New Data from ARS Study Shows Significant Hematological Deficiencies Even at Low Radiation Levels; PLX-R18 Supports Hematolog...
July 26 2017 - 1:00PM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today presented
new data at the RITN (Radiation Injury Treatment Network)
conference from a recent study evaluating PLX-R18 as a treatment
for Acute Radiation Syndrome (ARS).
Pluristem recently announced positive data from
a Phase II-equivalent study under the FDA Animal Rule demonstrating
improved survival and hematological recovery of non-human primates
(NHP) exposed to high levels of radiation. The study was conducted
and funded by the U.S. National Institute of Allergy and Infectious
Diseases (NIAID), part of the U.S. National Institutes of Health
(NIH).
New data from the study focuses on 12 additional
NHPs that were exposed to lower radiation levels than those in the
initial study. In a radioactive or nuclear incident, many victims
will suffer from health effects resulting from low radiation
exposure and not necessarily from the more dire impact of exposure
to high radiation levels. The findings suggest that even though low
radiation exposure is not lethal, it can lead to serious
hematological deficiencies and to long-term health problems that
result from such damage.
Neutrophil, lymphocyte, and platelet counts of
the 12 PLX-R18-treated subjects showed faster recovery than those
of the study’s control group. This finding indicates that PLX-R18
could potentially be used as a treatment for additional indications
relating to bone marrow deficiencies, such as those that may occur
due to radiotherapy, chemotherapy, adverse drug reaction and some
genetic conditions.
These new findings also strengthen the safety
profile of PLX-R18 in subjects exposed to different levels of
radiation and even to subjects not exposed to radiation at all.
This is a critical factor in case of disasters where screening of
victims for exposure levels would delay treatment and potentially
reduce its efficacy.
In addition, a thorough analysis of the initial
group of 24 NHPs exposed to high doses of ionizing radiation showed
that PLX-R18 treatment shortened the length of time spent below
severe blood count thresholds, thus avoiding serious infections,
hemorrhaging, and anemia.
“There is a crucial need for a therapy to
effectively treat populations in case of nuclear or radioactive
incidents. These positive results strengthen our confidence in the
safety profile and treatment potential of PLX-R18 for different
levels of radiation exposure. These new findings, showing
improvement in the hematologic system at lower radiation levels,
suggest that PLX-R18 has the potential to treat the broader
population exposed to different levels of radiation and might also
be used for additional indications such as mitigating the negative
effects of cancer treatments like chemotherapy,” said Yaky Yanay,
president and Co-CEO of Pluristem. “With the knowledge that
applications of PLX-R18 could go far beyond treating victims of
nuclear incidents, we are one step closer to fulfilling our goal of
providing better treatment options for millions of patients
worldwide.”
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.
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
that the findings of the PLX-R18 study indicate the potential for
PLX-R18 to be used as a treatment for additional indications and to
be effective in treating radiation exposure, as well as when we
discuss that the findings of the PLX-R18 study strengthen the
safety profile of PLX-R18 administered to subjects exposed to
different levels of radiation or even to subjects not exposed to
radiation at all. 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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