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Brainstorm Cell Therapeutics Inc (Public, OTC:BCLI)

88 Posts
Pagina: «« 1 2 3 4 5 | Laatste | Omlaag ↓
  1. De Troon Jan 12 oktober 2020 21:26
    Ik hou ze, er stond v d week wel een Engels artikel dat er maar twee investeringsbedrijven in zitten nog te weinig naar mijn zin en half oktober wordt phase 3 goedgekeurd hopen we! Daarom nu de daling daarna omhoog hetzelfde met axsome daar blijf ik ook in zitten, mijn ziekte is slecht chemo in helm zkh
  2. Missolapola 20 oktober 2020 20:02
    quote:

    De Troon Jan schreef op 12 oktober 2020 21:26:


    Ik hou ze, er stond v d week wel een Engels artikel dat er maar twee investeringsbedrijven in zitten nog te weinig naar mijn zin en half oktober wordt phase 3 goedgekeurd hopen we! Daarom nu de daling daarna omhoog hetzelfde met axsome daar blijf ik ook in zitten, mijn ziekte is slecht chemo in helm zkh

    Chemo maakt je echt ziek maar dat is alleen om nadien beter te kunnen worden.
    Hou de moed erin Jan, ook al ken ik je niet, ik denk aan jou.
  3. Missolapola 17 november 2020 15:55
    BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study
    News Release Issued: Nov 17, 2020 (7:30am EST)

    To view this release online and get more information about Investors & Media - BrainStorm Cell Therapeutics visit: ir.brainstorm-cell.com/2020-11-17-Bra...

    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

    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). Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing 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.

    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. 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).

    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.

    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 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.

    Dr. 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). A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. 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. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers."

    "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. 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."

    "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. 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. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study".

    "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. 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."
    .....
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