Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (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's PLacental eXpanded (PLX-MS) cells have
demonstrated in vivo efficacy in the prevention of Multiple Sclerosis (MS). PLX
cells are Pluristem's placental-derived mesenchymal stromal cells (MSCs) that
have been expanded in the Company's proprietary PluriX™ 3-D bioreactor.
In a further analysis aiming to demonstrate the in vivo efficacy of
PLX-MS cells for the prevention of MS, Experimental Autoimmune Encephalitis
(EAE) was induced in mice via immunization with the MOG35-55 protein on day 0.
EAE is an autoimmune inflammatory disease of the CNS that represents the
paradigmatic model for MS. The animals then received, on day 8, intravenously
either PLX-MS or PlasmaLyte, which served as a control. PLX-MS administration
prevented the appearance of clinical symptoms and signs associated with MS
throughout the 35-day study period compared to those animals receiving the
control. Additionally, the beneficial effects were similar to when Zappia et.
al. used MSCs that were non-placental in origin in this EAE animal model†.
Mr. Zami Aberman, Pluristem's President and CEO, commented: "This
trial's remarkable results demonstrated our PLX-MS cells' ability to prevent the
appearance of multiple sclerosis symptoms and showed the potential for our PLX
cells to treat global autoimmune diseases. As a cellular therapy, our PLX cells,
which are derived from human placenta, a non-controversial, non-embryonic, adult
stem cell source, and stored ready-to-use, could prove to be a readily available
preventive therapeutic alternative for these disorders."
initiating repeated sets of EAE experiments at the Berlin-Brandenburg Center for
Regenerative Therapy (BCRT) at Charité - University Medicine Berlin, one of the
largest independent clinical research centers in Europe.
†Mesenchymal stem cells ameliorate experimental autoimmune
encephalitis inducing T cell anergy.
Zappia et. al.
2005;106: 1755-1761 About Multiple Sclerosis (MS)
Multiple sclerosis (MS), also known as disseminated sclerosis or
encephalomyelitis disseminate, is an autoimmune condition in which the immune
system attacks the central nervous system (CNS), leading to demyelination.
Myelin is the insulating sheath that surrounds nerve cells (neurons). MS may
cause numerous physical and mental symptoms, and often progresses to physical
and cognitive disability. The World Health Organization (WHO) estimates that
over 2.5 million people globally suffer from MS, which represents a current
market of approximately $5.4 billion for disease-modifying agents to treat the
disorder. 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
Pluristem has offices in the USA with research and
manufacturing facilities in Israel.
See our product animation on YouTube.Safe Harbor Statement
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 the trial's remarkable
results demonstrated our PLX-MS cells' ability to prevent the appearance of
multiple sclerosis symptoms and showed the potential for our PLX cells to treat
global autoimmune disease, or that as a cellular therapy, our PLX cells could
prove to be a readily available preventive therapeutic alternative for these
disorders, 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. http://www.pluristem.comMS Society