Nachrichtenbrett
Nachrichtenbrett
IRVINE, Calif., June 19, 1996 -- (Nasdaq: CORX) today announced the
results of the third in a series of double-blind, placebo-controlled human
studies with AMPALEX (CX516). CORTEX is developing AMPALEX for the potential
treatment of memory deficits in the early stages of Alzheimer's disease. The
drug was found to be safe and well-tolerated by the healthy young volunteers in
this study. Measures of learning and memory performance revealed significant
improvement in the AMPALEX group in comparison to placebo.
In announcing the results, Vincent Simmon, Ph.D., President and Chief
Executive Officer, said "This study confirms that AMPALEX is safe and
well-tolerated on acute oral administration to healthy volunteers, and provides
important additional evidence of positive effects on performance on tasks of
learning and memory. On the basis of these results, we plan to initiate
additional studies in the target patient population, those experiencing deficits
of memory and cognition in the early stages of Alzheimer's disease."
AMPALEX was safe and well-tolerated by all volunteers receiving drug, with
no adverse events reported. All laboratory values and measures of brain and
cardiac function were within normal limits. Significant improvements in
performance on measures of learning and memory were noted in the drug group. On
a picture association task, volunteers receiving AMPALEX had significantly
better delayed recall than those receiving placebo. Enhanced learning and
memory was also suggested by an odor recognition task, with the drug group
demonstrating significantly better recall of difficult odor pairs on drug days
in comparison to placebos.
The study, which involved 24 healthy young volunteers, was conducted at the
Karolinska Hospital in Stockholm under the direction of Dr. Martin Ingvar. The
12-volunteer placebo group received placebo on all study days (1 to 5), while
the 12-volunteer drug group received 300 mg of AMPALEX orally on days 2 and 3
and placebo on days 1, 4 and 5. Evaluations were conducted at the time of
screening for inclusion in the study, immediately prior to study commencement,
on each of five consecutive study days, and at a one-week follow-up appointment.
CORTEX, located in Irvine, California, is a neuroscience company focused on
the development of drugs for the treatment of neurological and psychiatric
disorders. The primary programs at the Company are centered on AMPAKINEs(TM), a
family of orally-available compounds that enhance the functioning of the AMPA
receptor, which is believed to be critical for memory formation and which is
involved in most "excitatory" communication in the human brain.
CORTEX is developing AMPAKINEs for potential use in the treatment of deficits of
memory and cognition due to Alzheimer's disease and in the treatment of
schizophrenia. The Company is also investigating the potential use of calpain
inhibitors in the treatment of stroke and cerebral vasospasm.
Note: This press release contains forward-looking statements. Actual results may differ materially, depending on a number of risk factors, including the risk that AMPAKINEs may at any time be found to be toxic or ineffective for any or all of their proposed indications. As discussed in the Company's Securities and Exchange Commission filings, the Company's products, including AMPAKINEs, will require additional research and development, extensive clinical testing and regulatory approval, which approval is subject to various regulatory requirements and which can be lengthy.
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