US FDA grants Fast Track status to BrainStorm Cell Therapeutics for ALS treatment NurOwn

7 October 2014

The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm Cell Therapeutics (Nasdaq: BCLI) 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 II clinical trial in ALS patients.

Tony Fiorino, chief executive of BrainStorm, said: “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. 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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