Pluristem and Indiana University to Initiate Joint Project Evaluating PLX-R18 in Acute Radiation Syndrome, Targeting Bridging...
April 23 2018 - 07:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a
leading developer of placenta-based cell therapy products,
announced today that the U.S. National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), has awarded a $2.5 million grant to Indiana
University to conduct studies of Pluristem’s PLX-R18 cell therapy
in the treatment of acute radiation syndrome (ARS).
The goal of this project is to extend the
PLX-R18 ARS studies to include examination of survival efficacy in
additional populations, such as geriatric and pediatric, and to
compare the effectiveness and examine interactions with other
drugs, such as Granulocyte-Colony Stimulating Factor (G-CSF). Data
collected during the first year of this 5-year research agreement
will support Pluristem’s Biologics License Application (BLA) filing
with the U.S. Food and Drug Administration (FDA) for marketing
approval of PLX-R18 in the treatment of ARS.
The $2.5 million, 5-year research collaboration
agreement will be performed in conjunction with Indiana University
researchers led by Prof. Christie M. Orschell. As part of this
agreement, Pluristem will be reimbursed for supplying PLX-R18 cells
for these studies.
Following previous positive results from a Phase
II-equivalent study in non-human primates, sponsored by NIAID,
Pluristem is now in discussions with the FDA and several U.S.
governmental agencies to clear the path and funding for a pivotal
study of PLX-R18 in the treatment of ARS.
“We are very pleased to receive NIH support
through this important grant to Indiana University for advancing
PLX-R18 towards becoming an approved countermeasure for ARS.
Pluristem looks forward to working with the researchers at Indiana
University who have broad expertise in this field of research,”
stated Pluristem Co-CEO and President Yaky Yanay. “We expect to
collect data from these studies to support the initiation of the
pivotal study protocol, an essential step in the PLX-R18 product
development.”
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 collaboration with Indiana University, allocation of
grants, reimbursement to Pluristem for supplying PLX-R18 cells for
the studies conducted with Indiana University, discussions with the
FDA and governmental agencies to clear the path and funding for a
pivotal study of PLX-R18, that data collected from the studies will
support the initiation of a pivotal study protocol and Pluristem’s
BLA with the FDA for marketing approval of PLX-R18. 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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