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. Overview, Clinical Development It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (Prof. MS, Patients & Is there a problem with this press release? Program, Progressive The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data.  The FDA will review the data to see if there is a path forward to support approval" said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We would like to sincerely thank the patients, their families and caregivers, investigators and staff who participated in this study, as their dedication and hard work allowed for the study's on-time completion despite the ongoing COVID-19 pandemic.  I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial."Â. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. 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. 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). 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.  In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn. Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723. I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.". Limited. 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). 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 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. 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. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating 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). Dr. The secondary efficacy endpoint measuring average change in ALSFRS-R total score from baseline to Week 28, was -5.52 with NurOwn versus -5.88 on Placebo, a difference of 0.36 (p= 0.693). 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. NEW YORK, July 2, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that final participant dosing has been administered in the Phase 3 pivotal trial of NurOwn® (MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Policy, Terms The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. Caregivers, About Progressive 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). Cells, MSC-NTF Cell The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. "The findings from this clinical trial demonstrated that NurOwn treatment was associated with a clinically meaningful treatment response and consistent biomarker effects in known ALS disease pathways and that the ability of the clinical trial to demonstrate treatment effects compared to placebo are influenced by baseline disease status, as revealed through ALS function and key biomarkers. (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). Participants were followed for 28 weeks after treatment. 1 year ago. The randomized, double-blind and multicenter trial (NCT03280056) is assessing the safety and effectiveness of three administrations of NurOwn into the spinal canal. It is important to fully explore this finding. Topline Data from Phase 3 ALS Trial Before End of November 2020. We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. Dr. Copyright (C) 2020 PR Newswire. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. Statements in this announcement other than historical data and information, including statements regarding the topline results from the NurOwn® Phase 3 ALS study and future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. The replay will be available for 14 days. (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). BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. BrainStorm has completed the Phase 3 pivotal trial in ALS. 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. Therapy, MSC-NTF 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). Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at www.ir.brainstorm-cell.com and clicking on the conference call link. 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. +1-201-488-0460. The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. Copyright © 2020 MarketWatch, Inc. All rights reserved. Website by BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that all dosing has been completed in the ongoing Phase 2 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for progressive MS. Topline data expected in 4Q 2020 . Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. BrainStorm Cell Therapeutics announced that the Phase 3 clinical trial of its cell therapy candidate NurOwn in 200 amyotrophic lateral sclerosis (ALS) patients is fully enrolled and treatment is underway.. NEW YORK, Nov. 17, 2020 /PRNewswire via COMTEX/ -- The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453). BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). of Use, https://clinicaltrials.gov/ct2/show/NCT03280056, https://www.webcaster4.com/Webcast/Page/2354/38723. Summary of Phase 2 Trials of BrainStorm’s Autologous MSC-NTF Cellular Therapy in ALS Autologous MSC-NTF cells have been administered to a total of about 70 ALS patients in three completed clinical trials, including two open-label trials in Israel and a multicenter, double-blind, placebo-controlled trial in the United States. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results. "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. BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn® in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). BrainStorm has completed the Phase 3 pivotal trial in ALS. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. 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