BrainStorm Cell Therapeutics Appoints Former FDA Associate Commissioner Peter J. Pitts to Board of Directors

BrainStorm Cell Therapeutics Inc. has announced the appointment of Peter J. Pitts to its Board of Directors. Pitts, a former Associate Commissioner at the U.S. Food and Drug Administration (FDA) and President of the Center for Medicine in the Public Interest (CMPI), joins the company as it prepares to launch a Phase 3b clinical trial for its ALS treatment, NurOwn®, under an FDA Special Protocol Assessment.

Pitts is recognized for his expertise in healthcare policy, regulatory science, and FDA governance. His appointment aligns with BrainStorm's plans to initiate the Phase 3b ENDURANCE trial, which is set to evaluate NurOwn® for amyotrophic lateral sclerosis (ALS) with funding acquisition.

"BrainStorm is conducting some of the most important and scientifically rigorous work in neurodegenerative medicine today," Pitts stated. He emphasized that the FDA's approval of a Special Protocol Assessment for the trial signifies the agency's recognition of the disease's seriousness and the trial's robust design.

Chaim Lebovits, President and Chief Executive Officer of BrainStorm, expressed the company's honor in welcoming Pitts at this crucial time. "Peter's unparalleled regulatory expertise, credibility, and commitment to patients will be invaluable as we initiate the Phase 3b ENDURANCE trial," Lebovits remarked.

Pitts has contributed commentaries on regulatory issues and healthcare reform to major publications and has published peer-reviewed studies in reputable medical journals. BrainStorm develops autologous stem cell therapies for neurodegenerative diseases and has completed prior trials for ALS, receiving Orphan Drug designation from both the FDA and the European Medicines Agency (EMA).