-Trial demonstrates use of Aspect’s EEG-based biomarker as an early
indicator of antidepressant treatment efficacy with potential to help
guide depression care-
NORWOOD, Mass.--(BUSINESS WIRE)--Sep. 11, 2009--
Aspect
Medical Systems, Inc. (NASDAQ: ASPM) today announced that two
companion articles highlighting results from the BRITE-MD (Biomarkers
for Rapid Identification of Treatment Effectiveness trial in Major
Depression) were published in the September issue of the journal Psychiatry
Research. The BRITE trial results demonstrate that Aspect’s
EEG-based Antidepressant Treatment Response (ATR) indicator is a
significant predictor of patient response and remission after one week
of treatment with the commonly prescribed antidepressant escitalopram.
Retrospective analysis of BRITE data also suggests that ATR has the
potential to positively impact depression treatment outcomes by helping
clinicians select the most effective antidepressant for each patient
early in their treatment.
“The publication of BRITE trial results is a major milestone in our
efforts to develop clinically useful biomarkers for predicting treatment
response in Major Depressive Disorder. The BRITE results demonstrate
that early changes in frontal EEG may help predict treatment outcome in
as short a time as one week after the start of medication. We are
hopeful that these results will be replicated by other researchers, and
that an EEG biomarker can be used to help clinicians improve the care of
patients suffering from depression,” said Andrew Leuchter, M.D.,
professor of Psychiatry at the Semel Institute for Neuroscience and
Human Behavior at UCLA, principal investigator for the trial, and chair
of Aspect’s Neuroscience Advisory Board.
The BRITE trial was conducted in collaboration with leading
investigators from nine facilities across the United States and enrolled
375 patients. Patient response was defined by researchers as a 50
percent improvement in depression symptoms as measured by the Hamilton
Depression Rating Scale (HAM-D) after seven weeks of treatment, and
remission was defined as recovery from depression (HAM-D <7) after seven
weeks of treatment. In the BRITE study, ATR at one week predicted
response and remission with 74 percent accuracy in subjects treated for
seven weeks with escitalopram, which was statistically significant.
Modeled study data also indicates that subjects who were ATR predicted
non-responders to escitalopram had better outcomes if they were
randomized to switch to bupropion, an antidepressant with a different
mechanism of action than escitalopram.
“BRITE study results suggest that ATR could potentially provide the
greatest clinical benefit for those patients who might be receiving a
medication that is unlikely to help them. Our results suggest that it
may be possible to switch these patients to a more effective treatment
quickly. This would help patients and their physicians avoid the
frustration, risk and expense of long and ineffective medication
trials,” said Leuchter. “Research has shown that depression patients who
do not get better with a first treatment attempt experience prolonged
suffering, are more likely to abandon treatment altogether from lack of
efficacy and may become more resistant to treatment over time.” An
estimated 15 million people in the United States experience a depressive
episode each year, and nearly 17 percent of adults will experience major
depression in their lifetime.
Data from a study at Massachusetts General Hospital (MGH) investigating
ATR as a predictor of treatment response was also recently published in European
Neuropsychopharmacology. The MGH study evaluated ATR in 82 major
depression patients receiving selective serotonin reuptake inhibitors
(SSRI), and venlafaxine, and showed that use of ATR after the first week
of antidepressant treatment may be predictive of treatment efficacy.
Continuing the ATR research effort, BRITE trial investigator Dr. Ian
Cook at UCLA received a significant grant from the National Institutes
of Mental Health to conduct a multi-year follow-on study of ATR called
the PRISE-MD study (Personalized Response Indicators of SSRI
Effectiveness in Major Depression). The PRISE-MD study will
prospectively evaluate the ability of ATR to predict response to
escitalopram as well as the clinical utility of ATR-directed treatment
with escitalopram or an alternate treatment with bupropion.
“There is now a growing body of literature supporting the potential role
of frontal EEG, and ATR specifically, in the management of patients with
major depression. We believe that the use of biomarkers such as ATR to
optimize treatment efficacy and efficiency is well aligned with the
objectives of current healthcare reform efforts,” said Nassib Chamoun,
President and CEO of Aspect Medical Systems. “The UCLA grant award helps
to validate the importance of this research and also cost-effectively
advances the ATR program. We will continue to explore the commercial
potential and partnership opportunities for ATR.”
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market leader in
brain monitoring technology. To date, the Company's Bispectral Index
(BIS) technology has been used to assess approximately 34 million
patients and has been the subject of more than 3,300 published articles
and abstracts. BIS technology is installed in approximately 78 percent
of hospitals listed in the July 2009 U.S. News and World Report
ranking of America's Best Hospitals and in approximately 74 percent of
all U.S. operating rooms. In the last twelve months BIS technology was
used in approximately 19 percent of all U.S. surgical procedures
requiring general anesthesia or deep sedation. Aspect Medical Systems
has OEM agreements with nine leading manufacturers of patient monitoring
systems. For more information, visit Aspect's Web site at http://www.aspectmedical.com.
Safe Harbor Statement
Certain statements in this release are forward-looking and may
involve risks and uncertainties, including statements with respect to
the potential ability of the Company’s brain assessment technology to
rapidly predict the effectiveness of antidepressant medications and
expedite the process of identifying effective antidepressant drug
therapy, the anticipated benefits of the BRITE trial and the
Company’s belief that it can develop a practical, easy-to-use brain
assessment device to help clinicians optimize care for patients
suffering from depression. There are a number of factors that could
cause actual results to differ materially from those indicated by these
forward-looking statements. For example, the Company may not be
able to successfully develop and/or obtain required regulatory approvals
for its products under development for the diagnosis, management and
treatment of neurological diseases, such as depression, achieve
widespread market acceptance of any such products that it may develop or
to compete with new products or alternative techniques that may be
developed by others. In addition, the Company may not achieve comparable
or confirmatory results in later trials, including its planned PRISE
trial, as those achieved in earlier studies. There are other factors
that could cause Aspect’s actual results to vary from its
forward-looking statements, including without limitation those set forth
under the heading “Risk Factors” in Aspect’s Annual Report on Form 10-K
for the year ended December 31, 2008 and Aspect’s Quarterly Report on
Form 10-Q for the fiscal quarter ended July 4, 2009, each as filed with
the Securities and Exchange Commission. In addition, any forward-looking
statements represent the Company’s views only as of the date of this
press release and should not be relied upon as representing the
Company’s views as of any subsequent date. While the Company may
elect to update forward-looking statements in the future, it
specifically disclaims any obligation to do so, even if its expectations
change. Therefore, you should not rely on these forward-looking
statements as representing the Company’s views as of any date subsequent
to the date of this press release.
Aspect, Bispectral Index and BIS are registered trademarks of Aspect
Medical Systems, Inc. All other trademarks, service marks and company
names are the property of their respective owners.
Source: Aspect Medical Systems, Inc.
Aspect Medical Systems
Emily Anderson, 617-559-7032
Media
Relations
eanderson@aspectms.com
