Pluristem Develops PLX-RAD Cells for Use in Hematology
May 07 2013 - 3:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, announced today that it
has identified its first clinical indication in the hematology
field for its Placental eXpanded (PLX) RAD cells for the
enhancement of the engraftment of Hematopoietic Stem Cells (HSC) in
patients experiencing a delay or failure of their bone marrow
transplant (BMT). This follows Pluristem's completion of additional
pre-clinical studies showing promising results for PLX-RAD for this
indication.
According to the National Marrow Donor Program, an estimated
25,000 allogeneic bone marrow transplants are performed annually
worldwide. Approximately 15% of these patients will either have a
delay or failure to engraft the HSCs, resulting in a condition that
is life threatening, expensive and often requires the continued
support of the patient with blood products. PLX-RAD may be
beneficial to these patients.
PLX-RAD is currently being evaluated by the U.S. National
Institute of Allergy and Infectious Diseases (NIAID), a division of
the U.S. National Institutes of Health, in models of the acute
radiation syndrome (ARS).
PLX-RAD, Pluristem's second product candidate, joins PLX-PAD
that is in clinical trials for the treatment of peripheral artery
disease, muscle injury and Pulmonary Hypertension. Both product
candidates are derived from placental raw material. The placenta is
a very rich source for a variety of cells and Pluristem
differentiates these products through the use of different cell
populations combined with its proprietary 3D bioreactor
manufacturing process that allows the company to change but
precisely control the environment in which the cells grow. This
results in a stable, consistent change to the therapeutic protein
secretion profile of the cell that constitutes the difference
between PLX-PAD and PLX-RAD. Pluristem intends to develop
additional PLX products by capitalizing on these unique competitive
advantages.
PLX-RAD cells have been shown to have an immunomodulatory effect
via the secretion of cytokines and proteins that are known to
stimulate Hematopoietic Stem Cells (HSC) to enhance the production
of white blood cells, red blood cells and platelets. There was also
evidence of a significant improvement in the recovery of these
three blood lineages in bone marrow deficient animals compared to
control animals.
Zami Aberman, Chairman and CEO stated, "We are very excited to
enter the field of hematology with our new PLX-RAD cell product
candidate. PLX-RAD's unique protein secretion profile enables its
use in bone marrow deficiency syndromes. This unique characteristic
will enable us to provide a product candidate that enables the
recovery of the three blood lineages, potentially positioning
PLX-RAD as first line treatment in a variety of bone marrow
deficiencies."
About Enhancing HSC Engraftment at
Pluristem
The essential element in BMT is the transplantation of
Hematopoietic Stem Cells (HSC), the precursor of the formed
elements of the blood (red cells, white cells and platelets). BMT
is commonly used in the treatment of hematological malignancies to
reconstitute the patient's bone marrow after their diseased marrow
is eradicated with chemo or radiotherapy. Approximately 15% of
patients undergoing BMT will either have a significant delay or
failure to engraft the HSCs contained in the BMT, a condition that
is life threatening, expensive and often requires the continued
support of the patient with blood products. After demonstrating a
significant enhancement of HSC engraftment in animals and in three
patients with BMT failure where PLX cells were administered under a
compassionate use program, the company established a Hematology
Clinical Advisory Board comprised of thought leaders in
hematology throughout the world.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of
placenta-based cell therapies. The Company's patented PLX
(PLacental eXpanded) cells are a drug delivery platform that
releases a cocktail of therapeutic proteins in response to a host
of local and systemic inflammatory and ischemic diseases. PLX cells
are grown using the company's proprietary 3D micro-environmental
technology and are an "off-the-shelf" product that requires no
tissue matching prior to administration.
Pluristem has a strong intellectual property position,
company-owned GMP certified manufacturing and research facilities,
strategic relationships with major research institutions and a
seasoned management team. For more information visit
www.pluristem.com, the content of which is not part of this press
release.
The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and federal securities
laws. For example, we are using forward-looking statements when we
discuss the use of our PLX-RAD cells in hematology and how our
PLX-RAD may be beneficial to certain patients, when we discuss our
intention to develop additional PLX products, when we discuss how
PLX-RAD's unique protein secretion profile will enable the use of
PLX-RAD for for bone marrow deficiencies or when we discuss how
this unique characteristic will enable us to provide a product
candidate that enables the recovery of the three blood lineages.
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 surgical 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: Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
1-303-883-4954
William.PratherMD@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com