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.
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.
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.
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.