#United States #Boston #BrainStorm #ALS #NurOwn

Unlocking the Future of ALS Research

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a prominent player in the development of innovative cellular therapies for neurodegenerative conditions, is gearing up for a significant presentation at the 4th Annual ALS Drug Development Summit scheduled for May 12-14, 2025, in Boston, MA. This year's summit is expected to be pivotal, providing BrainStorm with the platform to share pioneering insights from its ongoing research development initiatives, particularly concerning their investigational therapy, NurOwn®.

Presenting New Biomarker Insights

At this key event, Dr. Netta Blondheim-Shraga, Senior VP of Research and Development for BrainStorm, will unveil critical findings related to cerebrospinal fluid (CSF) biomarker pathways that are linked with NurOwn. This investigational therapy aims to significantly influence the treatment landscape of amyotrophic lateral sclerosis (ALS). Dr. Blondheim-Shraga's presentation will detail how these biomarkers relate to clinical outcomes and the variability of the disease, contributing invaluable data to the understanding of ALS and its progression.

"Our biomarker data from the earlier Phase 3 study indicates a possible multimodal mechanism of action, which enhances our insight into NurOwn’s potential impact on ALS disease pathways," stated Blondheim-Shraga. This data is instrumental as it shapes the forthcoming Phase 3b trial, which benefits from a Special Protocol Assessment (SPA) agreement with the FDA, further affirming the methodical rigor of BrainStorm's research approach.

Redefining Clinical Trial Paradigms

In addition to presenting biomarker insights, Dr. Bob Dagher, Executive VP and Chief Medical Officer at BrainStorm, will lead discussions on innovative clinical trial designs that incorporate adaptive and decentralized methodologies. These modern approaches aim to bolster enrollment, widen geographic participation, and lessen the burden on individuals coping with ALS. Dr. Dagher emphasized the pressing need to innovate ALS trial protocols to not only meet scientific standards but also to align with real-world feasibility, ensuring a smoother operational framework for researchers and participants alike.

Mary Kay Turner, Senior VP of Global Patient Advocacy and Public Affairs, will spearhead a panel focusing on the accessibility of investigational therapies through expanded access programs. This engaging discussion will tackle how patients' diagnostic journeys impact their decisions regarding trial participation and highlight the significance of early patient engagement in shaping research protocols. The panel aims to identify strategies that increase accessibility and foster trust among those involved in clinical trials.

Implications of BrainStorm’s Research

BrainStorm's active involvement in the ALS Drug Development Summit signifies a crucial moment in its development trajectory. As the company prepares to launch its Phase 3b clinical trial for NurOwn under the FDA’s SPA, it is also essential to acknowledge the broader implications of their research. The advancements in understanding ALS pathology will not only contribute to the efficacy and development of NurOwn but could also pave the way for further innovations in ALS treatment methodologies. This has the potential to transform the clinical landscape for neurodegenerative diseases, benefitting countless patients and their families.

Conclusion

BrainStorm Cell Therapeutics is at the forefront of ALS research, leveraging its findings to influence both clinical applications and patient involvement in trials. As this year's summit approaches, the anticipation for their contributions continues to build within the scientific and medical communities. Unpacking the complexities of ALS through rigorous research and innovative trials could ultimately support the pursuit of effective therapies and improve the lives of individuals battling this devastating disease.

Through collaborative efforts and a commitment to advancing understanding in neurodegenerative research, BrainStorm is poised to make significant strides in ALS treatment and care in the years to come.