BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the United States Food and Drug Administration (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, MD, PhD, Chief Executive Officer of BrainStorm. "We expect Fast Track designation, which recognizes the potential of NurOwn™ as to address an unmet medical need in ALS, to help speed and improve our development program."
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