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Brainstorm’s Stem Cell Based Drug NurOwn Gets FDA Fast Track Approval


BrainStorm Cell Therapeutics, an Israeli developer of adult stem cell technologies for neurodegenerative diseases, announced that the US Food and Drug Administration has designated NurOwn as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease).

Based in Petah Tikva with offices in New York, BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases.

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Research involving stem cells has been controversial because such cells are sometimes acquired from aborted fetuses. But since such cells contain the basic genetic codes without having yet been specialized as cells for a specific organ, scientists say that they are invaluable for developing cures to a plethora of diseases.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and demonstrate the potential to address unmet medical needs. Under the FDA Modernization Act of 1997, the Fast Track program provides for increased meetings with and written communications from the FDA, and allows for the submission of an NDA on a rolling basis.

NurOwn has been administered to over 30 patients with ALS in clinical trials conducted in Israel, and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States.

It 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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