| HAIFA, Israel--(BUSINESS WIRE)--Pluristem Life Systems, Inc. (OTCBB:
PLRS - News) announces they have completed upgrading and restructuring
their manufacturing facilities to enable the production of their first
biological product PLX-BMT for Phase I clinical trials. The manufacturing
facilities include thirteen units of 7000 square feet total and include
five clean room units of 3000 square feet total. Upon FDA approval, the
facilities could support production and shipping of up to 50 doses of
PLX-BMT per day worth more than $500,000. Zami Aberman, Pluristem CEO
states, "PLX-BMT can be used for the treatment of blood disorders and it
could also be helpful in additional clinical indications like autoimmune
disorders or cardiovascular diseases. It is a very valuable product and
we have made a strategic decision to control the production in-house.
Handling the product ourselves gives us a distinct advantage when these
cross application situations arise. And we have further determined that
to assist us in successful Phase I clinical trials and the ultimate
approval by the FDA, we have upgraded and restructured as a GMP
Compliance facility. GMP Compliance is a set of regulations set forth by
the FDA to help ensure that various products for human use are safe and
effective. GMP regulations address sanitation, process validation,
equipment and document traceability, and personnel qualification. We are
also working to become completely GMP compliant to further assure the
future successful production and market acceptance of PLX-BMT."
About Pluristem
Pluristem Life Systems, Inc. is a life sciences driven company that is
developing and commercializing stem cell expansion technology products
for the treatment of severe blood disorders. The Company is discovering
and developing cell-based therapeutics that utilizes adult stem cells
expanded in a 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.
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.
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
statements: that our facilities enable the production of the first
biological product PLX-BMT for Phase I clinical trials; that our
facilities could support production and shipping of up to 50 doses of
PLX-BMT per day worth more than $500,000 per day, that
PLX-BMT can be used for the treatment of blood disorders and it could also
be helpful in additional clinical indications like autoimmune disorders
or cardiovascular diseases, that we intend to control the production
ourselves; that our production will give us a distinct advantage; that
we are working to become completely GMP compliant; that we expect our
first products to be cell grafts that will provide an efficient and
superior alternative to the standard procedure of bone marrow
transplantation, and our first adult stem cell product is intended to
target a critical global shortfall of matched tissue for bone marrow
transplantation. Factors which may significantly change or prevent our
forward looking statements from fruition include that we may be unable
to attain GMP compliance; our facilities may not be capable of
controlling production; we may not receive any orders for our products;
we may be unsuccessful in developing any products; that our technology
may not be validated as we progress further and our methods may not be
accepted by the scientific community; that we are unable to retain or
attract key employees whose knowledge is essential to the development of
our products; that unforeseen scientific difficulties develop with our
process; that results in the laboratory do not translate to equally good
results in real surgical settings; that our patents are not sufficient
to protect essential aspects of our technology; that competitors may
invent better technology; that our products may not work as well as
hoped or worse, that our products may harm recipients; and that 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. |
