Brainstorm Cell Therapeutics (NSDQ:BCLI) is reportedly seeking early regulatory approval in Canada for its NurOwn stem cell treatment for patients with ALS.
The company told Reuters this week that it has inked an agreement with a Canadian non-profit organization, CCRM, that helps to support the development of regenerative medicine. The organization plans to help BrainStorm meet Canadian regulatory requirements for the early access pathway, which would speed up the treatment’s review process.
If NurOwn qualifies for the rapid review pathway, it could be authorized for distribution in Canada by the beginning of next year, BrainStorm told the news outlet.
“We seemingly fit the criteria,” CEO Chaim Lebovits said.
In December last year, the Israel-based company said it’s preparing for a phase III trial of its stem cell treatment at multiple sites across the U.S. and in Israel. The trial is slated to enroll patients in the 2nd quarter of this year.
BrainStorm is also looking to submit a “Hospital Exemption” application in Israel to allow patient access to NurOwn at a particular medical center. The recently approved pathway would enable BrainStorm to treat patients with its stem cell therapy for a fee.
Lebovits told Reuters that the company could be providing treatments under this pathway as early as the 2nd half of this year.
