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FrenchFries

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NEW YORK (TheStreet) -- Shares of Brainstorm Cell Therapeutics (BCLI) soared 20.88% to $4.69 on higher-than-average volume in morning trading Wednesday ahead of the biotech company's data release on Monday.

Brainstorm intends to release the final results from its Phase 2a trial of its stem cell therapy NurOwn on Monday. The company describes NurOwn as an "autologous, adult stem cell therapy technology" designed to treat ALS, also known as Lou Gehrig's Disease.

The company will host a conference call on Monday to discuss the results.

"We are very excited to share the final results of this study," said Brainstorm's CEO Tony Fiorino, MD, PhD, in a company statement. "Professor Karussis presented a very positive and well-received interim analysis of this study at the Joint Congress of European Neurology in June 2014, and the final results include data from several additional subjects and analyses conducted by our independent statisticians."

"The interim analysis of this study, and results of our prior phase 1/2 study, have shown that a single dose of NurOwn™ is safe and can provide clinically meaningful benefits to ALS patients, such as a reduction in the rate of progression, and in some patients, actual improvements in function," Fiorino continued. "The final results will extend these findings and allow us to move forward with a presentation and publication strategy so that we may share these important data with our medical and scientific colleagues."
 
>The company will host a conference call on Monday to discuss the results.

time & number?
 
All the infos to follow the conference are on their web site :
BrainStorm Cell Therapeutics - December 22, 2014
 
from Bloomberg an hour ago:

The study achieved its primary endpoint in demonstrating that NurOwn™ 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™. 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™, 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™ 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™ 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™ 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™, 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™. 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™ 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™ 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™ (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™ 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.

Conference Call Information

Monday, January 5, 2015 at 8:30 AM Eastern Standard Time

US Toll Free:
Israel Toll 888-401-4668
Free: 180-924-5906
Other 719-325-2495
International: 6267823
Conference ID: https://viavid.webcasts.com/starthere.jsp?ei=1051486
Webcast:

A replay will be available through January 19, 2015:

Toll Free: 877-870-5176
International: 858-384-5517
Replay PIN: 6267823
-----------

Stock is down 20% today.
 
Danged mod. The press release from an hour ago is on Bloomberg dt com . Search BCLI . Stock is down today.
 
Is it just me or does that report read as though it was written hastily before bed one night?

I don't want to sound like I'm bagging this, but it's about the most unscientific sounding report I've read, and contains very strange language errors.

I'd like to believe very much that their stem cells are taking us in the right direction for a true treatment.
 
Placebo effect?
 
pretty thin, but I'm dyin' here, so who am i toquestion?
 
pretty funny Max...love that humor
 
So can we ask for treatment based on compassionate care?
 
It seems ironic to me that the FDA might be concerned with safety issues before okaying these possible ALS treatments for market use when you see products already being advertised on tv such as for COPD where they have put warnings at the end of the commercial that you might contract this illness, that illness and such. It would seem that there would already exist a pretty low threshold for such "safety" concerns. Of course "safety" issues often really means concerns for possible lawsuits by surviving relatives.
 
to me, this approach is the one which seems to be the more 'direct and understandable' action in reasearch these days.
let imagine that a person is a wall, and als the cause which progressively destroys the wall. then, this technique is like renew bricks that have been destroyed, over and over : we don't need to fully understand the reason why bricks are progressively destroyed if we manage to keep the wall standing... it's a little brute force technique but this could work and may be combined with any other treatment...

however, I do not know if "nurown" injection is a quick, cheap, easy process... and that multiple injection will allow to reverse conditions... I hope so...
 
It's not really available, my understanding is that it's - harvesting from bone marrow in hip, then waiting weeks for it to "cook" then installed in your muscle, and spinal "sack" - sorry for the unscientific wording here.

When I say unavailable, it's only been done on a double blind placebo with relatively small amounts of people.

Have only heard of compassionate use for 1 person in Israel.
 
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