U.S. Department of Defense to Conduct Studies of Pluristem’s PLX-R18 in a New ARS Project for Use Before Radiation Exposure...
August 16 2017 - 7:30AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
that a pilot study of the company’s PLX-R18 cell therapy will be
initiated by the U.S. Department of Defense’s (DOD) Armed Forces
Radiobiology Research Institute (AFRRI), part of the Uniformed
Services University of Health Sciences (USU). The study will
examine the effectiveness of PLX-R18 as a treatment for Acute
Radiation Syndrome (ARS) prior to, and within the first 24 hours of
exposure to radiation.
ARS results from exposure to high levels of
radiation, such as in the case of a nuclear accident or attack, and
can lead to severe health consequences including death. Pluristem
recently reported positive data from studies of PLX-R18 cells as a
treatment for ARS conducted by the National Institute of Allergy
and Infectious Diseases (NIAID) at the National Institutes of
Health (NIH), U.S. Department of Health and Human Services (DHHS).
Data demonstrated improvement in survival rates and enhancement of
blood lineages recovery.
A key difference in the NIAID study and the
upcoming DOD study is the timeframe of exposure that is being
examined: in the NIAID study, PLX-R18 was administered to subjects
24 hours post exposure, while the new DOD study will be designed to
support the needs of the U.S. Armed Forces and examine subjects
receiving treatment prior to, or within the first 24 hours of
radiation exposure. The DOD studies will be conducted in parallel
with the NIH/DHHS studies, allowing broader understanding of the
potential therapeutic effects of PLX-R18 as a novel medical
countermeasure for ARS.
The study will be conducted in accordance with
the FDA Animal Rule pathway, the regulatory pathway followed when
human efficacy trials are not feasible, in this case due to the
ethics of exposing humans to nuclear radiation. Product approval
via this pathway is granted following large animal efficacy studies
and human safety data.
“We are pleased to see increased interest from
U.S. governmental agencies in our PLX-R18 cell therapy,” noted Zami
Aberman, Chairman and Co-CEO of Pluristem. “In view of the
therapeutic effects of our product and the current geopolitical
situation, governments can potentially shield their citizens from
the dire health effects arising from exposure to nuclear radiation,
saving many lives in the process, which is our ultimate goal.”
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. The cell products release a range of
therapeutic proteins in response to inflammation, ischemia,
hematological disorders, and radiation damage. PLX cell products
are grown using the Company's proprietary three-dimensional
expansion technology. They are off-the-shelf, requiring no tissue
matching prior to administration.
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.
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 received FDA
clearance to initiate a U.S. Phase I trial of PLX-R18 in incomplete
bone marrow recovery following hematopoietic cell transplantation.
Preclinical data from trials conducted by the NIH, Hadassah Medical
Center, 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 ARS
Acute Radiation Syndrome occurs following acute
exposure to very high levels of radiation, and involves severe,
potentially lethal injury to the bone marrow as well as to other
organs and systems within the body. High doses of radiation can
destroy the bone marrow’s ability to produce white cells, red cells
and platelets; without these cells patients are at high risk of
death.
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, we are using forward-looking statements when we discuss
how the proposed DOD study will be conducted and the various phases
of the study, as well as when we discuss that governments can
potentially shield their citizens from the dire health effects
arising from exposure to nuclear radiation, saving many lives in
the process, while using our products. 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; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our
products may not be approved by regulatory agencies, our technology
may not be validated as we progress further and our methods may not
be accepted by the scientific community; we may be unable to retain
or attract key employees whose knowledge is essential to the
development of our products; unforeseen scientific difficulties may
develop with our process; our products may wind up being more
expensive than we anticipate; 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; our patents may not be sufficient; our
products may harm recipients; changes in legislation; 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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