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NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics, Inc.
(NASDAQ:PSTI -
News) announced today
that it has filed a Pre-Investigational New Drug (Pre-IND) application
with the Paul Ehrlich Institute (PEI) in Germany for PLX-PAD, the
Company’s product for the treatment of
Peripheral Artery Disease. The PEI is the German federal authority
granting clinical trial approvals. PLX-PAD are mesenchymal stromal cells
(MSCs) obtained from the placenta and expanded using Pluristem’s
proprietary 3D PluriX™ technology.
Pluristem has submitted a scientific package to the PEI.
The package contains the results of a proof of concept study and
preclinical study synopses utilizing PLX-PAD to support an IMPD (Investigational
Medicinal Product Dossier) submission planned for later this year. This
Pre-IND document also contains information concerning the process used
to manufacture Pluristem’s PLX-PAD product
and the proposed clinical trial supporting the Company’s
IMPD.
Zami Aberman, Pluristem’s
President & CEO, stated: “I am proud that our
team has accomplished this important milestone in submitting this
Pre-IND document as planned. I believe it represents the Pluristem team’s
ability and devotion to successfully meet the Company’s
goal of building a pipeline of PLX products, leading the Company to
future achievements and prosperity."
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 the human placenta, a non-controversial source, and not from
embryonic stem cells.
The placental cells are expanded in the Company’s
proprietary PluriX™ 3D bioreactor, which
imitates the natural microstructure of bone marrow and does not require
supplemental growth factors, or other exogenous materials. Pluristem
believes 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 their secretion of
cytokines or other potent immune modulators. Furthermore, the PLX cells
are immune-privileged and immunosuppressive, hence protecting the
recipient from immunological reactions that often accompany
transplantations.
Pluristem’s PLX-PAD is
intended to improve the quality of life of millions of people suffering
from peripheral artery disease (PAD). Pluristem has previously announced
its PLX cells can be therapeutically beneficial in the treatment of a
variety of other indications, such as ischemic stroke and Parkinson’s
disease (PD).
The Company’s PLX-BMT is
intended to resolve 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 (UCB).
Pluristem has offices in the USA with research and
manufacturing facilities in Israel.
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.
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. For
example, when we discuss our team ability to successfully meet the
Company’s goal of building a pipeline of PLX
products, leading the Company to future achievements and prosperity, we
are using a forward looking statement. 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:
Source: Pluristem
Therapeutics, Inc.
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