BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) has appointed Peter J. Pitts, a former FDA Associate Commissioner and co-founder of the Center for Medicine in the Public Interest, as Executive Chairman and Chief Strategic Regulatory and Policy Officer.

In the role, Pitts will oversee daily strategic operations, corporate partnerships, investor engagements, and clinical-regulatory pathways, according to a company statement. His primary focus will be advancing the Phase 3b trial for the company's NurOwn therapy for amyotrophic lateral sclerosis (ALS) under an FDA Special Protocol Assessment (SPA) agreement, which the company describes as the first SPA granted for an ALS therapeutic candidate.

Professor Jacob Frenkel, who has served as Board Chairman since 2020 and joined BrainStorm's advisory board in 2007, will transition to a Senior Advisor role. The company said Frenkel initiated the succession plan as BrainStorm moves into its late-stage clinical execution phase.

"Securing a leader of Peter's global caliber and deep FDA experience to manage our daily operations transforms our strategic position," said Chaim Lebovits, President and CEO of BrainStorm.

"BrainStorm is advancing a validated, significantly de-risked clinical asset with a clear regulatory blueprint," Pitts said in the statement.

NurOwn has received Orphan Drug designation from both the FDA and the European Medicines Agency. A Phase 3 trial in ALS has been completed, and the Phase 3b trial is set to launch under the SPA agreement.