Brainstorm Cell Therapeutics Inc
WKN: A40M9K / ISIN: US10501E3009BrainStorm Cell Therapeutics!
NEW YORK and PETACH TIKVAH, Israel, Jan. 5, 2014, 2015 /PRNewswire via COMTEX/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced positive final results from its phase 2a clinical trial of NurOwn(TM) in amyotrophic lateral sclerosis (ALS) patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem.
http://photos.prnewswire.com/prnvar/20141006/150511
The study achieved its primary endpoint in demonstrating that NurOwn(TM) is safe and well-tolerated at doses up to 2 million cells per kilogram administered intrathecally (IT) and 48 million cells administered intramuscularly (IM).
Importantly, nearly all subjects in this study experienced clinical benefit from treatment with NurOwn(TM). Of the 12 subjects with three or more months of follow-up, 92% experienced an improvement in the rate disease progression for the three month period after administration of NurOwn(TM), as measured by ALS Functional Rating Score-Revised (ALSFRS) or forced vital capacity (FVC). Fifty percent had an improvement in the slope of the ALSFRS score, and 67% had an improvement in the slope of the percent-predicted FVC.
NurOwn(TM) slowed the progression of ALS in this study, as indicated by an improving slope of both the mean ALSFRS and mean FVC curves after therapy. On ALSFRS, NurOwn(TM) slowed the rate of progression by 45%, from 1.41 points per month during the run-in period to 0.78 points per month for the three months following treatment, and by 57% to 0.60 per month for the six months following treatment. NurOwn(TM) had a similarly strong effect on the progressive loss of lung function - the rate of decline in percent-predicted FVC was reduced by 73%, from an average of 2.60% per month during the run-in period to just 0.70% per month for the three months after treatment, and by 67% to 0.86% per month for the six months following treatment.
"We are gratified to have the final data from this study and are very encouraged by the results," commented BrainStorm's CEO Tony Fiorino, MD, PhD. "This study not only extends our earlier phase 1/2 findings regarding the safety of NurOwn(TM), but also provide a consistent and highly promising picture of NurOwn's efficacy. In particular, I would highlight that we observed not only a highly meaningful reduction in ALS progression on mean ALSFRS and FVC, but we saw subjects with prolonged stabilization and even improvements in function, and all this was achieved with just a single dose of NurOwn(TM). We are excited to proceed to a multi-dose study to see if these positive results can be amplified and extended by administering repeated doses."
Professor Dimitious Karussis of Hadassah Medical Center and the principal investigator of the trial, noted "This is the second study of NurOwn(TM) I have completed in ALS patients, and my excitement for these cells as a possible treatment for ALS continues to grow. I am impressed by the consistency of benefit of IT administration we have seen in both studies, and we saw in this study that almost every subject experienced clinical benefit, either on ALSFRS, FVC or both measures. I believe that if future studies demonstrate a similar magnitude of benefit, NurOwn(TM) will become an important treatment option for patients suffering from ALS."
About the Phase 2a Study
This was a single-arm, dose escalating study of NurOwn(TM) (also referred to as MSC-NTF cells) in ALS (see https://clinicaltrials.gov/show/NCT01777646 for more study details). The study enrolled 14 early-stage ALS patients into three ascending dose cohorts; each subject received NurOwn(TM) cells via IT and IM administration after a three month run-in period, and was then followed for six additional months after treatment. Subjects in this study were assessed at monthly visits by ALSFRS score and for respiratory function by FVC. The rate of decline for these measures was determined by calculating the slope of the linear regression line for the run-in period, the three month follow-up period, and the six month follow-up period.
Ich warte auf Rücksetzer und steige hier ab und zu ein und dann werden es genug Stücke, um bei den kommenden noch höheren Anstieg dabei zu sein.
Da ich Pharma eigentlich versuche zu meiden nur ne kleine Posi.
Auch die Vermarktung vorallem im Bereich ALS schätze ich als gering ein (kann ich nicht schwer einschätzen, aber im Milliardenbereich liegts nicht).
Aber die Phase 3 scheint bisher gut zu laufen.
Und da mein Vater selbst ALS hatte musst ich hier zumindest klein rein.
Die 200 Leute sind ausgerollt und scheint super zu laufen, Q4 müsst dann die TopLine Ergebnisse geben.
Und mal schauen wie die Studien für MS verlaufen.
Hier mal was das bedeutet
https://www.congress.gov/bill/116th-congress/...bill/7071?s=1&r=7
Brainstorm Cell Therapeutics Inc (BCLI) CEO Chaim Lebovits on Q2 2020 Results - Earnings Call Transcript
https://seekingalpha.com/article/...-on-q2-2020-results-earnings-call
We have never been in such a strong financial position. We have no debt, no convertibles or the like, we today are close to $35 million cash on hand. I will begin this morning’s call with some introductory remarks and general corporate updates at BrainStorm.
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Thank you Chaim and thank you everyone for joining us today on the earnings call. Let me start with an update on our Phase III pivotal trial of neuron in ALS. As a reminder, the trial is being conducted at six ALS of excellence in the U.S., it has enrolled approximately 200 participants, randomized one-to-one to receive three doses of neuron or placebo. These were administered over four months and then participants in the trial are followed for a total of 28 weeks.
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At BrainStorm, we are staffing up a highly experienced team. And we are very busy on a day-to-day basis planning and executing to support data readouts on all pre-BLA activities. Our clear focus is to expedite this process. We want to be able to submit a Biologic License Application or BLA with the FDA as soon as possible after the top line data is available.
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I’m also happy to report that our progressive MS trial is now fully enrolled. Despite facing severe COVID-19 hospital restrictions in the spring, we still expect all study treatments to be completed by the end of this year.
Brainstorm Announces Grant of a New Japanese Patent for NurOwn®
https://www.ariva.de/news/...ant-of-a-new-japanese-patent-for-8739519
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the Japanese Patent Office (JPO) has granted Brainstorm's Japanese Patent, number: 6,753,887, titled: 'Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors'.
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David Setboun, PharmD MBA, EVP and Chief Operating Officer, added: "Having our cell therapy product patented in Japan will increase our ability to enter into new commercial partnerships for NurOwn® in Japan."
https://tweedthoughts.com/2020/08/25/...click=https://t.co/qtEEjXtMNS
https://m.youtube.com/watch?feature=emb_title&v=kdgfyxIyz4U
Bin echt auf November, auf die Resultate, gespannt.
BrainStorm Appoints William K. White as Senior Vice President, Head of Market Access & Pricing
https://www.ariva.de/news/...s-william-k-white-as-senior-vice-8772856
BrainStorm Announces Scientific Presentation at the Annual NEALS Meeting
https://www.ariva.de/news/...tific-presentation-at-the-annual-8775779
announced the presentation of a poster titled, "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting, being held virtually.
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Compelling Phase 2 data showed that a single NurOwn® administration slowed disease progression in this patient population, and the current Phase 3 trial aims to confirm this effect in a larger study cohort and show that its duration can be extended through repeated administrations.
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BrainStorm to Present at the 2020 Cell & Gene Meeting on the Mesa
https://www.ariva.de/news/...he-2020-cell-amp-gene-meeting-on-8806252
Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the 2020 Cell & Gene Meeting on the Mesa, being held virtually October 12-16, 2020.
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a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.
https://alsnewstoday.com/news-posts/2020/10/12/...ly-progressing-als/
An den trials scheints nicht zu liegen.
Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn®
https://ir.brainstorm-cell.com/...Stem-Cell-Platform-Therapy-NurOwn-R
https://mobile.twitter.com/sandrac37082124/status/1326915288357597186
ALS patient. Years without walking and now he's starting to do it thanks to injections with #NUROWN.
Topline Results from NurOwn® Phase 3 ALS Study
"Clinical trial did not meet statistical significance in primary efficacy endpoint"
https://ir.brainstorm-cell.com/...lts-from-NurOwn-R-Phase-3-ALS-Study
