[acb-hsp] FW: [Missouri-l] FW: Exciting News for Non-24 Sufferers!
paltschul at centurytel.net
Thu Jan 26 12:07:57 EST 2012
From: missouri-l-bounces at moblind.org [mailto:missouri-l-bounces at moblind.org]
On Behalf Of Denny Huff
Sent: Thursday, January 26, 2012 8:33 AM
Subject: [Missouri-l] FW: Exciting News for Non-24 Sufferers!
Initial Clinical Data Reveal Potential of Tasimelteon to Reset the Body
Clock In Non-24-Hour Sleep-Wake Disorder
ROCKVILLE, Md., January 26, 2012 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(NASDAQ: VNDA) announced today that tasimelteon was shown for the first time
to reset the body clock and to align it to a constant 24-hour day in
patients suffering from Non-24-Hour Sleep-Wake Disorder (Non-24-Hour
Disorder). Tasimelteon is a circadian regulator in development for the
treatment of Non-24-Hour Disorder in totally blind individuals with no light
This observation was made in four patients during the initial run-in segment
of the RESET study. RESET is a Phase III studyof the maintenance effect of
tasimelteon in the treatment of Non-24-Hour Disorder. Vanda intends to
enroll a total of 20 tasimelteon responders in this study.
"We are extremely excited by this finding as it provides us with evidence
that tasimelteon is able to reset the body clock in patients with
Non-24-Hour Disorder," said Mihael H. Polymeropoulos, MD, President and CEO
of Vanda Pharmaceuticals.
Circadian regulation is necessary for the treatment of Non-24-Hour Disorder
and it is predictive of a beneficial effect on both nighttime sleep and
daytime naps. While light resets the body clock in sighted individuals,
keeping it synchronized with the 24-hour day, this effect is lost in totally
blind individuals with no light perception.
Vanda is currently studying the efficacy of tasimelteon in Non-24-Hour
Disorder in two Phase III studies, SET and RESET, which are ongoing and
expected to be completed by the end of 2012.
About the RESET Study
RESET is a randomized withdrawal study designed to demonstrate the
maintenance effect of 20 mg tasimelteon in the treatment of Non-24-Hour
Disorder. Twenty totally blind individuals with no light perception and
diagnosed as having a body clock period ofgreater than 24 hours, will be
treated with tasimelteon for three months during a run-in phase. Patients
who respond to tasimelteon treatment during the run-in phase, as measured by
the resetting andalignment of their body clock to the 24-hour day, will then
be randomized either to receive placebo or to continue receiving tasimelteon
for 2 months. During the post-randomization phase,patients will be
re-evaluated. For more information, please visit http://clinicaltrials.gov.
About Non-24-Hour Disorder
Non-24-Hour Disorder is a chronic circadian rhythm sleepdisorder that
affects more than 50 percent of the totally blind individuals in the U.S.,
or 65,000 to 95,000 people. Non-24-Hour Disorder occurs almost entirely in
individuals who are totally blind and lack the light sensitivity necessary
to reset the circadian clock. Without light perception, the brain's
circadian rhythms,which guide many of the body's functions, including sleep,
are not reset to a regular 24-hour cycle.
Individuals with Non-24-Hour Disorder are unable to synchronize their
internal clock to the 24-hour day-night cycle, which disrupts their
sleep-wake cycle. For more information, please visit
Tasimelteon is the first compound in development for the treatment of
Non-24-Hour Disorder. Tasimelteon is a specific and potent agonist of the
human MT1 and MT2 receptors. Compounds that selectively bind to melatonin
receptors are thought to be able toregulate the body clock, which may be
useful to treat circadian rhythm disorders. Tasimelteon is being studied in
both Non-24 and Major Depressive Disorder (MDD).
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for central nervous system
disorders. For more on Vanda Pharmaceuticals Inc., please visit
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," or the negative of these terms 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 FanaptR receives; Vanda's ability to successfully commercialize
FanaptR outside of the U.S. and Canada; delays in the completion of Vanda's
clinical trials; a failure of Vanda's products, product candidates or
partnered products to be demonstrably safe and effective; Vanda's failure to
obtain regulatory approval for its products, product candidates or partnered
products or to comply with ongoing regulatory requirements; a lack of
acceptance of Vanda's products, product candidates or partnered 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 or product candidates; Vanda's failure to develop or
obtain sales, marketing and distribution resources and expertise or to
otherwise manage its growth; limitations on Vanda's ability to utilize some
or all of its prior net operating losses and research and development
credits; 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 or product candidates
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, 2010 which is on
file with the SEC and available on the SEC's website at www.sec.gov
<http://www.sec.gov/%20/t%20_blank> . 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.
Senior Communications Manager
Vanda Pharmaceuticals Inc.
Cristina.murphy at vandapharma.com
(212) 477-9007, extension 17
bmiles at bmccommunications.com
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