Company Press Release
SOURCE: SIBIA Neurosciences, Inc.
http://biz.yahoo.com/prnews/990721/ca_sibia_n_1.html
SIBIA Neurosciences Announces Results From Two Phase 2 Studies Of SIB-1508Y
for Parkinson's Disease
LA JOLLA, Calif., July 21, 1999 /PRNewswire/ -- SIBIA Neurosciences, Inc.
(Nasdaq: SIBI - news) 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. <SNIP>
Copyright © 1999 PRNewswire
--
Judith Richards, London, Ontario, Canada
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