BrainStorm Cell Therapeutics Inc., a New York-based developer of adult stem cell therapies for neurodegenerative diseases, announces the acceptance of a clinical abstract documenting an association between MRI measures and functional improvement in patients with progressive multiple sclerosis (MS).
The data, to be presented at the forthcoming MSVirtual2020 meeting—the eighth joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)—will inform analysis of clinical outcomes in the company’s ongoing Phase 2 trial of NurOwn (MSC-NTF cells) in patients with progressive MS.
“Although disability improvement is an important measure of function in individuals with progressive MS, the MRI features that correlate with disability improvement had not previously been explored,” says Tanuja Chitnis, MD, FAAN, professor of neurology at Harvard Medical School, senior neurologist at Brigham and Women’s Hospital, and director of the Comprehensive Longitudinal Investigations in MS at the Brigham (CLIMB study).
“In this analysis, we have demonstrated a correlation between specific brain and spinal cord MRI measures and observed functional improvements in progressive MS patients. We are grateful to the joint ACTRIMS/ECTRIMS abstract committee for allowing us to present these data, which we hope will facilitate analysis of clinical trial outcomes that specifically evaluate functional improvements in progressive MS.”
Chitnis and colleagues evaluated MRI features of 48 participants in the SysteMS substudy of the CLIMB study, a nested cohort selected to match the inclusion criteria of the Phase 2 NurOwn trial in progressive MS (NCT03799718). The participants underwent brain and lesion volumetric analysis, as well as mean upper cervical cord (MUCCA) analysis, 12-24 months following baseline 3 Tesla MRI.
These analyses generated 34 MRI data measures performed by ICOMETRIX, which the investigators compared in patients with improved function versus those with worsening or stable function, as measured by 9-hole peg test (9HPT) or timed-25-foot-walk (T25FW) scores, two well-established measures of function in progressive MS.
Seventeen patients had improved 9HPT scores from baseline to 12-24 months later, compared to 29 with worsened or stable 9HPT scores over that same period. Whole brain volume at baseline (improved 9HPT: 1505±51 vs. stable-worse 9HPT: 1471±62; p=0.069; t-test) and follow-up (improved: 1501.555±52.039 vs. stable-worse: 1461.304±63.562; p=0.03; t-test) differed between the two 9HPT groups, as did gray matter volume at follow-up (improved 1505.059 ±50.961 vs. stable-worse 865.57±41.352; p=0.063: t-test).
Eighteen patients had an improved T25FW score, compared to 27 whose score worsened or remained stable over the 12-month period. Deep white matter FLAIR/T2 lesion volume at baseline (improved: 0.43±0.507 vs. stable-worse: 0.827±0.561; p=0.03; t-test) and follow-up (improved: 0.429±0.503 vs. stable-worse: 0.864±0.603; p=0.02) differed between the two T25FW groups. The investigators did not observe any association between MUCCA and functional improvement measures.
Chaim Lebovits, CEO of BrainStorm says: “The important MRI correlations with measures of functional improvement in this matched natural history cohort will provide helpful context as we evaluate the clinical outcomes from our ongoing Phase 2 trial of NurOwn in patients with progressive MS and hopefully bring us a step closer to offering a new treatment option to individuals living with this devastating disease.”