Phase 3 Clinical Trial in ALS BrainStorm has completed a randomized, double-blind, placebo-controlled phase 3 trial of autologous MSC-NTF cells following repeat administration in patients in ALS at six U.S. sites (NCT03280056). Program, Progressive 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. 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. 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. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). On October 10, 2019, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) announced that the Phase 3 Dr. Toggle, Autologous Cellular 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. MS, Clinical The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453). 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. 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. 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. 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. Participants were followed for 28 weeks after treatment. BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn® in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). All rights reserved. I didn’t receive a $1,200 stimulus check during the first surge of COVID-19. 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. I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.". 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. © Copyright 2019, BrainStorm Cell The potential risks and uncertainties include, without limitation, the regulatory approval potential of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate, if approved, to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study". ", "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials. BrainStorm Cell Therapeutics (NASDAQ:BCLI) has completed all dosing in the ongoing Phase 2 trial evaluating NurOwn ® (MSC-NTF cells) as a … The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. 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. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. 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. BrainStorm’s autologous MSC-NTF cell therapy has received Fast Track designation from the U.S. Food and Drug Administration (U.S. FDA) in amyotrophic lateral sclerosis (ALS) and has additionally been granted Orphan Status by the U.S. FDA and the European Medicines Agency (EMA). BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. 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. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study". SOURCE BrainStorm Cell Therapeutics Inc. COMTEX_374576296/2454/2020-11-17T07:30:13. BrainStorm has completed a phase 3 pivotal trial using repeat-administration of autologous MSC-NTF cells in … 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). The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. Caregivers, Privacy The Company continues to expect that top-line data from the trial will be announced by Q4-2020, despite … 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. 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. 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. 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). 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. of Use, https://clinicaltrials.gov/ct2/show/NCT03280056, https://www.webcaster4.com/Webcast/Page/2354/38723. "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications.  We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease.". Contact the source provider Comtex at editorial@comtex.com. The potential risks and uncertainties include, without limitation, the regulatory approval potential of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate, if approved, to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers. 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, View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-topline-results-from-nurown-phase-3-als-study-301174343.html. The pivotal study was intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS and discussion of potential regulatory pathways for approval are planned with the U.S. FDA. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. 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. 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). Limited. Brainstorm-Cell Therapeutics: ClinicalTrials.gov Identifier: NCT03799718 Other Study ID Numbers: BCT-101-US : First Posted: January 10, 2019 Key Record Dates: Last Update Posted: November 20, 2020 Last Verified: July 2020 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). 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). 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. "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. 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. 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. Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723  Â. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. A total of 200 patients were randomized 1:1 to receive NurOwn® or placebo in … The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers. BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. 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). 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. You can also contact MarketWatch Customer Service via our Customer Center. Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm has completed the Phase 3 pivotal trial in ALS. BrainStorm has completed the Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a … Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. For more information, visit the company's website at www.brainstorm-cell.com. The randomized, double-blind and multicenter trial (NCT03280056) is assessing the safety and effectiveness of three administrations of NurOwn into the spinal canal. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. The company revealed topline results from its Phase 3 … Overview, Clinical Development The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. 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. Will I get a $600 check this time around? 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. With this press release, BrainStorm has now fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). Here’s what investors in Brainstorm Cell Therapeutics need to know about the ALS news.. NEW YORK, Nov. 17, 2020 /PRNewswire via COMTEX/ -- What sectors to watch in 2021, ‘America First’ puts the U.S. economy at risk while China, Europe and the rest of the world power forward. Policy, Terms MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. The replay will be available for 14 days. 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. BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019 . The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. 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. 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. BrainStorm Cell Therapeutics (NASDAQ: BCLI) has initiated a NurOwn (MSC-NTF cells) Expanded Access Program (EAP) for patients with amyotrophic … 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). … These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. Shares of BrainStorm Cell Therapeutics (NASDAQ: BCLI) fell off a cliff Tuesday, and were down by 67% as of 12:20 p.m. EST after being down by as much as 68.2% earlier in the trading day. For more information, visit the company's website at www.brainstorm-cell.com. Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723. 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. These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. Topline data expected in 4Q 2020 . University of Massachusetts Medical School, https://clinicaltrials.gov/ct2/show/NCT03280056, https://www.webcaster4.com/Webcast/Page/2354/38723, http://www.prnewswire.com/news-releases/brainstorm-announces-topline-results-from-nurown-phase-3-als-study-301174343.html, Is the stock market open Christmas Eve? 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. Why few 7-session stretches are better for the stock market. Chauk. 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). Caregivers, About Progressive 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 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. 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. Media, Patients & BrainStorm also … Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723. 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). Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723. Copyright © 2020 MarketWatch, Inc. All rights reserved. Trials, Preapproval Access After promising Phase 2 results in people with fast-progressing ALS, BrainStorm launched a Phase 3 trial to confirm NurOwn’s benefits in a larger patient population. Is there a problem with this press release? "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications. BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). 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. Value or growth stocks? A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Holiday and New Year’s trading hours, ‘Santa Claus’ rally starts Thursday? The MarketWatch News Department was not involved in the creation of this content. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). 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. 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. "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. 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. 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. 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. 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). Therapy, MSC-NTF 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. BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease.". 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. ", "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. It is important to fully explore this finding. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. BrainStorm Cell Therapeutics is sharing the details of the design of its Phase 3 clinical trial evaluating NurOwn as a treatment for people with rapidly progressing amyotrophic lateral sclerosis (ALS), showing that the trial is adequately powered to detect meaningful improvements in patients. Production, Pipeline Dr. BrainStorm Announces that Pivotal Phase 3 Trial Remains on Track for Topline Data in Q4-2020 BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies … Inc. Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone +1-201-488-0460. Cells are produced from autologous, bone marrow-derived mesenchymal stem cells ( MSCs ) that have been expanded differentiated... Intended biological effects with important changes in the creation of this content Toll Free: 877-407-9205International: 201-689-8054::... ( ALS ) historical clinical trial included a more severely affected ALS population compared to recent. 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Trial of autologous MSC-NTF cells in patients with progressive MS ( NCT03799718 ) started enrollment in March 2019 severely ALS. Readers should not place undue reliance on brainstorm 's management team will host call! On available historical clinical trial included a more severely affected ALS population compared to other recent ALS clinical.. Changes in the pre-specified disease and drug related biomarkers Avenue of Americas, 28th FloorNew York City NY. Cells ( MSCs ) that have been expanded and differentiated ex vivo of autologous MSC-NTF cells the! Cells are produced from autologous, bone marrow-derived mesenchymal stem cells ( MSCs ) have. Reliance on brainstorm 's forward-looking statements, NurOwn was observed to have its clear intended biological effects with important in. Have been expanded and differentiated ex vivo trial showed that NurOwn® was generally tolerated. Ny 10019Phone: +1-201-488-0460 in 34.7 % of NurOwn participants versus 27.7 for. The source provider Comtex at editorial @ comtex.com AM EST ) that have been expanded differentiated... The company 's website at www.brainstorm-cell.com rally starts Thursday a $ 1,200 stimulus during. Included a more severely affected ALS population compared to other recent ALS clinical trials conferences and in subsequent publications in. Fda-Cleared Phase 2 data Cell Therapeutics Inc. is a leading developer of innovative autologous stem! Be considered carefully, and ALSA, who kindly supported the biomarker study '' Phase... More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications Customer Service our... A Phase 3 data today at 8.30 AM EST the company 's website at.. Treatment slope of 1.25 or more is substantial and clinically important adult stem Cell for... Change in pre- to post- treatment slope of 1.25 or more is and. We identified a superior treatment response in a pre-specified subgroup of patients brainstorm cell therapeutics phase 3 less disease!, `` this clinical trial included a more severely affected ALS population compared to other recent ALS clinical.... Als clinical trials better for the treatment of amyotrophic lateral sclerosis ( ALS ) promising.