Stacy Lindborg, PhD, on the Upcoming FDA Advisory Committee Meeting for NurOwn in ALS

The co-CEO of BrainStorm Cell Therapeutics spoke on the supporting data for the investigational ALS cell therapy that will be discussed at the meeting, and expectations for it.

“We are encouraged by the regulatory flexibility the FDA is showing in ALS... FDA flexibility is good for patients in these fatal illnesses and these rapidly progressing illnesses, such as ALS. It's good for science, as it allows us to learn more rapidly as a community in ALS drug development. We are confident in the effectiveness of NurOwn and we're grateful to the FDA for the opportunity to review the full body of clinical evidence.”

BrainStorm Cell Therapeutics has announced an upcoming Advisory Committee Meeting with the FDA to discuss its biologics license application for NurOwn, an autologous bone marrow-derived mesenchymal stem cell therapy which was evaluated for the treatment of amyotrophic lateral sclerosis (ALS) in a phase 3 clinical trial (NCT03280056). Of particular importance for this meeting is the floor effect: the ALS Functional Rating Scale cannot measure disease progression after a certain point in patients with advanced ALS.

In an interview with CGTLive™, Stacy Lindborg, PhD, the co-CEO of BrainStorm Cell Therapeutics, spoke about the upcoming meeting and gave an overview of the relevant clinical trial data, including data which were recently presented at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, held in Dallas, Texas, March 19-22, 2023. The data showed a treatment effect favoring NurOwn over the placebo in a prespecified group of patients who had less-advanced ALS at baseline. Lindborg also discussed positive biomarker data from the trial and the importance of regulatory flexibility for drug development in the ALS space.

1. Brainstorm Cell Therapeutics announces FDA advisory committee meeting to review biologics license application for NurOwn® for the treatment of ALS. News release. BrainStorm Cell Therapeutics Inc. March 27, 2023. Accessed March 27, 2023. 
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