BrainStorm : FDA Grants Fast Track Designation To NurOwn For Treatment Of ALS

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI), a developer of adult stem cell technologies for neurodegenerative diseases, said that the United States Food and Drug Administration or FDA has designated NurOwn as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease).

NurOwn consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors, and is currently being studied in a randomized, double-blind, placebo-controlled phase 2 clinical trial in ALS patients.

"We are pleased that the FDA has granted Fast Track status for NurOwn as this will allow us greater and more frequent dialogue with the Agency as we continue the development of this ground-breaking cell therapy for the treatment of ALS," said Tony Fiorino, Chief Executive Officer of BrainStorm.