FDA grants BrainStorm's NurOwn orphan drug designation for treatment of ALS

BrainStorm Cell Therapeutics, Inc.Feb 14 2011

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's NurOwn™ autologous adult stem cell product candidate for the treatment of amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease.

"We are extremely pleased to have been granted the benefits of orphan drug designation as we continue to advance NurOwn™ as a potential new treatment for ALS, for which we expect to begin human clinical trials during the first half of 2011," said Chaim Lebovits, President of BrainStorm. "Because of the safety profile with autologous adult stem cells, potential for intramuscular or intrathecal administration, and multiple mechanisms of action, we feel this product candidate could help effectively address the needs of patients with ALS and other neurological disorders."