|View printer-friendly version|
|In-Depth Analyses Presented at International Symposium on ALS/MND Suggest Strong Biological Effect for NurOwn®; Evidence of Halting of Disease Progression|
In the Phase 2 trial, levels of neurotrophic factors and inflammatory markers were measured in cerebral-spinal fluid (CSF) samples collected from patients. In the samples of those patients treated with NurOwn, a statistically significant increase in levels of neurotrophic factors VEGF, HGF and LIF was observed from pre- to post-transplantation. There was also a statistically significant reduction in inflammatory markers (MCP-1 and SDF-1) over this period, in patients treated with NurOwn® and this was not observed in the placebo group.
Dr. Berry also presented the pre-specified responder analyses from the Phase 2 trial which examined percentage improvements in post treatment of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope compared to pre-treatment slope. These analyses showed that, in the NurOwn® treated group, a greater number of patients achieved the high threshold of 100% improvement in the post-treatment vs. pre-treatment slope, compared with the placebo group. The definition of these responders is that their disease symptoms were essentially halted for the period of the treatment effect or they achieved a positive improvement on their ALSFRS-R score. Moreover, in the pre-specified subgroup that was defined in order to exclude subjects whose disease was progressing slowly, this effect was even more pronounced.
"This Phase 2 trial demonstrated clinical meaningful improvements in disease symptoms as measured by the well-established ALSFRS-R scale", stated Dr.
The Phase 2 trial was a randomized, double-blind, placebo-controlled multi-center study designed to evaluate the safety and efficacy of NurOwn® in 48 ALS patients. It was conducted at three sites in the U.S:
Dr. Berry's presentation is posted on the "Events and Presentations" page of the Brainstorm company website (www.brainstorm-cell.com).
About the International Symposium on ALS/MND
Safe Harbor Statement
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/in-depth-analyses-presented-at-international-symposium-on-alsmnd-suggest-strong-biological-effect-for-nurown-evidence-of-halting-of-disease-progression-300378116.html