Memory Pharmaceuticals Initiates Phase 2a Trial for MEM 1414 in Asthma
December 18 2008 - 4:05PM
PR Newswire (US)
Study to Evaluate Proof-of-Concept for Company's Lead PDE4
Inhibitor MONTVALE, N.J., Dec. 18 /PRNewswire-FirstCall/ -- Memory
Pharmaceuticals Corp. (NASDAQ:MEMY) today announced that it has
enrolled its first patient in its double-blind, randomized,
placebo-controlled Phase 2a trial of MEM 1414 in asthma. MEM 1414,
the Company's lead molecule in its PDE4 inhibitor program, has
demonstrated positive effects in preclinical models of inflammation
and a favorable safety profile in multiple human clinical studies.
"MEM 1414 represents an ideal drug candidate for the potential
treatment of respiratory indications such as asthma and chronic
obstructive pulmonary disease, particularly given its safety
profile," stated Brian O'Connor, M.D. of the Heart Lung Centre in
London. "There is a strong rationale for the use of PDE4 inhibitors
in respiratory indications, but the emesis traditionally associated
with this drug class has limited their development. The data
suggests that MEM 1414 may be able to produce a robust
anti-inflammatory effect without emesis or nausea, and I look
forward to evaluating its potential in a clinical setting." In this
study, the efficacy of multiple doses of 600 mg of MEM 1414 on the
allergen-induced asthmatic response in steroid free subjects with
mild allergic asthma will be evaluated in comparison to placebo.
The Phase 2a trial will enroll approximately 16 subjects, who will
be randomized to receive either 600 mg of MEM 1414 or placebo each
day for seven days in a crossover design. Each subject will
participate in two one-week treatment phases, with a wash-out
period of 2 to 10 weeks between each treatment phase. An important
objective of the trial is to assess the efficacy of MEM 1414 on the
late asthmatic reaction (LAR) following an inhaled allergen
challenge, as measured by changes in Forced Expiratory Volume in 1
Second. Additionally, effects of MEM 1414 on cytokine biomarkers of
efficacy associated with the LAR, as well as effects on the early
asthmatic reaction following allergen challenge, will be assessed,
together with the safety and tolerability of the compound in this
patient population. "Our data for MEM 1414 overwhelmingly supports
development in a respiratory indication like asthma," stated Vaughn
M. Kailian, President and Chief Executive Officer of Memory
Pharmaceuticals. "This trial represents a significant milestone in
the development of MEM 1414 and provides the opportunity to
establish proof-of-concept in this important test of
anti-inflammatory efficacy." About MEM 1414 MEM 1414 is the lead
compound in Memory Pharmaceuticals' PDE4 inhibitor program. PDE4
inhibitors are designed to inhibit the activity of PDE4, an enzyme
which breaks down cAMP, and these compounds may have therapeutic
utility in multiple indications, including Alzheimer's disease,
schizophrenia, respiratory disease and drug abuse. MEM 1414 has
demonstrated efficacy in a broad range of preclinical cognition and
anti-inflammatory models. In addition, multiple Phase 1 studies
have demonstrated a favorable safety profile for the compound
overall and particularly with respect to nausea and vomiting, which
has limited the development of other PDE4 compounds. About the
Company Memory Pharmaceuticals Corp., a biopharmaceutical company,
is primarily 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. The Company is
also exploring the potential of its pipeline to address additional
indications, such as respiratory diseases or obesity. 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, for Memory
Pharmaceuticals Corp. Web Site: http://www.memorypharma.com/
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