Pluristem Granted Key Patent in Japan for Treatment of GI Following Acute Radiation Exposure
July 26 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that the Japan Patent Office has granted Pluristem a patent for the
treatment of Acute Radiation Syndrome (ARS) and its impact on the
gastrointestinal tract. The patent titled “Methods for Treating
Radiation or Chemical Injury” relates to intramuscular (IM)
administration of adherent stromal cells, cultured under
three-dimensional culturing conditions, for mitigating intestinal
damage in patients that have been exposed to radiation or
chemotherapy.
“The patent is a particularly meaningful asset
for our Company in Japan, due to recently published findings from
pre-clinical studies conducted at Fukushima Medical University,
showing that following radiation exposure PLX-R18 cells
significantly increase survival rates, preserve GI stem cell
activity, enhance the recovery of the GI system and prevent severe
damage to the intestinal lining,” stated Pluristem Chairman and
Co-CEO Zami Aberman.
“We believe PLX-R18 is the optimal therapy
available today for acute radiation injury. ARS includes injury to
multiple organs, with its lethality stemming from radiation-induced
damage mainly to the bone marrow and GI tract. The Fukushima
University studies demonstrate PLX-R18’s potential ability to treat
multiple organs affected by ARS,” Aberman added.
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) and Fukushima
University. A 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. 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 treat multiple organs
affected by ARS. 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, 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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