this trial, we are pleased to see the significant long term
improvement in mMRC and the RV subset data, both of which corroborate the
mechanism of action of Airway Bypass. We expect this rich and growing data
set, along with our LungPoint(TM) Virtual Bronchoscopic Navigation system,
will help us further improve the Airway Bypass treatment algorithm," said
Cary Cole, President and CEO of Broncus Technologies.
Airway Bypass is a minimally-invasive bronchoscopic procedure designed to
reduce lung hyperinflation (RV) and shortness of breath, the clinical
hallmarks of emphysema/COPD. During the procedure, new openings are created
in the airway walls, which then connect the damaged lung tissue to the
natural airway. By bypassing the collapsed airways, air that was trapped
has a way to exit the lungs. The Exhale Drug-Eluting Stent is designed to
support these extra-anatomic pathways.
Participants in the EASE Trial were randomized two-to-one into treatment
and control groups. While subjects in the treatment group received the
Airway Bypass procedure, the control group underwent bronchoscopy but did
not receive the stents. The prospectively-defined clinical endpoints were
Forced Vital Capacity (the amount of air that can be exhaled in a single
breath) and the modified Medical Research Council score, a measure of the
impact of breathlessness on quality of life. Six months after treatment,
participants who had clinically significant improvements in both these
measurements were considered a responder. The responder rates for the
treatment and control groups were then analyzed for statistically
significant difference. 315 patients were enrolled at more than 40 leading
lung centers worldwide. Post hoc analysis is ongoing to determine stent
placement patterns associated with improved pulmonary and functional
outcomes.
About Emphysema
Emphysema, a component of COPD, is a chronic, progressive, and irreversible
lung disease characterized by the destruction of lung tissue. The loss of
the lungs' natural elasticity and the collapse of airways in the lung
combine to make exhalation ineffective, leaving emphysema sufferers with
hyperinflation because they are unable to get air out of their lungs.
Breathing becomes inefficient and patients have to work very hard just to
breathe -- making normal activities, like walking, eating or even bathing,
difficult. There are currently no medical devices approved for the
treatment of patients with homogeneous emphysema, who constitute the
majority of emphysema patients. The only treatment option available to them
is lung transplantation, which is associated with a high morbidity and
mortality.
About Broncus Technologies, Inc.
Broncus Technologies is a medical technology company focused on developing
and commercializing innovative solutions for lung diseases. With our
LungPoint(TM) Virtual Bronchoscopic Navigation system, physicians can plan
bronchoscopic procedures and navigate to locations in the lungs accurately
and quickly. Our line of Yield(TM) catheters are used to obtain biopsy
samples and detect blood vessels. Our patented treatment method, Airway
Bypass using Exhale® Drug-Eluting Stents, is being investigated to
determine if it can provide the first minimally-invasive treatment option
for homogeneous, or diffuse, emphysema, the form of the disease experienced
by the majority of emphysema patients. For more information visit
www.broncus.com : www.broncus.com .
Editors Notes
For more information on the EASE Trial or Broncus Technologies, please
contact Meghan Oreste at 617-823-1441 or moreste@comcast.net : mailto:moreste@comcast.net .
