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Pluristem Certified as a Good Manufacturing Practices (GMP) Site for the
Manufacture of PLX cells for its Clinical Trials
Wednesday June 25, 10:00 am
ET
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NEW YORK--(BUSINESS WIRE)--Pluristem
Therapeutics Inc. (NASDAQ:PSTI
-
News); (DAX:PJT), a bio-therapeutics company
dedicated to the commercialization of
non-personalized (allogeneic) cell therapy
products for a variety of degenerative, ischemic
and autoimmune indications, today announced that
the Company has received certification that its
manufacturing facility in Haifa, Israel has been
approved as a Good Manufacturing Practices (GMP)
standard site for the purpose of manufacturing
PLX cells which will be shipped to the EU for
use in the Company’s
upcoming clinical trials. Pluristem was awarded
this certification by Biotec Distribution Wales,
Ltd., the designee of the Paul Ehrlich
Institute, the EU equivalent to the FDA, to
monitor the import, certification, labeling,
storage and distribution of PLX cells into the
EU for clinical trials. PLX cells are Pluristem’s
placental-derived mesenchymal stromal cells (MSCs)
that have been expanded in the Company’s
proprietary PluriX™
3-D bioreactor.
Mr. Zami Aberman, Pluristem's
President & CEO, stated: "Obtaining GMP approval
to manufacture our PLX cells for shipment into
the EU is a major step towards launching our
clinical trials in Europe. Our target is to
begin Phase I/II clinical trials for our first
product, PLX-PAD for the treatment of patients
with peripheral artery disease (PAD), during Q4
of this year."
About Pluristem
Pluristem Therapeutics Inc. is a
bio-therapeutics company dedicated to the
commercialization of non-personalized
(allogeneic) cell therapy products for the
treatment of several severe degenerative,
ischemic and autoimmune disorders. The Company
is developing a pipeline of products, stored
ready-to-use, that are derived from human
placenta, a non-controversial, non-embryonic,
adult stem cell source.
These placental mesenchymal
stromal cells (MSCs) are expanded in the
Company's proprietary PluriXTM
3D bioreactor, which imitates the natural
microstructure of bone marrow and does not
require supplemental growth factors or other
exogenous materials. Pluristem believes that the
resultant PLX (PLacental eXpanded) cells are
multi-potent and able to differentiate into a
variety of cell types. Recent evidence also
suggests their efficacy may be related to the
secretion of cytokines or other potent immune
modulators. Furthermore, PLX cells are immune
privileged and have immunomodulatory properties,
thus protecting the recipient from immunological
reactions that often accompany transplantations.
Pluristem's first product in
development, PLX-PAD, is intended to improve the
quality of life of millions of people suffering
from peripheral artery disease (PAD). The
Company's products in development also include
PLX-BMT, targeting the global shortfall of
matched tissue for bone marrow transplantation (BMT)
by improving the engraftment of hematopoietic
stem cells (HSCs) contained in umbilical cord
blood; PLX-STROKE, targeting ischemic stroke;
PLX-MS, targeting Multiple Sclerosis; and
PLX-IBD, targeting Inflammatory Bowel Disease (IBD),
which includes Crohn’s
disease and Ulcerative Colitis.
Pluristem has offices in the USA
with research and manufacturing facilities in
Israel.
See our product animation on
YouTube:
http://www.youtube.com/watch?v=OFhWXyJT6Us.
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, when we
say that our target is to begin Phase I/II
clinical trials for our first product, PLX-PAD
for the treatment of patients with peripheral
artery disease (PAD), during Q4 of this year, we
are using forward-looking statements. These
forward-looking statements 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;
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; results in the
laboratory may not translate to equally good
results in real surgical settings; 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
risk and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed
from time to time with the Securities and
Exchange Commission.
For more information visit our
website at
www.pluristem.com, the content of which is
not part of this press release.
Contact:
Pluristem Therapeutics Inc.
William Prather RPh, MD
Sr. VP Corporate Development
303-883-4954
bill@pluristem.com
Source: Pluristem Therapeutics Inc.
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