BrainStorm seeks Canadian okay for stem-cell treatment

Israel’s BrainStorm Cell Therapeutics is seeking early approval in Canada for its adult stemcell treatment for patients with amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, even before it completes late-stage clinical trials.

BrainStorm said on Tuesday that it had signed an agreement with CCRM, a Canadian nonprofit 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.