|
 BrainStorm's treatment, called NurOwn, is being studied in a
mid-stage clinical trial in patients with ALS, also known as Lou
Gehrig's Disease.
The FDA's fast track program is designed to speed up access to drugs
intended to treat serious conditions and which have the potential to
address unmet medical needs.
"The receipt of fast-track designation from the FDA is an
acknowledgement of the unmet medical need in ALS," BrainStorm Chief
Executive Tony Fiorino said on Tuesday.
"What is so valuable about fast track designation to a small company
like BrainStorm is the opportunity to have increased meetings with
and more frequent written communication from the FDA," he said,
adding that only a small number of cellular therapies have received
FDA approval.
BrainStorm said the last patient has completed the last visit in its
phase 2a clinical trial in ALS at Hadassah Medical Center in
Jerusalem. The company expects to release final results of the study
in the fourth quarter of 2014.
[to top of second column] |
NurOwn is also being studied in a phase 2 clinical trial at three
sites in the United States.
According to the ALS Association, 5,600 people in the United States
are diagnosed each year with the disease, which has severely
disabled British physicist Stephen Hawking.
(Reporting by Tova Cohen, editing by Louise Heavens)
[© 2014 Thomson Reuters. All rights
reserved.] Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
