Pluristem and Fukushima University Report Positive Data: PLX-R18 Increases Survival Rates and Mitigates Severe Intestinal Dam...
June 25 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today reported
positive data from studies conducted in collaboration with
Fukushima Medical University evaluating PLX-R18 cells as a
treatment for radiation damage to the gastrointestinal (GI) tract
and bone marrow. Data from these studies showed that PLX-R18 cells
significantly increase survival rates, preserve GI stem cells
activity that enhance the recovery of the GI system and prevents
severe damage to the intestinal lining, suggesting PLX-R18
potential as a multi-organ therapy for acute radiation syndrome
(ARS).
Under a Memorandum of Understanding (MOU) with
Pluristem, Fukushima University, Fukushima Global Medical Science
Center, has been developing targeted animal models of ARS and has
been testing these models in studies to evaluate the efficacy of
PLX-R18 in treating radiation damage to the GI tract and bone
marrow of mice.
In these preclinical studies, data showed that
treatment with PLX-R18 following exposure to high level of ionizing
radiation (14 Gy) with partial shielding of the bone marrow, led to
a 50% increase in survival, significantly reduced weight loss and
increased white blood cell and platelet counts as compared to the
control groups. GI tract damage in ARS typically includes damage
to, or reduction of, local stem cells, as well as a breach of the
lining of the GI tract, leading to life threatening diarrhea and
sepsis. Histopathological analysis from these studies showed that
PLX-R18 cells mitigate severe damage to the intestinal lining,
preserve survival and enhance regeneration of local stem cells,
thus preventing breaches and support recovery of the GI tissue
following exposure to high levels of ionizing radiation.
Akihiro Inano, Ph.D. of Fukushima University
stated, “We were impressed by PLX-R18’s ability to increase
survival by mitigating the damage of high levels of radiation on
these organ systems. The development of this animal model enabled
us to evaluate the efficacy of treating ARS in both the GI system
and bone marrow simultaneously. Lethality in ARS originates mainly
from radiation-induced injuries to bone marrow and the GI tract,
highlighting the importance of the study’s purpose and results. We
are now conducting a more extensive analysis of the data and plan
to present these findings at the 18th World Congress of Basic and
Clinical Pharmacology at Kyoto, Japan (July 1-6, 2018).
Pluristem Chairman and Co-CEO Zami Aberman
commented, “We are very happy with the results and the expert
research done by Fukushima University. A 50% Increase in survival
is particularly impressive given the very high level of radiation
exposure in these subjects and the damages that follow such
radiation, especially to the bone marrow and the GI tract. The
findings show, for the first time, that PLX-R18 has the ability to
treat ARS as a multi-organ therapy. There is advancing scientific
understanding that ARS is a multi-organ system injury and needs to
be treated as such. We believe these findings position PLX-R18 as
the ultimate therapy available today for acute radiation
injuries.”
Pluristem’s PLX-R18 cells are in late-stage
development as a treatment for ARS in a program conducted and
funded by the U.S. National Institutes of Health (NIH) and are also
being studied by the U.S. Department of Defense (DOD) to support
the needs of the U.S. armed forces. PLX-R18 investigational new
drug (IND) application for ARS was recently cleared by the U.S.
Food and Drug Administration (FDA), allowing Pluristem to treat
victims who may have been acutely exposed to high dose radiation
due to nuclear attack or accident. Pluristem’s PLX-R18 ARS program
has also received an orphan drug designation by the FDA.
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 that PLX-R18 may have potential as a multi-organ therapy
for ARS and its belief that the study’s findings position PLX-R18
as the ultimate therapy available today for acute radiation
injuries. 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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