U.S. Department of Defense to Study Pluristem’s PLX-R18 for the Treatment of Mustard Gas Injuries
June 19 2018 - 07:00AM
Studies to be funded by the U.S.
NIHMarks the second project for DOD with PLX-R18
cell therapy product
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a
leading developer of placenta-based cell therapy products,
announced today it has entered into an additional collaboration
agreement with the U.S. Department of Defense (DOD) and its United
States Army Medical Research Institute of Chemical Defense
(USAMRICD) to study the Company’s PLX-R18 cell therapy product in
the treatment of long term lung injuries following exposure to
mustard gas. These studies will be funded by the U.S. National
Institutes of Health (NIH) and mark the second project selected by
the DOD for PLX-R18. The DOD is also studying the effectiveness of
PLX-R18 as a novel medical countermeasure for Acute Radiation
Syndrome (ARS) prior to exposure to high levels of radiation,
designed to support the needs of the U.S. Armed Forces. These two
DOD projects are in addition to the NIH-funded late stage
development of PLX-R18 to treat the injuries from acute exposure to
high levels of radiation.
Sulfur mustard, also known as mustard gas, is a
chemical warfare agent, causing severe chemical burns in multiple
organs and can also lead to long term damage to the lungs.
Currently, supportive care is the only treatment available for
people exposed to mustard gas and there is no antidote
available.
In multiple studies conducted by several agencies,
including the NIH, PLX-R18 has been shown to be effective in
recovering the bone marrow, leading to regeneration of progenitor
cells and the three blood lineages, including white blood cells,
red blood cells and platelets. We believe that these data, together
with the results from additional studies conducted with PLX-R18 on
lung fibrosis, demonstrate the cells’ potential to counteract
injuries from sulfur mustard gas.
“Mustard gas injuries have both acute and long-term
consequences. We believe that PLX-R18 has the potential to
alleviate or prevent the devastating effects of both the acute and
chronic injuries following mustard gas exposure,” stated Pluristem
Co-CEO and President, Yaky Yanay. “Mustard gas is also known as a
radio-mimetic agent, with injuries similar to those appearing
following exposure to ionizing radiation. Following the positive
results with PLX-R18 in ARS we believe that the cells have the
potential to mitigate the deleterious effects of mustard gas.
Positive results from these studies may establish PLX-R18 as a
medical countermeasure against a wide range of chemical,
biological, radiological and nuclear (CBRN) threat agents.”
The DOD is already studying the effectiveness of
PLX-R18 as a novel medical countermeasure for Acute Radiation
Syndrome (ARS) prior to exposure to high levels of radiation,
designed to support the needs of the U.S. Armed Forces.
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 PLX-R18 cells’ potential to counter injuries and
deleterious effects from sulfur mustard gas and its belief that
positive results from these studies may establish PLX-R18 as a
medical countermeasure against a wide range of chemical,
biological, radiological and nuclear threat agents. 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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