Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals' Circadian Regulator Tasimelteon (VEC-162) Publis
02 12월 2008 - 9:01AM
PR Newswire (US)
ROCKVILLE, Md., Dec. 1 /PRNewswire-FirstCall/ -- Vanda
Pharmaceuticals Inc. (NASDAQ:VNDA) reports publication in The
Lancet, one of the world's leading medical journals, results of
clinical trials of its novel circadian regulator, experimental
compound tasimelteon (VEC-162). The publication by Rajaratnam et
al(1) is entitled "Melatonin agonist tasimelteon (VEC-162) for
transient insomnia after sleep-time shift: two randomised
controlled multicentre trials." Results are reported from two
clinical trials that demonstrate the sleep-promoting effects of
tasimelteon, a novel circadian regulator that acts by resetting the
body clock. The internal body clock is a complex molecular
machinery that governs the rhythm of many body functions, the most
well described of which is the sleep-wake cycle. In the same issue
of The Lancet, in an accompanying editorial, "Let there be sleep --
on time," Cardinali and Golombek(2) discuss the implications of the
circadian regulatory and sleep-promoting effects of tasimelteon.
They also point to the need for public health education and a move
towards more effective agents that do not present the safety issues
encountered with current sleep treatments. The article by
Rajaratnam et al(1) presents results from two clinical studies with
more than 400 volunteers, who were asked to initiate sleep five
hours before their usual bedtimes. Tasimelteon was shown to reset
the molecular machinery of the circadian clock and restore the
sleep-wake cycle by improving both the ability to initiate and to
maintain sleep as compared to placebo-treated patients. The body's
circadian clock plays significant roles in regulating sleep, mood
as well as cardiovascular and metabolic processes.(3)(4) Circadian
rhythm sleep disorders include insomnia associated with shift work
(overnight, rotating and early riser), travel across time zones,
delayed sleep phase syndrome, advanced phase syndrome and the
non-24-hour sleep-wake syndrome in the blind. These disorders
represent a large public health problem and, as presented in the
2006 Institute of Medicine (IOM) report on sleep disorders(5), the
annual economic impact of sleep problems due to night shift work
alone is estimated to exceed $65 billion. The novel circadian
regulator tasimelteon holds promise for the treatment of patients
with misalignments of the body clock. The work presented in The
Lancet examines the potential application in sleep disorders.
Additional clinical trials will have to be conducted to examine the
role of circadian regulators in the treatment of other disorders
such as depression, nondipper hypertension(3)(4), and others.
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. Vanda is
at an early stage of development and may not ever have any products
that generate significant revenue. Important factors that could
cause actual results to differ materially from those reflected in
the company's forward-looking statements include, among others:
delays in the completion of Vanda's clinical trials; a failure of
Vanda's product candidates to be demonstrably safe and effective;
Vanda's failure to obtain regulatory approval for its products or
to comply with ongoing regulatory requirements; a lack of
acceptance of Vanda's product candidates in the marketplace, or a
failure to become or remain profitable; Vanda's inability to obtain
the capital necessary to fund its research and development
activities; Vanda's failure to identify or obtain rights to new
product candidates; 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" section
(Part II, Item 1A) of Vanda's quarterly report on Form 10-Q for the
quarter ended September 30, 2008 (File No. 000-51863). In addition
to the risks described above and in Part II, Item 1A of Vanda's
quarterly report 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. (1) Rajaratnam, Shantha
M.W.; et al. "Melatonin agonist tasimelteon (VEC-162) for transient
insomnia after sleep-time shift: two randomized controlled
multicentre trials." http://www.thelancet.com/. 2008. (2)
Cardinali, Daniel P.; Golombek, Diego A. "Let There Be Sleep - On
Time." Letter. http://www.thelancet.com/. 1 December 2008. (3)
Bunney, Jennifer N.; Potkin, Steven G. "Circadian abnormalities,
molecular clock genes and chronobiological treatments in
depression." British Medical Bulletin. 2008; 86 (1): 23-32. (4)
Perez-Lloret, Santiago; Garcia Aguirre, Alejandro; Cardinali,
Daniel P.; Toblli, Jorge E. "Disruption of Ultradian and Circadian
Rhythms of Blood Pressure in Nondipper Hypertensive Patients."
Hypertension. 2004; 44: 311-315. (5) Colten, Harvey R.; Altevogt,
Bruce M. Institute on Medicine. Committee on Sleep Medicine and
Research. Sleep Disorders and Sleep Deprivation: An Unmet Public
Health Problem. 2006. DATASOURCE: Vanda Pharmaceuticals Inc.
CONTACT: Media, Cristina Murphy, , or Investor, Steven Shallcross,
, both of Vanda Pharmaceuticals Inc., Office, +1-240-599-4500 Web
Site: http://www.vandapharma.com/
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