BrainStorm Appoints Former FDA Associate Commissioner Peter Pitts as Executive Chairman to Lead NurOwn Phase 3b ALS Strategy
Key Insights
BrainStorm Cell Therapeutics has named former FDA Associate Commissioner Peter J. Pitts as Executive Chairman and Chief Strategic Regulatory and Policy Officer to drive the upcoming Phase 3b trial for NurOwn.
NurOwn is advancing under the first FDA Special Protocol Assessment (SPA) ever granted for an amyotrophic lateral sclerosis (search) (ALS) therapeutic candidate, providing a clear regulatory blueprint.
Longtime Board Chairman Professor Jacob Frenkel will transition to Senior Advisor after nearly two decades of leadership, marking a strategic succession aligned with the company's late-stage clinical execution phase.
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) has appointed former FDA Associate Commissioner Peter J. Pitts as Executive Chairman and Chief Strategic Regulatory and Policy Officer, marking a significant expansion of its executive leadership as the company prepares to launch a pivotal Phase 3b clinical trial for its investigational ALS therapy, NurOwn.
Pitts, who co-founded the Center for Medicine in the Public Interest, will assume immediate leadership over BrainStorm's daily strategic operations, corporate partnerships, investor engagements, and clinical-regulatory pathways. His primary mandate is to drive the upcoming Phase 3b trial under an active FDA Special Protocol Assessment (SPA) agreement — the first SPA ever granted for an ALS therapeutic candidate.
"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. "As we enter high-stakes corporate partnership and institutional investor discussions, having a former senior FDA official directly overseeing our regulatory and financial strategy dramatically enhances our operational capabilities."
A Strategic Leadership Transition
The appointment coincides with the transition of longtime Board Chairman Professor Jacob Frenkel, who has anchored BrainStorm's leadership since joining its advisory board in 2007 and serving as Chairman since 2020. Frenkel will step down from the chairman role and transition into the position of Senior Advisor, continuing to support the company in an advisory capacity.
"Having steered BrainStorm for two decades since its early advisory days to the launch preparation of this important late-stage trial, I am pleased to pass the torch of board leadership to Mr. Pitts," Frenkel said. "His willingness to step into an active executive role provides the ideal catalyst for my transition, and I look forward to supporting Mr. Lebovits and Mr. Pitts in this next exciting chapter for the company."
Lebovits acknowledged Frenkel's contributions, stating: "On behalf of the entire Board of Directors, I want to express our deepest gratitude to Professor Frenkel for his vision, dedication, and steadfast leadership over these many years. His guidance has been instrumental in bringing BrainStorm to this pivotal moment."
NurOwn and the Regulatory Pathway
NurOwn is an investigational autologous stem cell therapy designed to treat neurodegenerative diseases. The therapy uses a patient's own mesenchymal stem cells (search) to produce neurotrophic factor-secreting cells intended to reduce neuroinflammation and promote neuroprotection. The candidate has received orphan drug designation from both the FDA and the European Medicines Agency for ALS.
Following completion of a Phase 3 clinical trial, BrainStorm is now preparing to initiate a Phase 3b study under its FDA Special Protocol Assessment agreement. The SPA represents a regulatory framework intended to align clinical trial design with agency expectations for potential marketing approval.
"BrainStorm is advancing a validated, significantly de-risked clinical asset with a clear regulatory blueprint," Pitts said. "I am coming 'all in' because the science behind NurOwn is compelling and the patient need in ALS is urgent."
The leadership appointment positions BrainStorm to focus on executing the Phase 3b trial while advancing regulatory, partnership, and financing initiatives in support of its long-term commercialization strategy. Companies approaching pivotal clinical trials often expand leadership teams with executives experienced in regulatory strategy, capital markets, and commercialization to support potential product approvals and strategic transactions.