Pluristem to Present Data on PLX-R18 in Treatment of Acute Radiation Syndrome at American Society of Hematology’s Annual Me...
December 07 2017 - 5:08AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a
leading developer of placenta-based cell therapy products,
announced today the company will present data from its Phase
II-equivalent study of PLX-R18 cells for the treatment of acute
radiation syndrome (ARS) at the American Society of Hematology’s
(ASH) 59th Annual Meeting to be held in Atlanta, Georgia, on
December 9-12, 2017.
The results of the study will be presented
during Program Session 506: Hematopoiesis and Stem Cells:
Microenvironment, Cell Adhesion, and Stromal Stem Cells. The
poster, “Intramuscular Administration of Placenta-Derived Stromal
Cells Enhances Survival of Rhesus Macaque Monkeys Exposed to Total
Body Irradiation,” will describe data from a recently announced
Phase II-equivalent study under the U.S. Food and Drug
Administration (FDA) Animal Rule. The data demonstrate improved
survival and hematological recovery of NHPs exposed to different
levels of radiation. This study was conducted and funded by the
U.S. National Institute of Allergy and Infectious Diseases (NIAID),
part of the NIH. The poster abstract will be published online in
the supplemental volume of Blood, a peer-reviewed medical journal
published by ASH.
“We are excited to present these promising data
on our PLX-R18 cells in the treatment of ARS to the world’s thought
leaders in hematology at this year’s ASH conference,” said Yaky
Yanay, president and Co-CEO of Pluristem. “We believe that there is
a crucial need for a therapy capable of effectively treating
populations in case of nuclear or radioactive incidents. These
findings, which show recovery of the hematologic system, suggest
that PLX-R18 has the potential to treat a large population exposed
to different levels of radiation and might also be used for
additional hematologic indications.”
About PLX-R18
PLX-R18 is Pluristem’s second cell therapy
product in development. It is designed to treat bone marrow that is
unable to produce enough blood cells due to a variety of causes
including ARS, certain cancers or cancer treatments, or
immune-mediated bone marrow failure. Pluristem is currently
enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete
bone marrow recovery following hematopoietic cell transplantation.
PLX-R18’s first animal studies in ARS were performed in
collaboration with Prof. Gorodetsky at Hadassah Medical Center.
Further preclinical data from trials conducted by the U.S. National
Institutes of Health, Hadassah, the Charite in Berlin and other
prominent research institutions, have shown that PLX-R18 cells
secrete a range of specific proteins that trigger the regeneration
of bone marrow hematopoietic cells, thereby supporting the recovery
of blood cell production. With its capabilities, PLX-R18 could
potentially treat a broad range of hematologic indications, which
together constitute a substantial global market.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
developer of placenta-based cell therapy products. The Company has
reported robust clinical trial data in multiple indications for its
patented PLX (PLacental eXpanded) cells, and is entering late-stage
trials in several indications. Our PLX cell products release a
range of therapeutic proteins in response to inflammation,
ischemia, muscle trauma, hematological disorders, and radiation
damage. The cells are grown using the Company's proprietary
three-dimensional expansion technology and can be administered to
patients off-the-shelf, without tissue matching. Pluristem has a
strong intellectual property position; Company-owned and operated,
GMP-certified manufacturing and research facilities; strategic
relationships with major research institutions; and a seasoned
management team.
Safe Harbor Statement
This press release contains express or implied
forward-looking statements within the Private Securities Litigation
Reform Act of 1995 and other U.S. Federal securities laws. For
example, Pluristem is using forward-looking statements when its
discusses that PLX-R18 has the potential to treat a large
population exposed to different levels of radiation and might also
be used for additional hematologic indications, and the potential
market for such indications. These forward-looking statements and
their implications are based on the current expectations of the
management of Pluristem only, and are subject to a number of
factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to
differ materially from those described in the forward-looking
statements: changes in technology and market requirements;
Pluristem may encounter delays or obstacles in launching and/or
successfully completing its clinical trials; Pluristem’s products
may not be approved by regulatory agencies, Pluristem’s technology
may not be validated as it progresses further and its methods may
not be accepted by the scientific community; Pluristem may be
unable to retain or attract key employees whose knowledge is
essential to the development of its products; unforeseen scientific
difficulties may develop with Pluristem’s process; Pluristem’s
products may wind up being more expensive than it anticipates;
results in the laboratory may not translate to equally good results
in real clinical settings; results of preclinical studies may not
correlate with the results of human clinical trials; Pluristem’s
patents may not be sufficient; Pluristem’s products may harm
recipients; changes in legislation may adversely impact Pluristem;
inability to timely develop and introduce new technologies,
products and applications; loss of market share and pressure on
pricing resulting from competition, which could cause the actual
results or performance of Pluristem to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Pluristem undertakes no obligation to
publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. For a more detailed
description of the risks and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time
with the Securities and Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North
America 1-914-512-4109
karinek@pluristem.com
Efrat Kaduri Head of Investor and Public
Relations 972-74-7108600 efratk@pluristem.com
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