TORONTO, ON, HACKENSACK, N.J. & PETACH TIKVAH, ISRAEL, – BrainStorm Cell Therapeutics Inc., a company developing adult stem cell technologies for neurodegenerative diseases, has signed an agreement with CCRM in support of its market authorization request for NurOwn®.
CCRM is a Toronto-based company focused on developing and commercializing regenerative medicine technologies, specifically cell and gene therapies. Through the agreement, CCRM will help Brainstorm explore opportunities to access Health Canada’s early access pathway for treatment of patients with Amyotrophic Lateral Sclerosis (ALS). If NurOwn® qualifies for Health Canada’s “Notice of Compliance with Conditions” pathway, it could be authorized in Canada for distribution in early 2018.
The company will work Patrick Bedford, manager of clinical translation and regulatory affairs at CCRM.
“We are pleased to partner with CCRM as we continue our efforts to develop and make NurOwn available commercially to patients with ALS as quickly as possible,” says Chaim Lebovits, president and CEO of BrainStorm. “We look forward to discussing with Health Canada staff the results of our ALS clinical program to date, which we believe shows compelling evidence of safety and efficacy and may qualify for rapid review under Canada’s regulatory guidelines for drugs to treat serious or life-threatening conditions.”
“Regulatory affairs is an essential part of the commercialization process which is why CCRM has developed in-house expertise to offer consulting to our academic and industry partners,” explains Dr. Michael May, president and CEO, CCRM. “Patrick Bedford is working with BrainStorm to support its efforts to bring a treatment for ALS to patients in Canada.”
Stacey Johnson (@msstaceyerin) , director, communications and marketing at CCRM and editor of Signals Blog discusses the deal this week via her Right Turn column: http://www.signalsblog.ca/right-turn-new-stem-cell-product-for-als-seeking-approval-in-canada/.