Pluristem’s PLX-R18 Improves Hematopoietic Transplantation as Reported in Scientific Journal Frontiers in Medicine
February 27 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that Frontiers in Medicine has published key findings from a study
of PLX-R18 that demonstrate the cells’ efficacy in improving human
hematopoietic engraftment. The article titled, “Posttransplant
Intramuscular Injection of PLX-R18 Mesenchymal-Like Adherent
Stromal Cells Improves Human Hematopoietic Engraftment in A Murine
Transplant Model” was published in the peer-reviewed journal’s
February 2018 issue.
In the published study, mice were injected
intramuscularly (IM) with PLX-R18 following human hematopoietic
cell transplantation (HCT). Significant improvement was observed in
the peripheral blood counts as measured by CD45+ cell recovery at
weeks 6 (8.4 vs. 24.1%, p < 0.001) and 8 (7.3 vs. 13.1%, p <
0.05) and in the bone marrow at week 8 (28 vs. 40.0%, p < 0.01)
in the PLX-R18 treated groups versus the control, placebo groups.
Superiority of PLX-R18 treatment over the control groups was also
reported for recovery of CD19+ cells at weeks 6 (12.6 vs. 3.8%) and
8 (10.1 vs. 4.1%). These findings support Pluristem’s clinical
development of PLX-R18 for a variety of hematological
indications.
Pluristem is currently conducting a Phase I
clinical trial in the U.S. and Israel of PLX-R18 to treat
incomplete hematopoietic recovery following HCT. HCT is used to
treat bone marrow failure associated with cancers of the blood
and/or chemotherapy. When HCT fails to fully engraft, it poses
dangers to the patient. The Phase I study is evaluating the safety
of IM injections of PLX-R18 cells in 24 people with incomplete
hematopoietic recovery persisting for at least 4 months following
HCT.
Prof. Hillard M. Lazarus, Department of
Medicine, Case Western Reserve University, co-author of the
article, and Principal Investigator of Pluristem’s Phase I study of
PLX-R18 in HCT recovery, commented: “The published preclinical
study directly supports the current Phase I study of PLX-R18 in
HCT. The preclinical data clearly suggest that PLX-R18 may have a
therapeutic role in improving incomplete engraftment following HCT.
We hypothesize that PLX-R18 cells’ secreted proteins, cytokines and
chemokines are stimulating the marrow microenvironment, leading to
improved reproduction of the progenitor cells and increasing
peripheral blood counts.”
“Through the publication of this study, we are
pleased to add to the growing body of knowledge and data on PLX-R18
cells’ role following IM injection to improve hematopoietic cell
engraftment. These data support not only our Phase I study of
PLX-R18 in HCT, but may also support current and potential studies
of PLX-R18 in a broad range of hematologic indications,” stated
Pluristem Chairman and Co-CEO Zami Aberman.
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 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 its Phase I clinical trial of PLX-R18 generally as well
as when it states that PLX-R18 may have a therapeutic role in
improving incomplete engraftment following HCT or that the data
from its Phase I clinical trial of PLX-R18 to treat incomplete
hematopoietic recovery following HCT may support current and
potential studies of PLX-R18 in a broad range of hematologic
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, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
Efrat KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
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