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BrainStorm Cell Therapeutics, Inc. has been granted orphan drug designation for its NurOwn autologous adult stem cell candidate for the treatment of amyotrophic lateral sclerosis (ALS), 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.”

Orphan Drug designation is granted for new drug therapies that treat diseases affecting fewer than 200,000 people in the U.S. and entitles BrainStorm to seven years of marketing exclusivity for NurOwn upon regulatory approval, as well as the opportunity to apply for funding from the U.S. government.