BrainStorm gets FDA fast-track status for ALS stem cell therapy
Israel’s BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration has designated its adult stem cell treatment as a “fast-track” product for the treatment of amyotrophic lateral sclerosis (ALS).
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.
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)