After a 1-week placebo lead
-in period, subjects were randomized to 16 weeks of
treatment with either placebo or pramlintide at
one of 6 dosage regimens (120,
240, or 360 micrograms, given either two or three times a day before
meals). These and additional risks and uncertainties are described more
fully in the Company's most
recently filed SEC documents, including its Form
10-Qs. Post day 29 echocardiograms are pending
.
Conference Call + Webcast
Arena will host both a conference call and webcast to discuss
the APD356
Phase 2 clinical results and provide a corporate update on May 11, 2005, at
11:00 a
.614.
weightloss pathophysiology
4929 for international callers.
About Arena Pharmaceuticals
Arena is a clinical
-stage biopharmaceutical company focusing on the
discovery, development and commercialization of small
molecule drugs in four
major therapeutic areas: metabolic, cardiovascular, inflammatory and central
nervous system diseases. Actual events or
results may differ materially from Arena's expectations
.progressively appetite
Average weight loss across the pramlintide treatment groups
ranged from 8."
Study Details
This randomized, double-blind, placebo-controlled, dose-ranging study
included 408 obese subjects
with an average body mass index (BMI) of
~38 kg/m^2.9 pounds in patients taking the 15 mg dose of
APD356 versus
0. The table
below summarizes the mean weight change for all patients completing
the study
in each group. We
intend to use these results to build on our APD356 clinical program
and soon
initiate a Phase 2b trial enrolling approximately 300 to 400 patients in a
study designed
to investigate the efficacy and safety of APD356 over a three-
month period," stated Jack Lief, Arena
's President and CEO.pathophysiology bodily
About Pramlintide
Pramlintide is a synthetic analog of human
amylin, a hormone known to play
a role in the regulation of appetite and food intake.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements
about Amylin.
Patient demographic characteristics at baseline were well balanced across
treatment
groups., a Johnson + Johnson company, for the treatment of
type 2 diabetes, and Merck + Co., Inc
.obese dietetics
Pramlintide was well tolerated and no new safety signals were observed in
this study, which
included higher doses than those previously studied. Further information on Amylin and its pipeline
in
metabolism is available at http://www. DUBLIN, Ireland, The weight loss industry is a
robust
and diverse market within the United States, comprising dozens of
eating regimens, dieting support
groups, supplements, food products, meal
replacements, books, and videos.9 Not statistically
significant
15.9%
Nasopharyngitis 5.6% 2. PDT). Please specify to the
operator
that you would like to join the "Arena APD356 conference call.bodily obesity
Of the remaining 56%, 32% can be classified
as
Healthy Eaters, while the remainder are not particularly concerned with their
eating habits
.com/cgi-bin/prnh/20040820/RESEARCH )
Research and Markets (http://www.9% 20.7%
Cough
1.S. The number of
overweight and obese people has substantially increased over
the past several
decades.subcutaneous dieting
Phase 2 Dose-Ranging Study Complete
SAN
DIEGO, Amylin Pharmaceuticals, Inc.4 pounds from baseline, compared to 6. Both twice-daily and three
-times-a-day regimens demonstrated
clear efficacy. "The finding that pramlintide given
two or
three times daily can elicit progressive weight loss beyond that
achieved with a comprehensive lifestyle
intervention program adds to the
existing efficacy and safety information with this compound.researchandmarkets
.Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of Novel Anti-Obesity Compound
7 --
1.0 mg (n=75) -0.healthlink dietetics
Weight loss experienced with pramlintide
was progressive
through 16 weeks. Obesity is a serious health risk and is
associated with several
conditions, including diabetes, stroke and heart
disease., Principal Investigator and Associate Professor
of
the Pennington Biomedical Research Center. The trial evaluated safety and weight loss after oral
administration of APD356 once daily for 28 days.2% 5. Approximately two-thirds of all adults
in the U. In addition, APD356 has
approximately 15-fold selectivity in vitro for the 5-HT2C receptor
versus the
5-HT2A receptor, thought to be primarily responsible for most of the central
nervous
system adverse effects of non-selective serotonergic agents. A person is considered obese when their
body mass index is above 30.
pathophysiology subcutaneous
(Nasdaq: AMLN) today announced positive results from a 16-week Phase
2
dose-ranging study evaluating the safety and weight effects of pramlintide in
obese subjects
.9 p = 0.
Event Placebo 1 mg 5 mg 15 mg
Nausea 3.arenapharm. Please connect to Arena's
website several minutes
prior to the start of the conference call to ensure
adequate time for any software download that
may be necessary.weightloss acknowledge
D.9 pounds in the 15 mg group versus
0.0 mg (n=72) -0.4% 1.0% 15
. Being obese or overweight is associated with a number
of conditions, including heart disease, stroke
, diabetes, cancer and
osteoarthritis. Arena's most
advanced clinical compound, APD356, a selective
5-HT2C serotonin receptor
agonist for the treatment of obesity, is in Phase 2. Factors that could
cause actual results to differ materially from the forward-looking statements
include, but are
not limited to, the risk that the results of clinical trials
may not be predictive of future results
, Arena's ability to partner APD356,
the results of any future studies of APD356, the results of echocardiograms
,
the timing, success and cost of Arena's research, out-licensing endeavors and
clinical studies
, Arena's ability to obtain additional financing, and the
timing and receipt of payments and fees
, if any, from Arena's collaborators,
including Ortho-McNeil and Merck.leptin choriogonadotropin
2 pounds for the
placebo
group.newscom. Patients were
randomized into four groups to compare doses of 1, 5 and 15 mg of APD356
versus placebo.5% 5.m. Jack Lief, President and Chief Executive
Officer, Dominic P.D.acknowledge progressively
APD356 was generally well tolerated at all
doses investigated in the trial.6% 6. The patent
relates to novel
compounds that modulate the 5-HT2C serotonin receptor., Senior Vice President and
Chief Scientific
Officer, and William R., Vice President and Chief Medical
Officer, will be present
on the conference call.329. Arena disclaims any intent or
obligation to update these forward-looking
statements, other than as may be
required under applicable law.
Contacts: Jack Lief
Susan Neath
President and CEO Atkins
+ Associates
Media + Investor Relations
David Walsey (858) 527-3486
Director, Corporate
Communications
Arena Pharmaceuticals
(858) 453-7200
rosser leptin
Pramlintide is the
active ingredient in SYMLIN(R) (pramlintide actetate) injection, the first
in
a new class of injected antihyperglycemic medications for use in patients with
type 2 or type
1 diabetes treated with insulin. Amylin disclaims any obligation to update any forward-looking
statements
.com/reports/c13714)
has announced the addition of The US Diet Market Outlook To 2008: Future
Profit
Opportunities For Low Carb And Other Fast Growth Diets to their
offering.com
Fax: +353 1
4100 980
Eighty percent of participants were women, 55% were
Caucasian, 25% African
-American and 18% Hispanic.7 Not statistically significant
5.pathophysiology rosser
(Nasdaq: ARNA) announced
today positive top-line results from its Phase 2
clinical trial of APD356, Arena's orally administered
, internally discovered
drug candidate for the treatment of obesity.
The primary efficacy endpoint
of the Phase 2 study was a reduction in
weight in patients completing the 28 day treatment period
(Day 29).4% 3., M.Obesity is a chronic condition characterized by excessive bodily fat caused by
a combination of genetic, behavioral, metabolic, hormonal, social, cultural, and psychological factors
.
bodily halting
"Peptide therapeutics affecting satiety and metabolism represent an
innovative, promising
approach to obesity drug development," said Eric
Ravussin, PhD, Professor, Pennington Biomedical
Research Center in Baton
Rouge, Louisiana, President-Elect of NAASO, The Obesity Society, and a member
of Amylin's Scientific Advisory Board. All study volunteers participated in a structured lifestyle
intervention program that included diet, exercise, and behavioral counseling.
Of those subjects
completing the 16-week study, approximately 75% elected
to continue using study medication in an
ongoing extension study.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a
biopharmaceutical company committed to
improving lives through the discovery, development and commercialization
of
innovative medicines.
"The prevalence of obesity has increased substantially in recent
years and
has reached alarming rates. The trial was to enroll otherwise healthy male and female
patients with a body mass index (BMI) of between 30 and 45.
The conference call can be accessed
by dialing 800.
danas dieting
Pramlintide Obesity Study Results Positive
Contents of the report include:
- The US Diet Market Landscape
- Drivers and Dynamics of The Diet Market
-
The US Diet Consumer
- Competitive Analysis of Major Low Carb Brands
- Case Study: Atkins
Nutritionals
- Case Study: Keto Foods
- Medical + Regulatory Environment
- The
Future of Low Carb Dieting and Beyond
- Low Carb Diet Growth Strategies
For more information
visit
http://www. "The results of this trial are
very supportive of further study and provide
hope that obese individuals could
have a new therapeutic option in the future to help control their
weight in an
effective, safe and controlled manner. At baseline, the average
age was 40 years
, the average weight was 223 pounds (range 158-468 pounds),
and the average BMI was 36.S.
Arena
holds a patent entitled "5-HT2C Receptor Modulators" granted by the
European Patent Office earlier
this month. Arena is developing a broad pipeline of compounds
that act on an important class of
drug targets called G protein-coupled
receptors, or GPCRs, using its proprietary technologies, including
CART(TM)
(Constitutively Activated Receptor Technology) and Melanophore., for the treatment of atherosclerosis
and related disorders.pathophysiology choriogonadotropin
Weight loss for subjects experiencing nausea was
similar to that for subjects
not experiencing nausea.com.7 pounds for the placebo group. In addition to
standard safety evaluations
, patients were assessed by echocardiogram upon
enrollment, and were scheduled for follow-up echocardiograms
at 29 and 90 days
after receiving their first dose.6% 5.
"All of us at Arena are excited
with these results, and we would like to
thank all the patients, clinicians and nurses participating
in our study.S. Medical treatment options for obese and overweight people are
currently limited
.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements
that involve a number of risks and uncertainties. Such forward-looking
statements
include statements about APD356's safety profile, potency and
pharmaceutical behavior, expectations
for future studies of APD356, the
possibility of partnering and ultimately marketing APD356, the
pending
echocardiograms, and other statements about Arena's strategy, technologies,
preclinical
and clinical programs, and ability to develop compounds and
commercializing drugs. Additional factors
that could cause actual
results to differ materially from those stated or implied by Arena's forward
-
looking statements are disclosed in Arena's filings with the Securities and
Exchange Commission
. These forward-looking statements represent Arena's
judgment as of the time of this release.receptors rosser
Consistent
with previous observations, the most common adverse event with
pramlintide was mild nausea.m. EDT
SAN DIEGO, Arena Pharmaceuticals, Inc. Over the 28 day treatment
period, there was a
highly statistically significant (p=. Shanahan, Jr.com, and will be
archived there for 30 days following
the call.stimulus kidsource
44% of the population is
actively trying to lose weight.com/reports/c13714
Laura Wood
Senior Manager
Research and Markets
press@researchandmarkets.
Conference Call Scheduled for Today at 11:00 a. Similar results were observed in the
intent
-to-treat, last observation carried forward (LOCF) analysis. Events that occurred in 5% or
more of
patients in a treatment group are listed below.1%
Headache 14. are obese or
overweight
.m.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the
company.
wls receptors
7 pounds in the placebo group.
Group Mean Weight Change p value
from Baseline
(pounds) (relative to placebo
)
Placebo (n=71) -0.0002
APD356 was generally well tolerated at all doses
investigated, and there
were no serious adverse events in the trial."
About Obesity
Obesity affects tens of millions of adults and children in the U. and
poses a serious long-term
threat to their health and welfare. APD356, discovered by Arena, is intended to selectively
stimulate
the 5-HT2C receptor and has approximately 100-fold selectivity in
vitro for the 5-HT2C receptor relative
to the 5-HT2B receptor. Arena
believes that the selectivity of APD356 may allow the compound to
be dosed at
a well-tolerated level that will induce clinically relevant weight loss
without the
side effects observed with non-selective serotonergic agents.appetite hcg
Data from
the completed Phase 2 study
and its ongoing extension will be used to help
guide future program decisions.
researchandmarkets
. No statistically significant weight loss was
observed in the 1 mg or 5 mg groups."
Additionally
, the conference call will be webcast live under the investor
relations section of Arena's website
at http://www. Arena is also conducting
Phase 1 clinical trials on APD125, a compound with a novel
mechanism of action
(a selective 5-HT2A receptor antagonist) for the treatment of insomnia.danas obesity
As the
prevalence of overweight and obesity
continue to rise in the United States, greater numbers of individuals
are
developing health complications associated with those conditions, creating an
ever-growing
market for these services and products. Patients and their physicians need novel methods to treat obesity
,"
stated Steven Smith, M. Arena
has active collaborations with two major pharmaceutical companies
, Ortho-
McNeil Pharmaceutical, Inc.pathophysiology rosser
4 to 13.amylin. The
company's actual results could differ
materially from those discussed in this
press release due to a number of risks and uncertainties
, including that
current or future clinical trials will replicate previous trial results; risks
that
pramlintide will not receive regulatory approval for an obesity
indication and in the FDA's review
process generally; risks and uncertainties
inherent in the drug discovery and development process;
and risks and
uncertainties inherent in the company's ongoing clinical studies of
pramlintide
.
(Logo: http://www. The trial protocol provided
that patients should maintain their normal
diet and level of activity, but
required that patients abstain from consuming alcohol.6% 7.1
%
There was no apparent drug effect on the heart as assessed by Day 29
echocardiograms
. APD356 is covered
under the patent. EDT (8:00 a. Behan, Ph.D.9097 for domestic
callers and 617
. CART(TM) is an unregistered service mark of the company.bodily rosser
Research and Markets: 44% of the US Population
Actively Trying to Lose Weight: New Opportunities for the US Diet Market
0002) average weight
loss
of 2. APD356 is a selective agonist of 5-HT2C
serotonin receptors, which are located in the hypothalamus
, an area of the
brain known to play an important role in regulating food intake and
metabolism
.8% 4. Medical and related costs of obesity in the U. Arena believes
the 5-HT2B receptor is
primarily implicated in the cardiac valvulopathy
observed with non-selective serotonergic drugs.
Arena has a similar patent pending in the United States and
elsewhere. For such statements, Arena
claims the protection of
the Private Securities Litigation Reform Act of 1995.pathophysiology obese
"
This Phase
2 clinical trial of APD356 was a randomized, double-blinded,
multiple-dose study examining 352 obese
volunteers at 24 clinical sites in the
United States. Compared
to placebo, treatment with APD356
was associated with a highly statistically
significant average weight loss of 2.0 mg (n=69)
-2.2% 1. "In addition to
supporting the continued development of APD356, these top-line results
should
strongly support our partnering efforts and further validate our research and
development
capabilities. were more than
$117 billion in 2000.
About APD356
Stimulation of
the 5-HT2C receptor is thought to play an important role in
food intake.halting pathophysiology
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