BrainStorm seeks early
approval for stem cell treatment in Canada
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[February 21, 2017]
TEL AVIV (Reuters) - Israel's
BrainStorm Cell Therapeutics is seeking early approval in Canada for its
adult stem cell treatment for patients with amyotrophic lateral
sclerosis (ALS), a neuro-degenerative disease, even before it completes
late-stage clinical trials.
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BrainStorm said on Tuesday that it had signed an agreement with CCRM,
a Canadian not-for-profit organization that supports development of
regenerative medicine, to support a market authorization request for
its ALS treatment, called NurOwn.
CCRM is helping BrainStorm meet requirements for the Canadian health
regulator's early access pathway, which provides rapid review for
drugs to treat serious or life-threatening conditions.
If NurOwn qualifies, it could be authorized in Canada for
distribution by the start of 2018, the company said.
"We seemingly fit the criteria," BrainStorm Chief Executive Chaim
Lebovits told Reuters.
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At the same time, BrainStorm will conduct a Phase 3 clinical trial
for NurOwn at multiple sites in the United States and Israel. The
company in December said the advanced clinical trial is expected to
begin enrolling patients in the second quarter of 2017.
BrainStorm also 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 center in Israel and be allowed
to treat patients with NurOwn for a fee.
Lebovits foresees possible treatments under this pathway as early as
the second half of 2017.
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BrainStorm is also examining whether it may be eligible for early
approval in the United States under new legislation passed in
December that supporters say will speed access to new drugs.
According to the ALS Association, 5,600 people in the United States
are diagnosed each year with the disease, also known as Lou Gehrig's
Disease, which has severely disabled British physicist Stephen
Hawking.
(Reporting by Tova Cohen; Editing by Mark Potter)
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