| NEW YORK--(BUSINESS WIRE)--Pluristem Life Systems, Inc. (OTCBB:PLRS
- News), a cell
therapy company dedicated to the commercialization of non personalized
stem cell products for a variety of indications, today announced that
the United States Food and Drug Administration's (FDA) Center for
Biological Evaluation and Research (CBER) accepted the Company's
proposed Pre-Investigation New Drug (PreIND) for its PLX-BMT product in
pre-clinical studies for the treatment of hematological malignancies.
PLX-BMT is an innovative adjuvant cell therapy product based on PLacenta
eXpanded Mesenchymal cells. PLX- I is expected to be used to improve the
engraftment of Umbilical Cord Blood when treating blood cancer and blood
disorders. Acceptance of the Pre-IND document by the FDA precedes
initiation of Phase I trials.
Zami Aberman, CEO of Pluristem, stated, "We are pleased to receive
FDA's acceptance of our proposed pre-clinical studies, which may then
pave the way for initiating human clinical trials during 2007. The
meeting results prove the ability of our team to meet its target
milestones. We are enthusiastic about the potential of our placental
derived MSCs to become a superior alternative to bone marrow
transplantation. We designed PLX-BMT to improve umbilical cord blood (UCB)
engraftment, which if successful could be the key to resolving the
global shortage of bone marrow tissue matching for transplantation."
We believe that our placental derived Mesenchymal Stems Cells (MSCs),
which are expanded using the Company's unique PluriX technology, may be
useful for disorders other than hematological malignancies. Recently we
announced that our research provided evidence that PLX cells are "immune
privileged," which means they are invisible to a transplant recipient's
immune system and do not trigger rejection enabling the use of PLX cells
to treat other disorders."
About Pluristem
Pluristem Life Systems, Inc. is life sciences driven company that is
developing and commercializing of non personalized stem cell expansion
technology products for the potential treatment of a variety of
disorders. The Company is discovering and developing cell-based
therapeutics that utilizes adult stem cells expanded in a
three-dimensional proprietary bioreactor mimicking different naturally
occurring physiological environments. Pluristem expects its first
products to be cell grafts that will provide an efficient and superior
alternative to the standard procedure of bone marrow transplantation.
PLX-BMT, its first adult stem cell product, is intended to target a
critical global shortfall of matched tissue for bone marrow
transplantation since bone marrow transplantation is often the only cure
for patients suffering from leukemia, lymphoma, myeloma and many other
hematological diseases. The Company has made a strategic decision to
work only with adult stem cells since the practical use of embryonic
stem cells is severely restricted by various religious, ethical and
legal considerations.
For more information, please visit our website:
www.pluristem.com.
Safe Harbor Statement
This press release contains
statements, which may constitute "forward-looking statements" regarding
our intent, belief or current expectations. Forward-looking statements
in this release include that FDA's acceptance of our proposed
pre-clinical studies may pave the way for initiating human clinical
trials during 2007; that our placental derived MSCs have the potential
to become a superior alternative to bone marrow transplantation; that
our first products will be cell grafts that will provide an efficient
and superior alternative to the standard procedure of bone marrow
transplantation; that PLX-BMT could be the key to resolving the global
shortage of bone marrow tissue matching for transplantation; that our
unique PluriX technology may be useful for disorders other than
hematological malignancies. Factors which may prevent these forward
looking statements from coming to fruition include that our technology
may not be validated as we progress further; 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 to
protect essential aspects of our technology; competitors may invent
better technology; our products may not work as well as hoped or worse,
our products may harm recipients; and we may not be able raise funds for
development or working capital when we require it. As well, our products
may never develop into useful products and even if they do, they may not
be approved for sale to the public. For further risk factors see the
Company's latest 10-KSB filed with the SEC.
For more information visit our website at
www.pluristem.com |