Third Clinical Site Initiated for BrainStorm Cell Therapeutic’s Phase 2 Progressive MS Study
July 02 2019 - 8:15AM
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in
developing innovative autologous cellular therapies for highly
debilitating neurodegenerative diseases, announced today that the
Company has contracted with the Keck School of Medicine of The
University of Southern California and its academic medical center,
Keck Medicine of USC as the third clinical study site for the
Company’s Phase 2 open-label, multicenter study of repeated
intrathecal administration of autologous MSC-NTF cells in
participants with progressive Multiple Sclerosis (MS). The study
will be directed at USC by Daniel Pelletier, MD, Professor of
Neurology, Eric and Peggy Lieber Chair in Neurology, Vice Chair,
Vice Chair, Clinical Research, Department of Neurology; and
Division Chief, Neuro-Immunology and USC Multiple Sclerosis
Center.
“The BrainStorm team is pleased to have the
opportunity to advance our Phase 2 clinical study for progressive
MS at the USC Keck School of Medicine,” said Chaim Lebovits,
President and CEO of BrainStorm. “We look forward to collaborating
with Dr. Pelletier, an internationally renowned leader in the field
of Multiple Sclerosis research and his team. Our NurOwn®
technology is an innovative investigational therapy currently being
studied in Phase 3 for ALS and in Phase 2 for progressive MS
patients.”
About NurOwn®
NurOwn® (autologous MSC-NTF) cells represent a
promising investigational therapeutic approach to targeting disease
pathways important in neurodegenerative disorders. MSC-NTF cells
are produced from autologous, bone marrow-derived mesenchymal stem
cells (MSCs) that have been expanded and differentiated ex vivo.
MSCs are converted into MSC-NTF cells by growing them under
patented conditions that induce the cells to secrete high levels of
neurotrophic factors. Autologous MSC-NTF cells can effectively
deliver multiple NTFs and immunomodulatory cytokines directly to
the site of damage to elicit a desired biological effect and
ultimately slow or stabilize disease progression. BrainStorm is
currently conducting a Phase 3 pivotal trial of autologous MSC-NTF
cells for the treatment of amyotrophic lateral sclerosis (ALS).
BrainStorm also recently received U.S. FDA acceptance to initiate a
Phase 2 open-label multicenter trial in progressive MS and
enrollment began in March 2019.
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.
BRAINSTORM CONTACTS: Media: Sean Leous
Westwicke/ICR PR Phone: +1.646.677.1839
Email: sean.leous@icrinc.com
Investors: Michael Levitan Solebury Trout Phone: +1.646.378.2920
Email:mlevitan@soleburytrout.com
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