BrainStorm Cell Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for NurOwn, the company’s autologous adult stem cell product candidate for the treatment of amyotrophic lateral sclerosis.
The company is planning to conduct clinical trials of NurOwn in the first half of 2011.
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BrainStorm president Chaim Lebovits said the company is extremely pleased to have been granted the benefits of orphan drug designation as it continues to advance NurOwn as a potential new treatment for amyotrophic lateral sclerosis.
“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 effectively address the needs of patients with amyotrophic lateral sclerosis and other neurological disorders,” Lebovits added.
The FDA grants orphan drug designation to drugs that treat rare medical conditions affecting fewer than 200,000 individuals in the US.
Amyotrophic lateral sclerosis, also known as Lou Gehrig’s Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Approximately 5,600 people in the US are diagnosed with the disease each year.
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