Updated:2007-02-08 06:07:52
Pluristem Announces US FDA Acceptance of its Pre-IND Application to begin Pre-clinical Studies using PLX- I in Hematological Malignancies
BUSINESS WIRE
NEW YORK--(BUSINESS WIRE)----Pluristem Life Systems, Inc. (OTCBB:PLRS), 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-I product in pre-clinical studies for the treatment of hematological malignancies.
PLX-I 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-I 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-I, 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. |
