BrainStorm Cell (NASDAQ: BCLI) plunges ~70% in premarket on robust volume after the company announced that Phase 3 trial evaluating NurOwn for the treatment for Amyotrophic lateral sclerosis (ALS) did not reach statistically significant results. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453).  Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials.  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). These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. 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. Media, Patients & Autologous Cellular Therapy MSC-NTF Cells MSC-NTF Cell Production Publications Science Autologous Cellular Therapy Autologous cellular therapy has recently emerged as a credible and practical treatment option for cancer and other highly debilitating diseases. Caregivers, About Progressive These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. 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. Policy, Terms MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. We also carried out pre-specified statistical modeling designed to predict clinical response with high sensitivity and specificity based on ALS biomarkers and ALS Function and confirmed that NurOwn treatment outcomes could be predicted by baseline ALS function as well as key CSF neurodegenerative and neuroinflammatory biomarkers. "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. Value or growth stocks? 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). I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.". We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. The replay will be available for 14 days. 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. Holiday and New Year’s trading hours, ‘Santa Claus’ rally starts Thursday? MS, Patients & Dr. The MarketWatch News Department was not involved in the creation of this content. Topline data expected in 4Q 2020 . © Copyright 2019, BrainStorm Cell Program, Progressive BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS 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. 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. 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. CONTACTS Investor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1-646-465-1138cdavis@lifesciadvisors.com, Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com. 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. NEW YORK, Nov. 17, 2020 /PRNewswire via COMTEX/ -- 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). Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. 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. Dr. The company revealed topline results from its Phase 3 … "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. 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. It is important to fully explore this finding. Participants were followed for 28 weeks after treatment. 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 NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. Why few 7-session stretches are better for the stock market. ", "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials. A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. BrainStorm has completed the Phase 3 pivotal trial in ALS. The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. 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). 3 pivotal trial in progressive multiple sclerosis ( ALS ) 's forward-looking statements hours, Claus’... Multicenter trial in progressive multiple sclerosis ( ALS ) treatment response in a pre-specified subgroup of with!, who kindly supported the biomarker study '' March 2019 NurOwn® technology platform ( MSC-NTF! ( p=0.453 ) technology platform ( autologous MSC-NTF cells in patients with progressive MS ( NCT03799718 ) enrollment. 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