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BrainStorm Announces Final Analysis of Phase 2a ALS Study Showing Nearly All Subjects Experienced Clinical Benefit from NurOwn(TM)
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.
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 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.
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.
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 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.
www.globenewswire.com/news-release/2020/...proval-in-ALS.html
old.nasdaq.com/de/symbol/bcli/real-time
old.nasdaq.com/de/symbol/bcli/real-time
Man kann ja immer noch auf das Pferd setzen. Die Firma ist doch gerade am Anfang mit erfolgreicher Therapie. Ist so wie bei Amazon, Google etc. - am Anfang sind die auch gestiegen. Da hätte man sagen können "Ist eh schon hoch der Kurs, lohnt sich nicht der Einstieg". Aber siehe da es ging immer höher.
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.
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.
Hab mir mal ne kleine Posi von 60 Stück geholt.
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.
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.
Hab ma bissl twitter zwecks NurOwn durchforscht, i gloag ALS is damit Geschichte.
Und mal schauen wie die Studien für MS verlaufen.
Und mal schauen wie die Studien für MS verlaufen.
Brainstorm Cell Therapeutics Inc (BCLI) CEO Chaim Lebovits on Q2 2020 Results - Earnings Call Transcript
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.
...
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.
...
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.
...
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.
mobile.twitter.com/DeborahMidgley1/status/1305532989816934401
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'.
...
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."
If You Can Dream
tweedthoughts.com/2020/08/25/...click=https://t.co/qtEEjXtMNS
tweedthoughts.com/2020/08/25/...click=https://t.co/qtEEjXtMNS
NurOwn® (autologous MSC-NTF cells) in ALS- phase 3 clinical trial update - Ralph Kern
m.youtube.com/watch?feature=emb_title&v=kdgfyxIyz4U
m.youtube.com/watch?feature=emb_title&v=kdgfyxIyz4U
die Vermarktung wird schonmal weiter geplant/vorbereitet
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
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.
...
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.
...
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.
...
a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.
BrainStorm Details Phase 3 Trial Design of NurOwn for Rapidly Progressing ALS
alsnewstoday.com/news-posts/2020/10/12/...ly-progressing-als/
alsnewstoday.com/news-posts/2020/10/12/...ly-progressing-als/
Keine ahnung, hab nixs gefunden, bin aber grad im urlaub und schau nur eingeschränkt.
An den trials scheints nicht zu liegen.
An den trials scheints nicht zu liegen.
sind es Gewinnmitnahmen. Scheint sich zu stabilisieren...
Kurs schrint sich beruhigen und
Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn®
ir.brainstorm-cell.com/...Stem-Cell-Platform-Therapy-NurOwn-R
Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn®
ir.brainstorm-cell.com/...Stem-Cell-Platform-Therapy-NurOwn-R
Mal was von twitter wie nurown anschlägt.
mobile.twitter.com/sandrac37082124/status/1326915288357597186
ALS patient. Years without walking and now he's starting to do it thanks to injections with #NUROWN.
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"
ir.brainstorm-cell.com/...lts-from-NurOwn-R-Phase-3-ALS-Study
Ich wusst scho warum ich eigentlich lieber die Finger von Pharmas lassen sollt.
Wenn ichs richtig les wurde primär punkt nur knapp verfehlt und es laufen Gespräche mit der FDA.
Naja ma guggn.
Wenn ichs richtig les wurde primär punkt nur knapp verfehlt und es laufen Gespräche mit der FDA.
Naja ma guggn.
typisch Pharma. Da sind hohe Risiken, aber auch übertreibungen im Kurs inclusive. Mal sehen, wie es in nächster Zeit weiter geht...
www.insidermonkey.com/blog/...eutics-inc-bcli-anymore-891736/
old.nasdaq.com/de/symbol/bcli/real-time
old.nasdaq.com/de/symbol/bcli/real-time
www.fool.com/investing/2021/02/04/...utics-blasted-277-highe/
FDA Statement
"With the recent completion of a randomized phase 3 controlled clinical trial comparing NurOwn to placebo, it has become clear that data do not support the proposed clinical benefit of this therapy. Data indicated that none of the primary or secondary endpoints were met in the group of patients who were randomized."
www.fda.gov/vaccines-blood-biologics/...s-product-development
42 Mio. $ Cash zum Jahresende 2020; ein Verlust von 32 Mio. $ und eine MK von 119 Mio. $.
Allerdings schon bei 4,75$ gewesen im Tageshoch, danach stetig runter.
www.benzinga.com/general/biotech/21/03/...ple-sclerosis-study
www.benzinga.com/general/biotech/21/03/...ple-sclerosis-study
So nachdem ich damals raus bin, hab ich mal ne kleine risikposition wieder gehollt.
Einfach bissl hoffnung das nu langsam der boden erreicht ist.
Da ich das jetzt mehr als zock seh könnts auch sein das ich nächste woche schon wieder raus bin, ma schaun.
Vielleicht hat mir die sonne am see auch grad blos das gehirn verbraten ^^
Einfach bissl hoffnung das nu langsam der boden erreicht ist.
Da ich das jetzt mehr als zock seh könnts auch sein das ich nächste woche schon wieder raus bin, ma schaun.
Vielleicht hat mir die sonne am see auch grad blos das gehirn verbraten ^^
Die MK von 113 Mio. $ erscheint mir immer noch sehr sportlich. Das ALS Programm steckt in der Sackgasse und ob die Indikation "Multiple Sclerosis" BLCI retten kann bleibt abzuwarten.
brainstorm-cell.com/pipeline-overview/
brainstorm-cell.com/pipeline-overview/
BrainStorm Cell Therapeutics erhält von der FDA ein Ablehnungsschreiben für seinen neuen Zulassungsantrag für Biologika für NurOwn zur Behandlung von ALS.
ir.brainstorm-cell.com/...for-NurOwn-for-the-treatment-of-ALS
ir.brainstorm-cell.com/...for-NurOwn-for-the-treatment-of-ALS
"unter Protest" soll nun ein Adcomm durchgeführt werden
ir.brainstorm-cell.com/...r-NurOwn-R-for-the-Treatment-of-ALS
Zahlen für FY22
- keine Umsätze
- Verlust 24 Mio. $
- Cash 3 Mio. $
- MK 89 Mio. $
ir.brainstorm-cell.com/...lts-and-Provides-a-Corporate-Update
Der krass niedrige Cashbestand birgt große Gefahren, dass es hier zu einer weiteren Verwässerung kommen wird/könnte. Hätte ich Aktien von BCLI (und wäre im Plus) würde ich zu diesen Kursen verkaufen. Kann mir nur schwer vorstellen, dass die FDA "begeistert" von diesem "erstrittenen" Adcomm-Meeting ist.
Zahlen für Q2/23
- keine Umsätze
- Verlust 5 Mio. $
- Cash 1 Mio. $
- MK 73 Mio. $
-FDA advisory committee (ADCOM) meeting to discuss NurOwn® for Amyotrophic Lateral Sclerosis (ALS) scheduled for September 27, 2023
-BrainStorm's Biologics License Application (BLA) for NurOwn has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023
ir.brainstorm-cell.com/...sults-and-Provides-Corporate-Update
7,5 Mio. $ Offering im Juli
Briefing Dokumente zum AdComm Meeting
www.fda.gov/advisory-committees/...-2023-meeting-announcement
Kursturz mit Ansage!
vernichtende Abstimmung
Die Frage über die abgestimmt werden sollte lautete: "Zeigen die Daten durch die vorgelegten Beweise einen substanziellen Beweis für die Wirksamkeit?"
Ergebnis:
- 17x Nein
- 1x Ja
- 1x Enthaltung
Damit dürfte eine Zulassung nun auch formal vom Tisch sein, die Chancen standen vorher schon schlecht. Noch dramatischer ist die Cashlage des Unternehmens. Meiner Meinung nach endet das hier in einer "Pleite".
www.biospace.com/article/...therapy-in-nearly-unanimous-vote/
Ich glaube zu diesem Unternehmen ist alles gesagt.
BCLI zieht die BLA für NurOwn zurück
ir.brainstorm-cell.com/...an-for-NurOwn-as-a-Treatment-of-ALS
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