Cortex Pharmaceuticals plans to begin early next year a clinical trial
of its Ampalex compound in patients suffering Alzheimer's disease, Chief
Financial Officer Scott Hagen told Reuters.
But beyond the initial Phase 1/2 study, which is expected to last four
to six months, it will need to team with a larger pharmaceutical company
to help it fund further development.
Cortex, which has already demonstrated Ampalex improves memory in healthy
patients, is already in talks with a number of drug companies, Hagen said.
He added, however, that a merger was less likely than a strategic alliance.
"The fact that we've seen (improved memory) in healthy young people
and healthy elderly people and in a wide range of animals suggests we're
on the right track," Hagen said.
Assuming tests continue to show the compound's safety and effectiveness,
he projected Cortex could have a drug for Alzheimer's disease on the market
in four to five years.
As in the forgetfullness that occurs in the normal process of aging, memory
loss in Alzheimer's patients is caused by a deficit in brain neurotransmitter
activity. The difference with the Alzheimer's population is that the deficit
is so severe it overwhelms the body's own compensating mechanisms.
Hagen stressed that the company does not see Ampalex as a cure for Alzheimer's.
"What it is likely to do, if it is effective, is set the clock back
by six months or a year and provide the patient with a longer window of
normal functions," he said.
Within the next six months Cortex plans to begin clinical studies of Ampalex
on schizophrenics.
While drugs already exist to control the hallucinations, delusions and
emotional withdrawal associated with schizophrenia, other symptoms or "cognitive
dysfunctions" have not been adequately addressed, Hagen said.
Those cognitive symptoms include disordered thinking that often prevent
schizophrenics from returning to a normal life.
"The thinking is that schizophrenia also involves a problem with the
glutamate," which is the prominent neurotransmitter in the human brain,
Hagen said.
"We've had a great deal of interest from clinicians working in the
schizophrenia field," he said.
Cortex is one of a host of companies working on a drug to treat stroke
victims. It is conducting preclinical research of inhibitors of the enzyme,
Caplain, which appears to be responsible for most of the brain damage that
follows a stroke.