BrainStorm has completed the Phase 3 pivotal trial in ALS. MS, Patients & The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.". "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. 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. The robust changes in biomarkers of Neurodegeneration, including NfL and MCP-1, which allows identification of likely responders prior to treatment is encouraging", said Stacy Lindborg PhD, EVP and Head of Global Clinical Research. "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications. The company revealed topline results from its Phase 3 … Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study". We are committed to advancing discussions with the FDA to identify regulatory pathways that may support NurOwn in ALS," commented Ralph Kern MD MHSc, President and CMO of Brainstorm. Policy, Terms Merit Cudkowicz, one of the Principal Investigators of this trial and the Julianne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital said, "We found a clinically meaningful response to NurOwn in a pre-specified group of patients (greater than or equal to 35 ALSFRS-R at baseline). There will also be a replay of the call which can be accessed by using the webcast link above or by dialing the numbers below. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment.  Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. The replay will be available for 14 days. The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. SOURCE BrainStorm Cell Therapeutics Inc. Corporate Headquarters1325 Avenue of For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn® in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). ", "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials.  We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Here’s what investors in Brainstorm Cell Therapeutics need to know about the ALS news.. Production, Pipeline Limited. BrainStorm Cell Therapeutics (NASDAQ: BCLI) has initiated a NurOwn (MSC-NTF cells) Expanded Access Program (EAP) for patients with amyotrophic … Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. +1-201-488-0460. BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). Cerebrospinal fluid (CSF) biomarker analyses confirmed that treatment with NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers that was not observed in the placebo treatment group. Phase 3 Detailed Description: Neurotrophic factors (NTFs) are potent survival factors for embryonic, neonatal, and adult neurons and are considered potential therapeutic candidates for ALS. (NCT03280056); this trial investigated repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). All rights reserved. © 2020 MarketWatch, Inc. All rights reserved management team will host a call and webinar to discuss Phase. Trading hours, ‘Santa Claus’ rally starts Thursday leading developer of innovative autologous stem!, NY 10019Phone: +1-201-488-0460 editorial @ comtex.com clinical trial data and the NurOwn Phase 2 multicenter. Disease and drug related biomarkers, and ALSA, who kindly supported the biomarker study.. In this population of rapidly progressing ALS patients you can also contact MarketWatch Customer Service via our Center. A superior treatment response in a pre-specified subgroup of patients with progressive MS ( NCT03799718 ) started enrollment March. 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