Benzinga | Nov 29, 2021 07:32AM EST

BrainStorm Cell Therapeutics Announces The Presentation Of New Analyses From The Phase 3 Trial Of NurOwn In ALS At The 4th Annual ALS ONE Research Symposium

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the presentation of new analyses from the Phase 3 trial of NurOwn at the 4th Annual ALS ONE Research Symposium. The presentation, which will be delivered Tomorrow by Dr. Jonathan Katz, a co-principal investigator on the trial and Chair of the Neurology Department and Director of the Forbes Norris ALS Clinic at the California Pacific Medical Center, showed that although the Phase 3 trial did not reach statistical significance on the primary and secondary endpoints, pre-specified and post hoc analyses leveraging different methods of exploring the heterogeneity of baseline disease in the trial, revealed the potential for a meaningful treatment effect across endpoints when focusing on a subset of participants with less severe disease at baseline.

Additional key findings from the presentation included:

* The observed potential treatment effect of NurOwn on ALS disease progression in participants with less severe disease was protected by randomization.

* The Phase 3 trial of NurOwn in ALS included a higher percentage of participants with advanced ALS at baseline (ALSFRS-R ? 25) compared to other trials, resulting in a lower baseline mean.

* In the subgroup of participants that are predicted by the ENCALS model to have long to very long survival, NurOwn treated participants had a greater percentage of responders compared to placebo (33% vs 14%).

* In the pre-specified subgroup of participants with ALSFRS-R greater than or equal to 35 at baseline, NurOwn had a greater percentage of responder compared to placebo (34.6% versus 15.6%).

* Analyses that focus both on baseline ALSFRS-R and ENCALS model categories suggest that efficacy measurements are impacted in participants with more severe disease.

"These compelling analyses add to the positive momentum behind our ALS program, and we were pleased to have the opportunity to share them with the clinical community at this year's ALS ONE Research Symposium," said Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, Brainstorm Cell Therapeutics. "We are very encouraged by the observation that there appears to be a meaningful treatment effect in patients with less severe disease at baseline that is consistent when using baseline ALSFRS-R scores and the ENCALS model which incorporates additional important disease characteristics that have been shown to be predictive of survival time. We believe this is an important finding, especially since this effect was protected by randomization. Looking ahead, we are eager to share additional analyses from our Phase 3 trial with the clinical community through a peer reviewed publication and remain committed to pursuing the best and most expeditious path forward to bring NurOwn to patients with ALS."

The slides from the presentation will be available on the Publications page of Brainstorm's corporate website following the conclusion of the ALS ONE Research Symposium.