BrainStorm Cell Therapeutics has received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the Phase II clinical trial of NurOwn in progressive multiple sclerosis patients.
The recommendation comes after the review of safety outcomes from a pre-specified interim analysis involving nine study participants. DSMB said that the trial can continue without any changes.
NurOwn, which is made up of mesenchymal stromal stem cells secreting neurotrophic factors (MSC-NTF) cells, is designed to target disease pathways in neurodegenerative disorders.
MSC-NTF cells are generated using autologous, mesenchymal stem cells (MSCs) that have been extracted from bone marrow, expanded and differentiated ex-vivo.
BrainStorm said that autologous MSC-NTF cells can deliver various NTFs and immunomodulatory cytokines directly to the target site and induce a biological effect to slow or stabilise disease progression.
The multi-centre, open-label, multi-dose Phase II trial is assessing the safety and efficacy of repeated intrathecal administration of NurOwn in a total of 20 patients.
The primary outcome of the study is the incidence of treatment-emergent adverse events, while secondary outcome measures include the change in timed 25-foot walking speed or 9-Hole Peg Test from baseline and number of patients with changes in neurotrophic factors.
BrainStorm Cell Therapeutics president and CEO Chaim Lebovits said: “BrainStorm is focused on completing the NurOwn progressive MS Phase II study and to bringing a much-needed treatment option to MS patients.
“The DSMB review confirms the safety profile at this stage of the study of repeat dose intrathecal administration of NurOwn in this patient population.”
In addition to the Phase II progressive multiple sclerosis trial, the company is assessing NurOwn in a randomised, placebo-controlled Phase III trial to treat amyotrophic lateral sclerosis (ALS).