NEWS OUT!!!
Pluristem Upgrades Manufacturing Facilities to Enable Production of First Biological Product for Phase I Clinical Trials
Business Wire - October 18, 2006 07:30
HAIFA, Israel, Oct 18, 2006 (BUSINESS WIRE) -- Pluristem Life Systems, Inc. (OTCBB: PLRS) announces they have completed upgrading and restructuring their manufacturing facilities to enable the production of their first biological product PLX-I 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-I per day worth more than $500,000.
Zami Aberman, Pluristem CEO states, "PLX-I 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-I."
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-I for Phase I clinical trials; that our facilities could support production and shipping of up to 50 doses of PLX-I per day worth more than $500,000 per day, that
PLX-I 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.
SOURCE: Pluristem Life Systems, Inc.
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