BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) appointed Peter J. Pitts to its board of directors, effective immediately, the company announced.

Pitts previously served as associate commissioner at the U.S. Food and Drug Administration and as a member of the U.S. Senior Executive Service. He currently serves as president and co-founder of the Center for Medicine in the Public Interest.

The appointment comes as BrainStorm prepares to initiate its Phase 3b trial evaluating NurOwn for amyotrophic lateral sclerosis (ALS) under an FDA Special Protocol Assessment. The company stated this represents the first Special Protocol Assessment granted for an ALS therapeutic candidate.

"BrainStorm is conducting some of the most important and scientifically rigorous work in neurodegenerative medicine today," Pitts said in a statement. "The FDA's Special Protocol Assessment for this Phase 3b trial is unprecedented in ALS and sends a powerful signal that the agency recognizes both the seriousness of the disease and the strength of the trial design."

Chaim Lebovits, president and chief executive officer of BrainStorm, said the company was "honored to welcome Peter Pitts to the BrainStorm Board at this defining moment for our Company and for the ALS community."

BrainStorm develops autologous stem cell therapies for neurodegenerative diseases. The company's NurOwn platform uses autologous mesenchymal stem cells to produce neurotrophic factor-secreting cells designed to modulate neuroinflammation and promote neuroprotection.

NurOwn has received Orphan Drug designation from both the FDA and the European Medicines Agency for ALS treatment. The company completed a Phase 3 trial in ALS and plans to launch the Phase 3b trial under the Special Protocol Assessment agreement with the FDA.