Pluristem Upgrades Manufacturing Facilities to Enable Production of First Biological Product for Phase I Clinical Trials
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.
SOURCE: Pluristem Life Systems, Inc.
CONTACT: Emerson Gerard Associates, Inc. Media Contact Jerry Jennings, 561-881-7318 mediareply@emersongerard.com
. |
