Memory Pharmaceuticals Initiates Biomarker Study of R3487/MEM 3454 in Schizophrenia
24 12월 2008 - 8:05PM
PR Newswire (US)
MONTVALE, N.J., Dec. 24 /PRNewswire-FirstCall/ -- Memory
Pharmaceuticals Corp. (NASDAQ:MEMY) today announced that it has
dosed the first patient in its Phase 2 clinical study of the effect
of R3487/MEM 3454, a nicotinic alpha-7 partial agonist, on
electrophysiological biomarkers in patients with schizophrenia. The
study will evaluate the effect of four doses of R3487/MEM 3454 on
electrophysiological biomarkers (such as P50 sensory gating) that
have been shown to be closely associated with schizophrenia.
"Recent research suggests that nicotinic alpha-7 receptor agonists
may improve the abnormal electrophysiological responses associated
with schizophrenia. This trial will evaluate whether we can use
these responses as biomarkers to predict or assess the effects of
R3487/MEM 3454 in this patient population," stated Stephen Murray,
M.D., Ph.D., Chief Medical Officer of Memory Pharmaceuticals. "This
biomarker trial complements our ongoing Phase 2 trial of R3487/MEM
3454 in cognitive impairment associated with schizophrenia, and we
look forward to reporting the results in the third quarter of
2009." The double-blind, placebo-controlled biomarker study will
enroll 12 non-smoking patients with stable schizophrenia who are
receiving certain types of antipsychotic drugs. Subjects will be
randomized to receive R3487/MEM 3454 and placebo in a 5-way
cross-over design. Each subject will participate in 5 treatment
periods. During each period, subjects will receive single doses of
either 1 mg, 5 mg, 15 mg, or 50 mg of R3487/MEM 3454 or placebo,
with a 4 to 10-day wash-out period between each treatment period.
The primary outcome of the trial is the effect of R3487/MEM 3454 on
P50 sensory gating and the potential utility of P50 as an efficacy
biomarker for nicotinic alpha-7 agonists in schizophrenia.
Secondary outcome measurements include additional
electrophysiological biomarkers, called mismatch negativity and
P300. The study is being funded by Roche under the companies'
nicotinic alpha-7 receptor agonist collaboration agreement. Evoked
Potentials in Schizophrenia Electrophysiology measures have long
been used to detect changes in brain activity in patients with
schizophrenia. These patients often have a diminished ability to
suppress the evoked response to the second of two auditory stimuli,
known as sensory gating. Studies have shown that this abnormality
is genetically linked to the nicotinic alpha-7 receptor and can be
measured through the P50 auditory evoked response, a waveform
measured 50 milliseconds after an auditory stimulus. Recent
scientific studies have shown that a nicotinic alpha-7 agonist can
improve both cognition and P50 inhibition, giving rise to the
possibility that P50 can be used to track cognitive effects for
this class of compounds. Other, similar measures abnormal in
patients with schizophrenia are mismatch negativity (the
pre-attentional response to a deviation from a repetitive auditory
pattern) and P300 (an attentional response to a deviation from a
repetitive auditory pattern). About R3487/MEM 3454 R3487/MEM 3454
is a partial agonist of the nicotinic alpha-7 receptor, a highly
specialized receptor found in the central nervous system, being
developed in partnership with Roche. In a Phase 2a study in
Alzheimer's disease patients, R3487/MEM 3454 demonstrated a
statistically significant effect on multiple measures of cognition.
The compound is currently being evaluated in a Phase 2 trial in
cognitive impairment associated with schizophrenia, with top-line
results expected by the end of April 2009. About the Company Memory
Pharmaceuticals Corp., a biopharmaceutical company, is focused on
developing innovative drugs for the treatment of debilitating CNS
disorders, many of which exhibit significant impairment of memory
and other cognitive functions, including Alzheimer's disease and
schizophrenia. For additional information, please visit our website
at http://www.memorypharma.com/. Safe Harbor Statement This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that are
subject to risks and uncertainties. All statements, other than
statements of historical facts, regarding management's
expectations, beliefs, goals, plans or Memory Pharmaceuticals'
prospects, future financial position, future revenues and projected
costs should be considered forward-looking. Readers are cautioned
that actual results may differ materially from projections or
estimates due to a variety of important factors, including the
outcome of clinical trials of Memory Pharmaceuticals' drug
candidates and whether they demonstrate these candidates' safety
and effectiveness; the risks and uncertainties associated with: the
possibility that the Company's acquisition by Roche will not be
completed, obtaining additional financing to support Memory
Pharmaceuticals' R&D and clinical activities and operations;
obtaining regulatory approvals to conduct clinical trials and to
commercialize Memory Pharmaceuticals' drug candidates; Memory
Pharmaceuticals' ability to enter into and maintain collaborations
with third parties for its drug development programs; Memory
Pharmaceuticals' dependence on its collaborations and its license
relationships; achieving milestones under Memory Pharmaceuticals'
collaborations; Memory Pharmaceuticals' dependence on preclinical
and clinical investigators, preclinical and clinical research
organizations, manufacturers and consultants; protecting the
intellectual property developed by or licensed to Memory
Pharmaceuticals; and Memory Pharmaceuticals' ability to maintain
listing on the Nasdaq Capital Market. These and other risks are
described in greater detail in Memory Pharmaceuticals' filings with
the Securities and Exchange Commission. Memory Pharmaceuticals may
not actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. Memory Pharmaceuticals disclaims any
intent or obligation to update any forward-looking statements as a
result of developments occurring after the date of this press
release. DATASOURCE: Memory Pharmaceuticals Corp. CONTACT: Jzaneen
Lalani, General Counsel, +1-201-802-7249 Web Site:
http://www.memorypharma.com/
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