BioTuesdays

BrainStorm completes enrollment of Phase 3 ALS trial

BrainStorm Cell Therapeutics (NASDAQ:BCLI) completed enrollment of its 200-patient Phase 3 trial evaluating NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).

The NurOwn process involves isolating mesenchymal stromal cells (MSCs) from a patient’s bone marrow and converting them into neurotropic factor secreting cells, or MSC-NTFs. NTFs are growth factors known to support the survival of neurons.

The trial, which has been enrolling patients since October 2017, is being conducted at six sites in the U.S. The primary outcome measure for the study will use a responder analysis score. 

“To date, a significant percentage of the 200 enrolled patients have received three treatments and we expect that all trial participants will complete planned study visits and assessments by October 2020,” president and CEO Chaim Lebovits said in a statement.

BrainStorm expects to report topline results of the trial by then end of 2020.

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