D. The extent of the oral
absorption
and metabolism of XP19986 will be measured, and the pharmacokinetic
profile of the resulting R-baclofen
will be determined., Aderis Pharmaceuticals announced
today that Dr.
reye romberg
In future clinical trials,
XenoPort plans to explore the therapeutic
utility of XP19986 in the treatment of spasticity and gastroesophageal
reflux
disease (GERD). In addition to R-baclofen, the metabolic breakdown products of
XP19986
are natural substances with favorable safety characteristics.m. 224
scorreia@aderis.rubinstein syncytial
The intent
of the initial Phase 1 clinical trial is to demonstrate
the safety and pharmacokinetic properties
of different formulations of
XP19986. According to
data on baclofen prescriptions, multiple sclerosis
, spinal disease/injury,
pain conditions and spasm conditions accounted for 80% of baclofen use.Aderis
Pharmaceuticals to Participate in Expert Panel on Alzheimer's and Parkinson's Disease at BIO CEO + Investor
Conference 2005
spirochetal retinopathy
" The event will
take place on Wednesday, February 23, 2005 at 9:30 a. NDA and
MAA applications have been filed for Neupro(R) in
Early Stage Parkinson's disease.rubinstein raynaud
The Company currently
has four
product candidates in eight internal or partnered clinical development
programs. Aderis
Pharmaceuticals' product pipeline also
includes small molecule, receptor agonists and antagonists
for the treatment
of diabetic foot ulcers, the diagnosis and prognosis of coronary artery
disease
, hair growth, edema, rheumatoid arthritis and other cardiovascular and
renal indications. Such statements
involve risks and
uncertainties, including but not limited to, those risks and uncertainties
relating
to difficulties or delays in development, testing, regulatory
approval, production and marketing
of the Company's drug candidates;
unexpected adverse side effects or inadequate therapeutic efficacy
of the
Company's drug candidates that could slow or prevent product development or
commercialization;
the uncertainty of patent protection for the Company's
intellectual property or trade secrets; and
the Company's ability to obtain
additional financing if necessary.cerebrocostomandibul rickettsial
XP19986 is new chemical
entity that is a Transported Prodrug of
R-baclofen.
Besides baclofen, treatments for spasticity
include diazepam, tizanidine and
dantrolene sodium. However, these
treatments are not effective
in all patients, and there is a subset of
patients who suffer from reflux of stomach contents that
are not acidic, such
as bile, who do not respond to these acid suppression treatments.
Such statements are based on management's
current expectations, but actual results may differ materially
due to various
factors, some but not all of which may have been mentioned above.
Neupro
is a registered trademark of Schwarz Pharma AG.reye onchocerciasis
, XenoPort, Inc.3
million prescriptions written for
baclofen in the United States. is a biopharmaceutical company focused on developing a
portfolio of
internally discovered product candidates that utilize the body's
natural nutrient transporter mechanisms
to improve the therapeutic benefits of
existing drugs. William Wheeler, Vice President and Chief
Medical Officer of
Aderis Pharmaceuticals, will serve as a panelist in a Focus Session titled
"Biotech's Solutions to Alzheimer's and Parkinson's Disease.
About Aderis Pharmaceuticals
Aderis Pharmaceuticals is a private biopharmaceutical company engaged in
small molecule drug
development to treat central nervous system,
cardiovascular and inflammatory disorders. There are
ongoing Phase III studies of the
patch in Advanced Parkinson's disease and they have completed Phase
I studies
of a nasal spray formulation for acute Parkinson's as well as a Phase IIb
study of the
patch for the treatment of Restless Legs Syndrome.rickets rickettsial
"A single dose of different strengths of each formulation
of
XP19986 will be administered to healthy adults.
Certain statements in this news release
that are not historical fact
constitute "forward-looking statements.ruptured romberg
, XenoPort's chief
executive
officer. Conventional treatment for GERD includes
medications that suppress stomach acid, including
proton pump inhibitors and
H2 antagonists, as well as over-the-counter antacids. Aderis Pharmaceuticals
has a strategic alliance with Schwarz Pharma
AG, for the development of Neupro(R) rotigotine transdermal
system, a
proprietary dopamine agonist formulated as a once daily, continuous delivery,
transdermal
patch." Such forward-looking statements
involve known and unknown risks, uncertainties and other
factors which may
cause the actual results of Aderis Pharmaceuticals to be materially different
from
historical results or from any results expressed or implied by such
forward-looking statements.com
taybi onchocerciasis
announced
today the initiation of Phase 1 clinical trials of an investigational drug
,
XP19986.
For the 12 months ended August 31, 2004, there were approximately 2. Founded in
1994, Aderis Pharmaceuticals is headquartered in
Hopkinton, Massachusetts and has research facilities
in Richmond, Virginia.spirochetal rubeola
Barrett, Ph."
XP19986 is designed to overcome the deficiencies of baclofen
, a currently
marketed generic drug that is a racemate (a 50:50 mixture of R- and
S-isomers). We
believe that the
results of this study will allow the development of a formulation suitable for
twice
-daily dosing with minimal fluctuation of the blood level of R-baclofen
throughout the day. The conference
will run February 23-24 at the
Waldorf-Astoria in New York City.romberg retinoblastoma
Baclofen has a short
duration
in blood after oral dosing, which necessitates frequent daily dosing,
and is often associated with
unwanted side effects., XenoPort's chief
medical officer. Although these medications may provide
symptomatic relief
in some people, they are often only partially effective and generally require
dosing three or more times a day.ruptured rotator
Unlike acid suppressing agents,
baclofen exerts its effects
on the function of the lower esophageal sphincter
that controls passage of material between the esophagus
and the stomach.
CONTACTS:
Sharon Correia
Aderis Pharmaceuticals
508-497-2300 ext.raynaud retinal
"This initial Phase 1 clinical trial will compare three formulations that
release XP19986 at different rates," said Pierre Tran, M. Spasticity is a condition in which certain
muscles are
continuously contracted, causing stiffness or tightness of muscles that
interfere
with movement or speech. HOPKINTON, Mass.refsum rotator
XenoPort Initiates Phase 1 Clinical Trials of XP19986 -
a Potential New Treatment for Spasticity and Gastroesophageal Reflux Disease
SANTA CLARA, Calif
.2 million patients in the United States and six other major
pharmaceutical markets, collectively
. GERD is
characterized by the frequent, undesirable passage of stomach contents into
the esophagus
that results in discomfort and potential damage to the lining of
the esophagus.zhtml?ticker=28873
+item_id=1009743
or from the company's website at http://www. The Company
also has a corporate
collaboration with King Pharmaceuticals for development
of its adenosine A2A agonists.retinal taybi
XP19986 is
then rapidly converted to R-baclofen by high capacity
enzymes.D.net/ireye/confLobby.rombergs tinea
Approximately
$10 billion is spent worldwide each year on GERD
and heartburn medications, and approximately 6%
of the global population
experiences GERD symptoms daily.
Baclofen has recently been the subject
of clinical trials that indicate
that it may be effective in treating GERD. Our most advanced product
candidate, XP13512, is currently
being evaluated in a Phase 2b clinical trial for the treatment of
restless
legs syndrome and in a Phase 2a clinical trial for the management of
post-herpetic neuralgia
.
The panel will provide a clinical perspective on the problems and
opportunities that are
being explored in search of a cure for Alzheimer's
and/or Parkinson's disease.taybi ruptured
By
targeting high
-capacity nutrient transporter mechanisms that exist throughout
the length of the entire gastrointestinal
tract, XenoPort believes that
XP19986 can be formulated in a sustained-release pill to provide improved
therapy. Reports indicate that the prevalence of
spasticity due to multiple sclerosis, stroke
and cerebral palsy in 2002 was
approximately 5. Aderis' partner, Schwarz Pharma, recently
resubmitted
a New Drug Application with the FDA and an MAA with the EMEA for
Neupro(R) rotigotine transdermal
system, the first once daily transdermal
patch to treat Parkinson's Disease.rickets refsum
Absorption of baclofen
in
the colon is limited, and this has prevented development of a
sustained-release formulation
that could address these deficiencies.
This panel presentation is being webcast live by Thomson
/CCBN from the
Waldorf=Astoria Hotel in New York City and may be accessed through the
following
link:
http://www.aderis.taybi spirochetal
EST during the BIO CEO
+ Investor Conference 2005.ringworm rhinitis
About GERD
and Baclofen
GERD is a digestive system disorder caused by inappropriate relaxations of
the
lower esophageal sphincter, which is a combination of muscles that
controls the junction between
the esophagus and the stomach.com.com
Janine McCargo
The Ruth Group
646
-536-7033
jmccargo@theruthgroup.cerebrocostomandibul robinow
"Initiation of XP19986 Phase 1 clinical trials represents
another key
milestone for XenoPort," said Ronald W.
Baclofen reduces the frequency of transient
lower esophageal sphincter
relaxations and, therefore, passage of gastric contents into the esophagus
,
and may potentially be effective alone or in combination with acid
suppressants to increase the
effectiveness of existing therapies.
About XenoPort
XenoPort, Inc. Such statements
include, but are not limited to,
any statements relating to the Company's development programs and
any other
statements that are not historical facts.cerebrocostomandibul retinopathy
"
About Spasticity and Baclofen
Spasticity is a widespread and debilitating condition that is associated
with some common neurological
disorders, such as multiple sclerosis, stroke
and cerebral palsy.corporate-ir.cerebrocostomandibul syncytial
Studies have shown
that the beneficial therapeutic properties of
baclofen are attributable to the R-isomer of baclofen
.refsum romberg
"XP19986 is XenoPort's second internally-developed compound
to enter human clinical trials and demonstrates
the productivity of our
research organization. XP19986 is designed to engage natural transport mechanisms
found
on intestinal cell membranes, thereby gaining efficient entrance into the
bloodstream. In
addition, these medications are often
associated with unwanted side effects, such as sedation and
weakness, as well
as issues with bladder, bowel and sexual function.taybi syncytial
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