TEL AVIV Dec 19 Israel's BrainStorm Cell
Therapeutics said it is proceeding to a Phase 3
clinical trial for its adult stem cell treatment in patients
with amyotrophic lateral sclerosis (ALS).
This follows a "successful end-of-Phase 2 meeting" with the
U.S. Food and Drug Administration regarding the treatment it is
developing, called NurOwn, the company said on Monday.
The advanced clinical trial, to be conducted at multiple
sites in the United States and in Israel, is expected to begin
enrolling patients in the second quarter of 2017.
"Building off NurOwn's safety and clinical efficacy observed
to date, we are developing a Phase 3 programme that, if
successful, will position us to bring to the market an
innovative, disease modifying treatment for patients suffering
from ALS," said BrainStorm Chief Executive Chaim Lebovits.
BrainStorm plans to submit an application in Israel that
will allow patient access to NurOwn as a treatment that has been
granted Hospital Exemption. This recently approved pathway would
permit BrainStorm to partner with a medical centre in
Israel and be allowed to treat patients with NurOwn for a fee.
This pathway usually involves a custom-made product, such as
NurOwn, which is made using a patient's own cells.
"We foresee possible treatments under this pathway as early
as the second half of 2017," Lebovits said.
According to the ALS Association, 5,600 people in the United
States are diagnosed each year with the neurodegenerative
disease, also known as Lou Gehrig's Disease, which has severely
disabled British physicist Stephen Hawking.
(Reporting by Tova Cohen)