Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) has signed a deal with CCRM, a Toronto-based pioneer in commercializing and developing regenerative medicine technologies, and gene and cell therapies, to advance the market approval request for NurOwn®. For now, CCRM is helping company explore the opportunity to use Health Canada’s initial access pathway for cure of patients with ALS. If NurOwn® qualifies for the applicable guideline, it could be allowed in Canada for distribution in 2018.
Chaim Lebovits, the CEO and President of Brainstorm, reported that they are delighted to associate with CCRM as they continue their measures to advance and make NurOwn accessible commercially to people suffering with ALS in the coming period. They expect talking with Health Canada staff the report of their ALS clinical plan to date, which they consider demonstrates compelling evidence of efficacy and safety and may qualify for fast review under Canada’s official guidelines for drugs to cure grave or life-threatening conditions.
Dr. Michael May, the CEO and President of CCRM, said that regulatory affairs remains a vital part of the commercialization course which is why they have advanced in-house expertise to provide consulting to their industry and academic partners. Patrick Bedford is working with company to support its measures to bring a cure for ALS to people in Canada.
Bedford added that Health Canada is a leading world-class controller that can use special regulatory course to review preliminary efficacy data and safety data to authorize promising treatments, while awaiting the closure of confirmatory efficacy trials.
In fact, the grave problem of ALS has been particularly identified by Health Canada as a major condition with must require solutions that may even qualify for a regulatory pathway. If BrainStorm’s current clinical trial report is found sufficient, NurOwn could be supplied to Canadians by next year. This is a promising news for the firm.