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BÂRRX Medical, Inc. Initiates Landmark Study Comparing Two Treatment
Options for Barrett's Esophagus
AstraZeneca (NYSE: AZN), makers of NEXIUM® (esomeprazole magnesium),
co-sponsors first study of radio frequency ablation therapy vs. standard of
care for Barrett's
Sunnyvale, Calif. - March 20, 2006 - BÂRRX Medical, Inc. today
announced the initiation of a landmark human study titled "Ablation of
Intestinal Metaplasia Containing Dysplasia: a Multi- Center, Randomized, Sham-Controlled
Trial." The AIM Dysplasia Trial will compare the effectiveness of the
HALO System against the current standard of care
for Barrett's esophagus, which includes regular endoscopic biopsy surveillance
and appropriate medical management of associated acid reflux disease (also called
GERD). Barrett's esophagus, often caused by chronic GERD, is a pre-cancerous
change to the lining of the esophagus that affects approximately three million
U.S. adults. Barrett's sufferers are at increased risk for developing a dangerous
type of cancer called esophageal adenocarcinoma, currently the fastest growing
cancer in the U.S. The study is the first to compare radio frequency (RF) ablation
therapy against the current standard of care for the treatment of Barrett's
esophagus.
The study has a planned enrollment of 120 patients diagnosed with Barrett's
esophagus with dysplasia (abnormal cells) - either low-grade or high-grade -
at 16 U.S. medical centers. The randomized, sham-controlled trial will assign
patients in a 2:1 ratio to receive either an endoscopic ablation procedure using
the HALO System or a similar procedure in which
no ablation is delivered (sham). Patients will not be aware of which procedure
they receive and will undergo follow-up with endoscopy and biopsy over the ensuing
12 months with comparison of the treatment results at each time interval. All
patients will receive esomeprazole magnesium (NEXIUM) as therapy for acid reflux
disease as part of the study protocol. The study hypothesis, based on available
data from other trials, is that a significantly greater proportion of treatment
patients versus sham-control patients will be completely free of Barrett's esophagus
at follow-up. After one year, patients who received ablation therapy continue
their follow-up for two full years, while patients who received
the sham-control procedure will undergo a "real" ablation procedure and will
be followed for two additional years.
Barrett's esophagus occurs when chronic acid reflux disease causes the cells
lining the esophagus to transform and undergo genetic changes that can set the
stage for cancer development. Barrett's has traditionally been managed with
frequent endoscopic biopsy surveillance to detect progression to cancer. However,
many physicians have long recognized the need to more proactively treat Barrett's
esophagus as opposed to watching and waiting for cancer to develop. Ablation,
the use of energy to remove the diseased layer of cells from the esophagus,
offers treatment for the disease before it has the opportunity to progress to
cancer. New healthy tissue replaces the ablated Barrett's tissue in three to
four weeks for most patients. "Barrett's esophagus is a serious disease
that can lead to esophageal adenocarcinoma, which has one of the poorest prognoses
of any human cancer," said Bergein F. Overholt, M.D., gastroenterologist
at Gastrointestinal Associates in Knoxville, Tennessee, and principle investigator
in the AIM Dysplasia Trial. "We have participated in several trials using
the HALO System, and have successfully treated
numerous patients. We are optimistic that this trial will provide additional
rigorous evidence that this device is a valid intervention for this disease
state." Dr. Overholt was the first physician to enroll patients in the
AIM Dysplasia Trial earlier this month.
About BÂRRX Medical, Inc.
BÂRRX Medical, Inc. develops treatment solutions for Barrett's esophagus,
a precancerous condition of the lining of the esophagus (swallowing tube) caused
by gastroesophageal reflux disease, or GERD. Its flagship product, the HALO
System, provides uniform and controlled therapy at a consistent depth, which
can remove Barrett's esophagus and allow the regrowth of normal cells. In the
largest study conducted (AIM-II Trial), 70% of patients were Barrett'sfree
(at one year follow-up). The system used in the clinical trials was cleared
by the U.S. Food and Drug Administration in 2001 and has been commercially available
since January 2005. Based in Sunnyvale, Calif., BÂRRX Medical, Inc. was
founded in 2000 and is privately-held. Additional information about BÂRRX
Medical, Inc. and the HALO System is available
at www.barrx.com.
About the HALO System
The BÂRRX Medical HALO System is the first
of a new generation of ablation tools that provides uniform and controlled ablative
therapy at a consistent depth to remove the layer of the diseased esophageal
tissue allowing replacement by normal cells. The procedure, which in clinical
studies had a median procedure time of 26 minutes, is performed without incisions
using conscious sedation in an out-patient setting. First, a physician uses
a HALO sizing balloon catheter to dilate the esophagus
and determine its inner diameter. A correctly sized ablation catheter is then
inflated within the diseased area of the esophagus. The HALO
energy BÂRRX Medical, Inc. Initiates Study Comparing Two Treatment Options
for Barrett's Esophagus generator is activated to deliver a rapid (less than
one second) burst of ablative energy, which removes a very thin (less than one
millimeter) layer of the diseased esophagus. Controlled delivery of energy avoids
injury to normal, healthy underlying tissues. New healthy tissue replaces the
ablated Barrett's tissue in three to four weeks for most patients, according
to trial results. Minor discomfort, which may be experienced by some patients,
has been managed in the trials with medication. Following ablation therapy,
patients resume acid suppression therapy.
About NEXIUM (esomeprazole magnesium)
NEXIUM is indicated for treating frequent, persistent heartburn and other
symptoms associated with acid reflux disease. NEXIUM is approved for healing
and maintenance of erosive esophagitis. Most erosions heal in 4 to 8 weeks.
Individual results may vary, and only a doctor can determine if erosions to
the esophagus have occurred. Symptom relief does not rule out the existence
of other serious stomach conditions. NEXIUM is also indicated for reducing the
risk of gastric (stomach) ulcers developing among at-risk patients on continuous
NSAID therapy. Patients are considered to be at risk if they are 60 and over,
or if they have a history of previous stomach ulcer. The most frequently reported
adverse events with NEXIUM include headache, diarrhea, and abdominal pain. For
full prescribing information for NEXIUM please visit www.purplepill.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research,
development, manufacture and marketing of prescription pharmaceuticals and the
supply of healthcare services. It is one of the world's leading pharmaceutical
companies with healthcare sales of $23.95 billion and leading positions in sales
of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection products. In the United States, AstraZeneca is a $10.77 billion healthcare
business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com
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