NurOwn phase 3 trial : BrainStorm Cell Therapeutics, a US biotech company engaged in developing adult stem cell therapies for neurodegenerative diseases, has completed the dosing of all the participants in a phase 3 trial of NurOwn (MSC-NTF cells) in amyotrophic lateral sclerosis (ALS).
The late-stage trial enrolled nearly 200 participants, who have been randomized equally to be subjected to three doses of MSC-NTF cells or placebo, administered for a duration of four months.
The US biotech company anticipates top-line data from the amyotrophic lateral sclerosis clinical trial to be available in the fourth quarter of this year.
Commenting on the NurOwn phase 3 trial, Chaim Lebovits – CEO of BrainStorm Cell Therapeutics, said: “Completion of participant dosing in this clinical trial is an important milestone and brings us a step closer to potentially filing a Biologics License Application to make MSC-NTF cells available to people with ALS.
“I would like to thank the investigators and their staff at the participating sites for their clinical excellence, especially for enabling this trial to complete on time in the middle of the ongoing COVID-19 pandemic. I must also express my complete gratitude to the trial participants and their loved ones who fully devoted themselves to the challenges of bringing an investigational therapeutic forward.”
The NurOwn phase 3 trial is being carried out at six centers of excellence, namely University of California, Irvine, University of Massachusetts Medical School, California Pacific Medical Center, Cedars-Sinai Medical Center, Massachusetts General Hospital, and Mayo Clinic.