BrainStorm Issues a Statement to Patients and Shareholders
February 19 2019 - 8:06AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, in response to numerous
requests, issues today the following statement:
We will begin by thanking the participants and
their families for participating in BCT-002. BrainStorm wishes to
express its sincere gratitude to all of you. Enrolling in the
trial is a brave and selfless act. You're making a difference
by offering a ray of hope for all people living with ALS.
Without you, we could not advance the clinical development of the
investigational therapy NurOwn®. You are all
heroes.
The BCT-002 double-blind placebo-controlled
phase 3 trial evaluating the efficacy and safety of repeated doses
of the investigational therapy NurOwn® is actively recruiting
eligible participants at all 6 U.S. sites. Since the trial is
double-blinded, Brainstorm, the participants and the study
researchers do not know who is receiving NurOwn treatment or
placebo. Therefore, in order to protect the integrity of the
trial and the clinical development program for the investigational
therapy NurOwn®, we cannot comment on any of the social media
postings by patients or the email requests we are
receiving.
Please note that based on the broad experience
in ALS clinical trials, one can expect that some study participants
may not respond to therapy and at the same time transient
improvements can be observed in some participants after receiving
placebo. Therefore, individual reports of improvement or lack of
improvement should be cautiously interpreted.
Brainstorm stays fully committed to advance our
pivotal phase 3 ALS trial towards a BLA submission. We
strongly believe that currently this is the best and most credible
pathway to demonstrate that NurOwn® may be a safe and an
effective treatment option for ALS patients. If the outcome of the
trial is successful, we hope to be able to bring a much-needed
solution to ALS patients as quickly as possible.
As stated publicly in June 2018, we have
faithfully followed through on our commitment to Matt Bellina to
provide treatment through the Right to Try pathway free of
charge. We confirm that the treatment has been initiated, and
since NurOwn® is still an “investigational therapy” we
refrain from any further comment.
In conclusion, BrainStorm remains dedicated to
rapidly advancing our pivotal phase 3 ALS trial and we appreciate
the support and encouragement of the ALS community.
About BrainStorm Cell Therapeutics,
Inc.
BrainStorm Cell Therapeutics Inc. is a leading
developer of innovative autologous adult stem cell therapeutics for
debilitating neurodegenerative diseases. The Company holds the
rights to clinical development and commercialization of the NurOwn®
technology platform used to produce autologous MSC-NTF cells
through an exclusive, worldwide licensing agreement. Autologous
MSC-NTF cells have received Orphan Drug status designation from the
U.S. Food and Drug Administration (U.S. FDA) and the European
Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a
Phase 3 pivotal trial in ALS (NCT03280056), investigating
repeat-administration of autologous MSC-NTF cells at six sites in
the U.S., supported by a grant from the California Institute for
Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is
intended to support a filing for U.S. FDA approval of autologous
MSC-NTF cells in ALS. For more information, visit BrainStorm's
website at www.brainstorm-cell.com.
Safe-Harbor
Statements
Statements in this announcement other than
historical data and information constitute "forward-looking
statements" and involve risks and uncertainties that could cause
BrainStorm Cell Therapeutics Inc.'s actual results to differ
materially from those stated or implied by such forward-looking
statements. Terms and phrases such as "may", "should", "would",
"could", "will", "expect", "likely", "believe", "plan", "estimate",
"predict", "potential", and similar terms and phrases are intended
to identify these forward-looking statements. The potential risks
and uncertainties include, without limitation, risks associated
with BrainStorm's limited operating history, history of losses;
minimal working capital, dependence on its license to Ramot's
technology; ability to adequately protect the technology;
dependence on key executives and on its scientific consultants;
ability to obtain required regulatory approvals; and other factors
detailed in BrainStorm's annual report on Form 10-K and quarterly
reports on Form 10-Q available at http://www.sec.gov. These factors
should be considered carefully, and readers should not place undue
reliance on BrainStorm's forward-looking statements. The
forward-looking statements contained in this press release are
based on the beliefs, expectations and opinions of management as of
the date of this press release. We do not assume any obligation to
update forward-looking statements to reflect actual results or
assumptions if circumstances or management's beliefs, expectations
or opinions should change, unless otherwise required by law.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity, performance or
achievements.
CONTACTS
Media:Joseph PetrozielloBrainStorm Cell
TherapeuticsPhone:
+1.215.485.6797Email: JP@brainstorm-cell.com
Investors:Marcy Beth NanusSolebury TroutPhone:
+1.646.378.2927Email: MNanus@troutgroup.com
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