Memory Pharmaceuticals Reports Phase 1 Data for R4996/MEM 63908
19 Dezember 2008 - 3:44PM
PR Newswire (US)
MONTVALE, N.J., Dec. 19 /PRNewswire-FirstCall/ -- Memory
Pharmaceuticals Corp. (NASDAQ:MEMY) today announced positive
results from its Phase 1 program for R4996/MEM 63908, a partial
agonist of the nicotinic alpha-7 receptor being developed in
collaboration with Roche for cognitive disorders such as
Alzheimer's disease. The Phase 1 program enrolled over 130 subjects
and included a single-ascending dose study, a food interaction
study, a study in elderly volunteers and a multiple ascending dose
study. The compound was generally safe and well-tolerated in all
four studies and achieved linear and dose-dependent plasma exposure
with a half-life suitable for once-daily oral dosing. "The results
of this Phase 1 program demonstrate that R4996/MEM 63908 is an
excellent candidate for further development," stated Vaughn M.
Kailian, President and Chief Executive Officer of Memory
Pharmaceuticals. "R4996/MEM 63908 was well tolerated in all four
studies and possesses a favorable pharmacokinetic profile." Phase 1
Trial Results The Phase 1 program for R4996/MEM 63908 included four
studies: a randomized, double-blind, placebo-controlled single
ascending dose study; a food interaction study; a randomized,
placebo-controlled single dose study; and a randomized,
placebo-controlled multiple ascending dose (MAD) study. Overall,
the program included 130 volunteers, of which 66 received single
doses of MEM 63908, 35 received multiple doses of MEM 63908 and 29
received placebo. R4996/MEM 63908 was generally safe and well
tolerated. There were no serious adverse events reported in any of
the trials and only one elderly subject in the program was
discontinued due to an adverse event. This discontinuation was
determined to be a possible study drug related adverse event of
cardiac arrhythmia in a subject in the MAD study. The most commonly
reported adverse event in the trials was somnolence. The plasma
levels achieved in these Phase 1 human studies are well above those
considered necessary to achieve cognitive benefits based on animal
experiments. Pharmacokinetic assessments revealed linear increases
in exposure proportional to dose. About R4996/MEM 63908 R4996/MEM
63908 is a partial agonist of the nicotinic alpha-7 receptor.
Compounds acting on this receptor may have utility in improving
cognitive function in disorders such as Alzheimer's disease or
schizophrenia. The compound is the second clinical candidate being
developed under Memory's nicotinic alpha-7 receptor agonist
collaboration agreement. Under the terms of the agreement, Memory
Pharmaceuticals is responsible for conducting Phase 1 clinical
trials of the compound and Roche is responsible for later stage
development and commercialization. Memory Pharmaceuticals is
entitled to receive milestone payments upon the achievement of
specified development, regulatory, commercialization, and sales
level events for R4996/MEM 63908. 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, for Memory
Pharmaceuticals Corp. Web Site: http://www.memorypharma.com/
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