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SIBIA Neurosciences Reports Neuroprotective
Potential
of Neuronal Nicotinic Acetylcholine Receptor
Ligands
Presentation at 4th Annual Nicotine
Research Conference
Bryan Center, Duke University, Durham,
North Carolina
LA JOLLA, Calif., Nov. 4 /PRNewswire/ -- In a
presentation at Duke
University, scientists from SIBIA Neurosciences,
Inc. (Nasdaq: SIBI) reported
that preclinical studies of SIB-1508Y, one of the
Company's proprietary
neuronal nicotinic acetylcholine receptor (nAChR)
agonists, and currently in
Phase 2 clinical trials, has shown the ability to
substantially protect
neurons from degenerative changes in a rodent model
of Parkinson's disease.
Previous studies in rat and primate models of
Parkinson's disease
suggested that SIB-1508Y could offer a new approach
to treatment with distinct
advantages over existing Parkinson's disease
therapies because of its ability
to improve both cognitive and motor deficits. It is
now recognized that
cognitive impairment is a serious and frequent
symptom in many Parkinson's
patients, but no available product addresses this
aspect of the disease. The
animal data on neuroprotection suggests the
potential for this compound to
treat not only the cognitive and motor symptoms of
Parkinson's disease, but to
retard the degeneration of neurons, which is a
hallmark of the disease
process.
Human Parkinson's disease is characterized by
loss of the neurotransmitter
dopamine in the nigrostriatal pathway, resulting in
marked impairment of
movement and often accompanied by deficits in affect
and cognition. In the
studies reported by Tadimeti Rao, Ph.D., Associate
Research Director at SIBIA,
SIB-1508Y offered protection against the decrease in
dopamine levels in the
striatum and substantia nigra in rat models of
Parkinson's disease following
injection of a neurotoxin, 6-OHDA, into the rat
striatum. This type of lesion
damages dopamine neuron terminals in the striatum
and leads to a progressive
degeneration of the dopamine cell bodies in the
substantia nigra. The best
protection was seen when SIB-1508Y was given prior
to the 6-OHDA injection and
followed by continued administration over a period
of four weeks. In this
paradigm, SIB-1508Y was able to completely protect
against toxin-induced loss
of dopamine in the substantia nigra and protect up
to 75% of the dopamine loss
in the striatum. In addition, the repeated
administration of SIB-1508Y
increased levels of choline acetyltransferase, a
critical enzyme involved in
the synthesis of acetylcholine, an important
neurotransmitter for cognition.
SIBIA Neurosciences, Inc. is engaged in the
discovery and development of
novel small molecule therapeutics for the treatment
of neurodegenerative,
neuropsychiatric and neurological disorders, many of
which have large patient
populations and represent critical unmet medical
needs.
SIBIA Neurosciences Announces Results From Two Phase 2 Studies Of
SIB-1508Y for Parkinson's
Disease
LA JOLLA, Calif., July 21 /PRNewswire/ -- SIBIA Neurosciences, Inc.
(Nasdaq: SIBI) today announced results from two initial Phase 2 clinical
trials of SIB-1508Y (altinicline) in Parkinson's disease (PD) patients.
The first study, 201, was a parallel group, placebo controlled,
multiple
dose study over four weeks of oral dosing primarily to assess the safety
and
tolerability and secondarily the efficacy of altinicline against both
motor
and cognitive symptoms in early stage PD patients who were not currently
receiving dopaminergic therapy. In this study, a range of well
tolerated
doses was established with the dosing regimen used. Altinicline did not
demonstrate statistically significant improvement relative to placebo in
the
global analysis; however, an unusually high placebo response rate was
observed
in this trial. Despite this, altinicline, at a well-tolerated dose,
showed
improvement relative to baseline status, and in some cases to placebo,
in
certain motor and cognitive measures.
The second study, 202, was a crossover design examining acute motor
and
cognitive performance over an eight hour period in which later stage
patients
received either placebo or one of three doses of altinicline in random
order
along with half of their normally effective dose of L-DOPA on each of
four
treatment days. In this acute study, altinicline was not statistically
significantly different from placebo in the global analysis. However, a
trend
to significance was noted and significant differences between doses of
altinicline were observed, suggesting a dose-response effect. The study
also
demonstrated that later stage patients tolerated altinicline in the
presence
of L-DOPA.
Jeffrey McKelvy, Ph.D., SIBIA's Chief Scientific Officer, reported,
"In
these studies we found altinicline to be safe in the regimen used, and
we
defined tolerability over a broad dose range. Whereas statistical
significance was not observed, we believe that future studies are
warranted
based on the observed tolerability and the efficacy trends noted. These
data
will be valuable for the design of longer term studies of altinicline.
At
present, SIBIA intends that any future studies would be carried out by
corporate partners."
SIBIA Neurosciences, Inc. is engaged in the discovery and
development of
novel small molecule therapeutics for the treatment of
neurodegenerative,
neuropsychiatric and neurological disorders, many of which have large
patient
populations and represent critical unmet medical needs. [snip]
-------------------------------------------------
(Headline from website: www.sibia.com)
Aug-2-1999
Merck Acquires SIBIA Neurosciences, Inc., a California-Based
Biotechnology Firm; Acquisition Augments
Merck's Drug Discovery Program
-----------------------------------------
vbn6 wrote:
> Someone not subscribing to this list
> asked me to do a search but I can't come up
> with anything. Seems like all the studies
> are for Alzheimers not Parkinson's dementia.
> -------snip
> >>I need to find out if there are any current
> acetylcholinesterase inhibitor studies for PD
> *anywhere* Could you please help me?<<
> --------snip
> Archives has Aricept and Cognex posts but no
> specific studies mentioned. Any ideas?
>
> Thanks.
> Victoria Nordli cg
--
Charlotte Mancuso
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