Upcoming Key Clinical Data Catalyst Makes BCLI One To Bet On
(Thomson Reuters ONE) -
This morning, BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI) announced the
financing our readers had been anticipating. With net proceeds to BrainStorm of
approximately $4.78 million. The next pending catalyst could send shares of the
company higher.
As we first readers this weekend, shares of the emerging Israeli firm had
started to gain momentum earlier this month, after a televised news report
highlighted the case of a very conservative Israeli Rabbi named Refael
Shmulevitz.
According to various reports on the subject, Israeli Channel Two audiences were
moved to see the ailing rabbi, who had been diagnosed with ALS, able to walk and
talk again after being treated with Brainstorm's investigative therapy, NurOwn.
Brainstorm's patients are transplanted with stem cells derived from their own
bone marrow and then treated with the firm's proprietary stem cell technology.
Amyotrophic lateral sclerosis, or ALS, is a disease of the nerve cells in the
brain and spinal cord that control voluntary muscle movement. ALS is also known
here in the U.S. as Lou Gehrig's disease.
By all accounts, Rabbi Shmulevitz was diagnosed with ALS four months ago at the
Mayo Clinic and was told he had only two to four years to live. He lost the
ability to talk clearly and was confined to a wheelchair. He stopped speaking
publicly and, basically, retired from most of his sctivities. Within a few weeks
following injection with BCLI's NurOwn cells, the patient showed dramatic
improvement in a variety of functions including breathing, speech, walking,
muscular strength, and overall well-being according to Professor Dimitrios
Karussis of the Neurology Department at The Hadassah Medical Center in
Jerusalem. Karussis is the principal investigator of BrainStorm's current phase
I/II clinical trial.
"While we cannot draw scientific conclusions based on the outcome of an
individual patient, these results are extremely encouraging," Karussis added.
BrainStorm is a company that we have been actively tracking for at least six
months. Still, I could not find logical reason to recommend the firm as a trade
or investment candidate until now. Don't get me wrong, I was very bullish on the
firm after carefully reading through clinical data results which were released
in January 2012, but we knew there was more to this story and we could not, in
good faith, recommend the firm at that time. It was reported at that time, that
even though the firm was only conducting a "safety trial," the early clinical
follow up of the patients treated with the stem cells showed indications of
beneficial clinical effects, such as "an improvement in breathing and swallowing
ability as well as in muscular power."
A month later, in February 2011, the U.S. Food and Drug Administration ("FDA")
granted Orphan Drug designation to NurOwn, the firm's autologous adult stem cell
product candidate for the treatment of ALS.
Last month, in June 2011, BrainStorm initiated a Phase I/II clinical trial for
the treatment of ALS with NurOwn at the Hadassah University Medical Center's in
Jerusalem, after receiving approval from the Israeli Ministry of Health ("MoH").
BrainStorm is the first company to receive clearance from the MoH to carry out a
differentiated stem-cell based therapeutic clinical trial in Israel. The
Company's production process for manufacturing clinical grade MSC-NTF cells is
in full compliance with Good Manufacturing Practice ("GMP") requirements.
The firm also recently announced that they had received the first installment of
a $1.3 Million NIS Grant from Israel's Office of the Chief Scientist (OCS).
With this much positive news, why weren't BCLI shares trading significantly
higher?
Actually. shares had begun to push higher on heavy volume recently, but some
investors got spooked after they realized that the firm was running low on cash
and had become overdue for a financing. Until that financing was in place, most
longs decided it was too risky to keep positions in the stock.
Now, this the raise out of the way, a key catalyst mentioned in the
BioMedReports FDA Calendar should be announced shortly and if the news is as
good as we think, this emerging firm which may well have the cure for ALS within
reach will make a mark.
According to published tracking data, BrainStorm is expected to announce interim
results for the first 12 patients from their initial phase study "by July
2012."-- as most recently announced (June 6, 2012). This key data may be
released within a couple of days, if not sooner.
Indeed, while Dr, Karussis may not be able to draw scientific conclusions or say
certain things in public statements, we have very good reason to believe that
upcoming clinical data will continue to show strong results. Especially if the
video report and earlier clinical trial results are any indication of what is
going on in Israel.
Any shares issued or released as part of the upcoming financing should be fully
registered "and locked up" for some time. Therefore, we anticipate that now that
the financing has been announced, this potential short-term trade is more "de-
risked" and ready to move higher. This is especially true given the significance
and upcoming unveiling of clinical data and that the warrants which were issued
to investors involved in the financing appear to be priced significantly higher.
Again, this stock could be set to gain traction now given all the fundamental
and technical indications are in play as we anticipated. As always, we urge you
to do your own due diligence.
A full report on BCLI containing additional links and graphics is now available
at: http://bit.ly/BCLIReport
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: BioMedReports via Thomson Reuters ONE
[HUG#1627413]
Datum: 17.07.2012 - 19:37 Uhr
Sprache: Deutsch
News-ID 166210
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