4-Ap is a "potassium channel blocker" whose effect is to increase the ability
of damaged axons to conduct impulses. In people with nervous system injury,
such as SCI, the surviving axons frequently lose part of their myelin
sheath--the insulation around the axon that permits it to conduct impulses
without "short circuiting." When the myelin sheath is damaged, the axon can
no longer conduct past the site of the injury and the nerve does not function.
4-AP appears to restore the ability of such nerves to conduct.
In previous human studies totaling about 100 volunteer subjects with chronic
SCI, about a third were reported to show some clinical benefit. Depending on
the individual, these benefits included reduction of central pain and/or
spasticity, restoration of sensory function, increase in muscle strength and
stamina, and in some cases, apparent restoration of bowel, bladder and sexual
control. Most of those benefiting had incomplete (versus complete) lesions.
Acorda currently is sponsoring a Phase II trials of 4-AP at six SCI clinical
rehab centers: Thomas Jefferson Medical Cneter in Philadelphia, Kessler in
New Jersey, Mt. Sinai in NY, MCV in Richmond, VA, Spain Rehab Center in
Birmingham, AL, and Rehab Institute of Chicago. These trials are using a
sustained-release, oral formulation of 4-AP that has been formulated and
rigorously tested by Elan Corporation. We expect the Phase II trial to enroll
a total of 60 volunteer subjects with chronic, incomplete SCI, and to be
completed by the middle of '98. If this trial has promising results, we
hope to initiate a pivotal Phase III trial in the second half of '98.
Volunteer subjects for the trials are be selected by each center acording to
the inclusion criteria specified in the trial design.
Please be aware that there is no charge whatsoever to subjects participating
in the Acorda-sponsored trials. We have been told by several sources that
another group is sponsoring a trial of a different formulation of 4-AP, and is
charging several thousand dollars to be in the trial. This group has no
connection to Acorda. Also, please be aware that 4-AP has potential side
effects, including epileptic-type seizures, and must be administered by
experts in rigorously designed protocols. Our goal is to perform the most
best trials possible to learn whether 4-AP can become a useful, approved
therapy for SCI, and if so, to establish the optimal, safe dosing schedules
for the drug.
Meanwhile, if you would like more information about Acorda and its therapy
development programs for SCI, please send us your address to the email address
below and we will be glad to send you an information kit.
Ron
Ron Cohen, M.D.
Acorda Therapeutics, Inc.
145 W. 58th St., #8J
New York, NY 10019
212 376-7552 (o)
212 765-8637 (fax)
E-mail: acordainc(AT)aol.com