- Establishes Plan for Biomarker Study -
MONTVALE, N.J., Feb. 19 /PRNewswire-FirstCall/ -- Memory Pharmaceuticals
Corp. (Nasdaq: MEMY) today announced that it plans to conduct a clinical study
of MEM 3454, the Company's lead nicotinic alpha-7 partial agonist, on two
biomarkers of schizophrenia, P50 sensory gating and mismatch negativity, in
patients with schizophrenia. The biomarker study, and additional formulation
and manufacturing activities for MEM 3454, will be funded by Roche, under the
companies' collaboration for the development of nicotinic alpha-7 receptor
agonists.
"This new study will greatly enhance our ability to measure and predict
the efficacy of MEM 3454 and other compounds in the nicotinic alpha-7 receptor
program," said Stephen Murray, MD, Ph.D, Chief Medical Officer of Memory
Pharmaceuticals Corp. "The study should be underway this summer with data
available by early 2009. The biomarker data, together with the results of our
ongoing Phase 2a study in CIAS, will help with the design of later-stage
trials in schizophrenia."
The biomarker study will enroll approximately 12 patients with stable
schizophrenia who are receiving atypical antipsychotic therapy. Subjects will
be randomized to receive 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 1 mg, 5 mg, 15 mg, or 50 mg of MEM 3454
or placebo, with a 4-day wash-out period between each treatment period. The
primary objective of the trial is to study P50 sensory gating and mismatch
negativity as potential efficacy biomarkers for nicotinic alpha-7 agonists,
such as MEM 3454, in schizophrenia. P50 sensory gating and mismatch
negativity are two neurophysiological measurements that have been shown to be
closely associated with nicotinic alpha-7 function and schizophrenia.
In November 2007, Memory Pharmaceuticals announced positive Phase 2a data
from a clinical trial of MEM 3454 in Alzheimer's disease. MEM 3454
demonstrated a statistically significant effect on cognition at the 5 mg and
15 mg doses on both the primary and key secondary endpoints for that trial.
Roche has an option to a worldwide, exclusive license to develop and
commercialize MEM 3454 upon the delivery by Memory of the study report of the
Phase 2a AD study and the fulfillment of certain additional predefined events.
Roche is obligated to make a milestone payment to Memory Pharmaceuticals at
the time this option is exercised.
In December 2007, as part of the development program for MEM 3454 in
schizophrenia, Memory Pharmaceuticals commenced a Phase 2a clinical trial of
MEM 3454 in CIAS. To maintain its license to MEM 3454, Roche would have to
make an additional milestone payment to the Company upon completion of the
ongoing Phase 2a CIAS trial, which is expected to be completed in the fourth
quarter of 2008.
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, which is known as sensory gating. A number of both
preclinical and clinical 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 positive waveform measured 50
milliseconds after an auditory stimulus. Recent scientific studies have shown
that a nicotinic alpha-7 agonist can both improve cognition and improve P50
inhibition, giving rise to the possibility that P50 can be used to track
cognitive effects for this class of compounds. Another auditory
electrophysiology evoked potential measure that is abnormal in patients with
schizophrenia is mismatched negativity, which is the ability to detect a
deviation from a repetitive auditory pattern. Both of these evoked potential
abnormalities in schizophrenia have been shown to be reversed by treatment.
About MEM 3454
MEM 3454 is a partial agonist of the nicotinic alpha-7 receptor, a highly
specialized receptor found in the central nervous system. Compounds acting on
this receptor could be beneficial in the treatment of Alzheimer's disease and
schizophrenia, as well as other psychiatric and neurological disorders. MEM
3454 is being developed by Memory Pharmaceuticals under its Strategic Alliance
Agreement with Roche for the development of nicotinic alpha-7 receptor
agonists and is the Company's lead drug candidate from its nicotinic alpha-7
agonist program.
About the Company
Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on
developing innovative drugs for the treatment of debilitating CNS disorders
such as Alzheimer's disease, schizophrenia and depression. 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 risks and uncertainties
associated with: obtaining additional financing to support Memory
Pharmaceuticals' R&D and clinical activities and operations; the outcome of
clinical trials of Memory Pharmaceuticals' drug candidates and whether they
demonstrate these candidates' safety and effectiveness; 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; and protecting the intellectual property developed by or
licensed to Memory Pharmaceuticals. 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.
SOURCE Memory Pharmaceuticals Corp.
-0- 02/19/2008
/CONTACT: Jzaneen Lalani, General Counsel for Memory Pharmaceuticals
Corp., +1-201-802-7249, or Lilian Stern of Stern Investor Relations, Inc. for
Memory Pharmaceuticals Corp., +1-212-362-1200/
/Web site: http://www.memorypharma.com /
(MEMY)
CO: Memory Pharmaceuticals Corp.; Roche
ST: New Jersey
IN: HEA MTC BIO SPM
SU: TRI JVN
IF-HB
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6950 02/19/2008 06:05 EST http://www.prnewswire.com
