new drug

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Studies Find that Ampakines Are First Drugs to

Specifically Target Affected Portions of the

Brain

08:46 a.m. May 14, 1999 Eastern

IRVINE, Calif., May 14 /PRNewswire/ -- New

studies of

Ampakines®, a class of oral compounds in

clinical trials for

the treatment of schizophrenia and Alzheimer's

disease, indicate

that the drugs act with unprecedented

specificity for areas of

the central nervous system directly related to

behavioral

abnormalities arising from neurological

disturbances, according

to Lynch, Ph.D., Professor of Psychiatry

at the University

of California, Irvine (UCI). Ampakines,

including the lead drug,

Ampalex®, are being developed by Cortex

Pharmaceuticals,

Inc. (OTC Bulletin Board: CORX). Professor

Lynch disclosed

the findings at the 54th Annual Scientific

Convention of the

Society of Biological Psychiatry in

Washington, D.C. Professor

Lynch also presented updated clinical data

from a recently

completed study in schizophrenia patients

conducted by

C. Goff, M.D., Director of the

Psychotic Disorders

Program at Massachusetts General Hospital.

" Pre-clinical results with Ampalex (CX516)

suggest an

unprecedented degree of specificity for a drug

targeting central

nervous system diseases, " said Professor

Lynch. " We have

sought a drug that could be conveniently taken

by mouth, but

which only affects brain activity, not other

sites in the body, and

acts potently at the desired site of action in

the brain. The new

studies by Ursula Hess, Ph.D. and Professor

Gall,

Ph.D. demonstrate an effect of just this kind.

I don't know of a

comparable case for other psychiatric drugs. "

Employing a commonly used model to assess new

drugs to

treat schizophrenia, rats were chemically

treated so that the

substantia nigra on one side of their brain

was destroyed,

thereby eliminating the normal communication

via the

neurotransmitter dopamine on one side of the

brain. Then the

rats were treated with methamphetamine, which

greatly

increases dopamine. Due to the brain lesion,

only one side of

the brain can be activated. The rats react to

these combined

treatments by spinning in a circle because of

the absence of

dopamine input on one side of their brains and

the elevated

level of dopamine on the other side. Treating

the compulsively

spinning rats with an Ampakine reduced the

spinning.

Afterwards, the brains of the animals were

examined to

determine in what areas the Ampakine had been

active.

Ampakines increase nerve cell communications

based on

glutamate. The investigators discovered that

the Ampakines

substantially increased the brain activity of

the motor cortex, on

the side of the brain needed to reduce the

spinning.

" We have a drug that is distributed throughout

the brain, but

increases the activity of the cortex on the

appropriate side of

the brain, " Professor Lynch stated. " That is

the goal we had in

mind when we first invented these compounds.

Ampakines are

activity dependent and, in this case, the rat

is trying to stop the

continuous spinning, but is unable to do so

without an

Ampakine being present. However, when we

administer the

Ampakines, the signals between nerve cells are

enhanced and

the animal can control its spinning behavior. "

These results were developed through research

supported by

Cortex and conducted at UCI by Professor Lynch

and his

colleague, Gall, Ph.D., Professor of

Anatomy and

Neurobiology.

In addition to the research on rats, Professor

Lynch provided

additional information about the results of

the recently

completed clinical trial with Ampalex in 19

patients with

schizophrenia at Massachusetts General

Hospital. In that study

reported at the International Congress on

Schizophrenia

Research, C. Goff, M.D., principal

investigator,

reported that Ampalex was well tolerated and

did not induce

any significant adverse effects, while

appearing to have

improved a number of aspects of attention,

memory and

cognitive function as measured by a battery of

neuropsychiatric

tests. There was a consistent pattern of

improvement in

cognitive measurements, which makes the

results compelling.

Dr. Goff also noted that the improvements seen

in

CX516-treated patients appeared to persist for

a period of

time after the cessation of CX516 treatment.

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 Ampakines,

which act to

increase the strength of signals at

connections between brain

cells. The weakening or loss of these

connections is thought to

be responsible for memory difficulties from

Alzheimer's disease

and to contribute to cognitive dysfunction in

schizophrenia.

In January 1999, Cortex and NV Organon entered

into an

exclusive worldwide license agreement for

Organon to develop

and commercialize Cortex's proprietary

Ampakine technology

for the treatment of schizophrenia and, at

Organon's option, in

the area of depression. Organon, based in Oss,

The

Netherlands, a pharmaceutical business unit of

Akzo Nobel,

employs 10,000 persons worldwide, over 1,500

of who are

involved in R&D. Its pharmaceutical products

are sold in more

than 100 countries.

Note -- This press release contains

forward-looking statements

concerning the Company's research and

development activities

and business development plans. Actual results

may differ

materially, depending on a number of risk

factors, including the

risks that current or future patent

applications will not result in

patents being issued; that competitors may

challenge or design

around the Company's patents or develop

competing

technologies; that the Company's proposed

products may at

any time be found to be toxic or ineffective

for any or all of

their proposed indications; that clinical

studies may be

suspended or take substantially longer than

anticipated to

complete and that the Company may be unable to

arrive at

corporate partnerships with larger

pharmaceutical companies

on acceptable terms and therefore be required

to continue to

fund clinical development of Ampakines through

the sale of

additional equity securities or otherwise. 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.

CX516 is an investigational drug and has not

yet been shown

to have efficacy in the treatment of any

disease.

More information at www.cortexpharm.com

Background of Ampakines

Recent studies have shown that between the

ages of 25 and

55, individuals lose approximately 25% of the

connections

between nerve cells. This loss of synapses,

most commonly

exhibited as a reduction in the ability to

recall recent events,

affects many systems including memory, libido,

senses such as

hearing and taste, and mood. In Alzheimer's

disease, this decay

process is greatly accelerated.

The vast majority of the connections

(synapses) in the brain use

glutamate as the chemical messenger between

nerve cells, and

the loss of the glutamate connections has been

directly linked to

loss of memory and cognitive function. Reduced

activity of

these connections is associated with a number

of neurological

diseases including schizophrenia and may also

have a role in

depression.

Scientists from Cortex and the University of

California, Irvine

(UCI) have invented a revolutionary new family

of drugs called

Ampakines® that enhance or amplify glutamate

communications in the brain. Ampakines amplify

the effect of

glutamate on a particular subset of receptors

called AMPA

receptors. Published studies demonstrate that

Ampakines can

dramatically enhance memory in elderly animals

and humans.

Cortex pioneered the technology of amplifying

glutamate based

nerve communication and for a number of years

had the field to

itself. This provided the window for obtaining

a strong patent

portfolio, as evidenced by its patents on the

use of AMPA

modulation to treat schizophrenia and to

improve memory and

cognitive function.

Cortex's Ampakine family of compounds,

numbering

approximately 300 to date, target nerve cell

connections that

exist only in the brain. Unlike many other

central nervous

system drugs, they do not have any significant

effects outside of

the brain. In clinical trials in healthy

volunteers and in patients

with schizophrenia, CX516, the initial

Ampakine being tested,

appears to increase memory and cognition. The

potential uses

for the Ampakines, based on the results of

clinical studies as

well as studies in animals, include

schizophrenia, Alzheimer's

disease, depression, sexual dysfunction,

attention deficit

hyperactivity disorder, and a number of other

neurological

diseases and disorders. SOURCE Cortex

Pharmaceuticals,

Inc.