The phase 3 started in May is designed to validate signs of efficacy seen in a 12-patient compassionate use program. Novartis also has an option to distribute remestemcel-L outside of Japan in GvHD and to co-fund its development and commercialization in other non-respiratory indications. In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score ³ 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions. Novartis, which has an approved cell therapy, may have the expertise to ensure remestemcel-L fares better when up for review by the FDA as a treatment for ARDS in COVID-19 patients. The relationship between the companies extends beyond COVID-19. SOURCE BrainStorm Cell Therapeutics Inc. Corporate Headquarters1325 Avenue of In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers. Program, Progressive "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications. The placebo response observed in this trial is unprecedented and the ability to show treatment benefit in this context provides evidence of the clinical value of NurOwn. Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously. Even after the bump, the stock remains down on the highs it hit before the complete response letter. Indeed, few potential ALS treatments make it to Phase 3 trials—the final stage of clinical testing before a drug is approved by the FDA for treatment. Given the heterogeneity of ALS, it is not surprising that measurement of treatment effect may be influenced by disease severity including the behavior of disease progression rates at the lower end of the scale. NEW YORK, Nov. 17, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study, Clinical trial did not meet statistical significance in primary efficacy endpoint, NurOwn® showed a clinically meaningful treatment response compared to placebo in a pre-specified subgroup, CSF biomarker analyses confirmed NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers, Company management to host conference call and live webcast today at 8:30 AM ET, Menu Reproduction in whole or part is prohibited. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Policies, University of Massachusetts Medical School, Investors & Novartis plans to run a phase 3 trial in non-COVID-19 ARDS patients, setting it up to address the broader unmet medical need. "The consistency of effect observed across NurOwn treated patients, including within pre-specified subgroups, highlights an important treatment effect in a fatal disease with very limited treatment options.