demnächst auf der Basis von Glutamat:
Gedächtnispille soll mentale Fähigkeiten verbessern
Ampakine auch für Behandlung von Alzheimer denkbar
IRVINE, Calif., Jun 21, 2005 (BUSINESS WIRE) -- Cortex Pharmaceuticals, Inc.
(AMEX: COR) announced that the Defense Advanced Research Projects Agency (DARPA)
of the U.S. Department of Defense is sponsoring a new CX717 study. Results from
this study could help confirm and extend the positive findings with CX717 from
the recently completed sleep deprivation study.
Rationale for the Study: The new study will evaluate the cognitive performance
and objective alerting effects of CX717 utilizing a simulated night shift work
paradigm. Volunteers will undergo four nights of simulated shift work during
which they will be "on shift" (high work load) from 11:00 P.M. to 7:00 A.M. The
volunteers will also be restricted to only four hours of recovery sleep on each
of the four study days. Three different doses of CX717 will be compared to
placebo in randomized, double-blind, parallel-group design. The study medication
will be given daily prior to the simulated night shift activities. Outcome
measures will include the maintenance of wakefulness test, cognitive performance
tests, and polysomnography during the recovery sleep period.
According to Dr. Roger G. Stoll, Chairman, President and CEO of Cortex, "Cortex
will supply CX717 and matching placebos for the study. DARPA will fund a
military research organization to conduct the study. The first volunteers are
expected to be enrolled this summer and we expect that the study should be
concluded near the end of the year. Positive results from this study could move
CX717 closer toward a marketable indication, namely to improve wakefulness in
patients with Excessive Daytime Sleepiness (EDS), while at the same time provide
the military with a simulated situation that more closely approximates the
adverse sleep conditions often faced by soldiers during military operations."
Cortex announced on May 3, 2005 that CX717, when compared to placebo, increased
wakefulness in a dose-related manner and improved performance in healthy male
subjects that became impaired during 27 hours without sleep. The study was
performed in the United Kingdom at the Academic Clinic for Disorders of Sleep
and Wakefulness within the Human Psychopharmacology Research Unit at the Medical
Research Centre, School of Biomedical and Molecular Sciences, University of
Surrey by Dr. Julia Boyle, Acting Director of the Research Unit and Professor
Anthony N. Nicholson, Medical Director and Visiting Professor of Aviation
Medicine, King's College London.
About Excessive Daytime Sleepiness (EDS) and Shift Work
There are direct benefits to the broader civilian population from this
AMPAKINE(R) study in EDS. The National Commission on Sleep Disorders estimates
that 40 million Americans are either chronically or intermittently affected with
various sleep disorders. In addition to the tremendous personal pain and
suffering they inflict, sleep disorders are a tremendous drain on the
productivity and safety of our country: falling asleep at the wheel is one of
the most costly and devastating problems on American highways; accidents in the
workplace due to sleep deprivation are commonplace and damaging to industry; the
annual direct cost to society is over $15 billion. AMPAKINE products may also be
useful in the treatment of narcolepsy, jet lag and rotating shift workers in the
workplace.
About DARPA
DARPA is the central research and development organization for the U.S.
Department of Defense. Its primary responsibility is to help maintain
technological superiority for the U.S. military and to guard against unforeseen
technological advances by potential adversaries. The Agency was founded in 1958,
and, over the years, has been responsible for advances in computer networking
(DARPA created the ARPANET, the predecessor to today's Internet), advanced
materials, ballistic missile defense, space launch vehicles, information
processing, advanced computer displays, and many other areas.
About Cortex Pharmaceuticals
Cortex, located in Irvine, California, is a neuroscience company focused on
novel drug therapies for neurological and psychiatric disorders. The Company is
pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds,
which act to increase the strength of signals at connections between brain
cells. The loss of these connections is thought to be responsible for memory and
behavior problems in Alzheimer's disease. Many psychiatric diseases, including
schizophrenia, occur as a result of imbalances in the brain's neurotransmitter
system. These imbalances may be improved by using the AMPAKINE technology.
Cortex has alliances with N.V. Organon for the treatment of schizophrenia and
depression and with Les Laboratoires Servier for the development of AMPAKINE
compounds to treat the neurodegenerative effects associated with aging and
disease, including Mild Cognitive Impairment, Alzheimer's disease and anxiety
disorders. (www.cortexpharm.com/)
Forward-Looking Statement
Note - This press release contains forward-looking statements concerning the
Company's research and development activities. The success of such activities
depends on a number of factors, including the risks that the Company's proposed
compounds may at any time be found to be unsafe or ineffective for the
indications under clinical test and that clinical studies may at any point be
suspended or take substantially longer than anticipated to complete. As
discussed in the Company's Securities and Exchange Commission filings, the
Company's proposed products will require additional research, lengthy and costly
clinical testing and regulatory approval. AMPAKINE compounds are investigational
drugs and have not been approved for the treatment of any disease.
SOURCE: Cortex Pharmaceuticals, Inc.
CONTACT: Cortex Pharmaceuticals, Inc.
Roger G. Stoll, Ph.D., 949-727-3157
or
The Investor Relations Group
Damian McIntosh or Dian Griesel, Ph.D., 212-825-3210
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