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BrainStorm Cell Therapeutics Announces Key FDA Meeting for ALS Treatment

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BrainStorm Cell Therapeutics Inc., a prominent developer of adult stem cell therapies for neurodegenerative diseases, has announced a significant development in their pursuit of treating amyotrophic lateral sclerosis (ALS). The company has secured an in-person meeting with the U.S. Food & Drug Administration (FDA), scheduled for December 6, 2023. This meeting is a critical step in discussing the regulatory pathway for NurOwn®, their leading therapeutic candidate for ALS.

Special Protocol Assessment (SPA) for Phase 3 Trial BrainStorm aims to seek a Special Protocol Assessment (SPA) during this meeting. The SPA is a process in which the FDA and a trial sponsor agree on the design and size of clinical trials. For BrainStorm, this means aligning on the protocol for a confirmatory Phase 3 trial of NurOwn® in ALS. Chaim Lebovits, President and CEO of BrainStorm, expressed optimism about aligning with the FDA on the requirements for re-submitting a Biologics License Application.

About NurOwn® NurOwn® utilizes a novel technology platform involving autologous MSC-NTF cells. These cells are harvested from individuals with ALS and are processed to secrete neurotrophic factors, targeting specific neurodegenerative diseases. The approach has shown promise in addressing disease pathways critical in neurodegenerative disorders. BrainStorm’s commitment to ALS is evident in their extensive preclinical research and clinical studies, all of which have been published in peer-reviewed journals.

Insights from Clinical Trials The NurOwn clinical program has provided valuable insights into ALS pathology, disease progression, and treatment. This includes the analysis of genetic data, which is among the first ALS trials to prospectively use pharmacogenomic analysis of clinical outcomes. Such insights are vital for the development of future treatments for ALS.

BrainStorm’s Broader Mission BrainStorm Cell Therapeutics Inc. is not only focused on ALS but is also a leader in developing innovative autologous adult stem cell therapies for various debilitating neurodegenerative diseases. The company holds exclusive rights for the clinical development and commercialization of the NurOwn® technology platform.

Forward-Looking Statements The press release also contains forward-looking statements regarding the clinical development of NurOwn as a therapy for ALS, its future availability to patients, and the overall success of BrainStorm. These statements are based on current expectations and involve substantial risks and uncertainties.

Conclusion The upcoming FDA meeting marks a pivotal moment for BrainStorm Cell Therapeutics in their journey to bring NurOwn® to the ALS community. The potential agreement on a Phase 3 trial protocol through SPA could significantly de-risk the program and pave the way for a new treatment option for those suffering from ALS.

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