The company said it aims to be the first worldwide to win approval to conduct trials using adult stem cells taken from patients.
Biopharmaceutical company BrainStorm Cell Therapeutics Ltd. (Bulletin Board:BCLI.OB) has arranged a first meeting with the US Food and Drug Administration (FDA) to coordinate clinical trials for its flagship product for the treatment of Parkinson's disease. The company said it aims to be the first worldwide to win approval to conduct trials using adult stem cells taken from patients.
BrainStorm has hired Dr. Andra E. Miller, director of cell and gene therapies of the Biologics Consulting Group, Inc. as consultant to handle the company’s negotiations with the FDA.
BrainStorm president Chaim Lebovits said, "BrainStorm’s preclinical research related to Parkinson's disease has reached the stage where we are ready to approach the FDA about initiating clinical Phase I trials."
Published by Globes [online], Israel business news - www.globes.co.il - on August 22, 2007
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