ROCKVILLE, Md., Aug. 26 /PRNewswire-FirstCall/ -- Vanda
Pharmaceuticals Inc. (Nasdaq: VNDA), today announced it has
initiated a Phase III clinical trial to evaluate tasimelteon in
patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a
condition experienced primarily by totally blind individuals that
results in abnormal night sleep patterns and chronic daytime
sleepiness. Tasimelteon binds to high affinity melatonin
receptors located in the brain that are believed to regulate
circadian rhythms, or sleep/wake cycles.
"Blind individuals with no light perception do not receive
external light and darkness signals that synchronize our internal
body clocks," commented Mihael H.
Polymeropoulos, M.D. President and Chief Executive Officer
of Vanda. "As a result, these individuals can live lives in a
constant state of circadian misalignment. Tasimelteon has the
potential to be the first in the class of circadian regulators,
drugs that may offer clinical benefits to patients with aberrant
timing of the sleep/wake cycle."
About Study VP-VEC-162-3201
Vanda Study 3201 is designed to
investigate the efficacy and safety of 20 mg tasimelteon versus
placebo in totally blind individuals with N24HSWD, with a target
enrollment of 160 individuals. The study includes a 6-month
treatment period and an optional open-label extension. The primary
endpoint of the study is improvement in Total Sleep Time (TST)
during the night. The study will also measure parameters of
daytime sleep and laboratory measures of the synchronization
between the internal body clock and the 24-hour environmental
light/dark cycle. Vanda expects to report top-line results for this
trial in the fourth quarter of 2011.
For more information about the clinical study please visit:
http://www.vandapharma.com/tasi3201.html
Non-24-Hour Sleep Wake Disorder (N24HSWD)
N24HSWD is an orphan indication affecting approximately 65,000
to 95,000 in the U.S. and 140,000 in Europe. N24HSWD occurs when individuals,
primarily blind with no light perception, are unable to synchronize
their endogenous circadian pacemaker to the 24-hour light/dark
cycle. Without light as a synchronizer, and because the
period of the internal clock is typically a little longer than 24
hours, individuals with N24HSWD experience their sleep/wake cycles
drifting later and later each day. Individuals with N24HSWD
have abnormal night sleep patterns, accompanied by difficulty
staying awake during the day. N24HSWD leads to significant
impairment, with chronic effects impacting the social and
occupational functioning of these individuals.
The ultimate treatment goal for individuals with N24HSWD is to
lock or synchronize their circadian rhythms into an appropriate
phase relationship with the 24-hour day so that they will have
increased sleepiness during the night and increased wakefulness
during the daytime.
Tasimelteon
Tasimelteon is a circadian regulator which binds to two high
affinity melatonin receptors, Mel1a (MT1R) and Mel1b (MT2R).
These receptors are found in high density in the
suprachiasmatic nucleus of the brain (SCN) which is responsible for
synchronizing our sleep/wake cycle. Tasimelteon has been
shown to improve sleep parameters in prior clinical studies, which
simulated a desynchronization of the circadian clock.
Tasimelteon has so far been studied in more than 900
individuals and has shown a good tolerability profile.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company
focused on the development and commercialization of clinical-stage
products for central nervous system disorders. For more on Vanda,
please visit http://www.vandapharma.com.
Cautionary Note Regarding Forward-Looking Statements
Various statements in this release are "forward-looking
statements" under the securities laws. Words such as, but not
limited to, "believe," "expect," "anticipate," "estimate,"
"intend," "plan," "targets," "likely," "will," "would," and
"could," and similar expressions or words, identify forward-looking
statements. Forward-looking statements are based upon current
expectations that involve risks, changes in circumstances,
assumptions and uncertainties. Important factors that could
cause actual results to differ materially from those reflected in
the company's forward-looking statements include, among others: the
extent and effectiveness of the development, sales and marketing
and distribution support Fanapt® receives; Vanda's inability to
utilize a substantial portion of its prior net operating losses and
research and development credits; Vanda's ability to successfully
commercialize Fanapt® outside of the U.S. and Canada; delays in the completion of Vanda's
clinical trials; a failure of Vanda's products to be demonstrably
safe and effective; Vanda's failure to obtain regulatory approval
for its products or to comply with ongoing regulatory requirements
for its products; a lack of acceptance of Vanda's products in the
marketplace, or a failure to become or remain profitable; Vanda's
expectations regarding trends with respect to its costs and
expenses; Vanda's inability to obtain the capital necessary to fund
additional research and development activities; Vanda's failure to
identify or obtain rights to new products; Vanda's failure to
develop or obtain sales, marketing and distribution resources and
expertise or to otherwise manage its growth; a loss of any of
Vanda's key scientists or management personnel; losses incurred
from product liability claims made against Vanda; a loss of rights
to develop and commercialize Vanda's products under its license and
sublicense agreements and other factors that are described in the
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of Vanda's
annual report on Form 10-K for the fiscal year ended December 31, 2009 and quarterly reports on Form
10-Q for the fiscal quarters ended March 31,
2010 and June 30, 2010, which
are on file with the SEC and available on the SEC's website at
www.sec.gov. In addition to the risks described above and in
Vanda's annual report on Form 10-K and quarterly reports on Form
10-Q, other unknown or unpredictable factors also could affect
Vanda's results. There can be no assurance that the actual
results or developments anticipated by Vanda will be realized or,
even if substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Therefore, no
assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is
provided only as of the date of this release, and Vanda undertakes
no obligation, and specifically declines any obligation, to update
or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
SOURCE Vanda Pharmaceuticals Inc.
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