Pluristem Therapeutics Announces First Patient Enrollment in Phase I Clinical Trial for Treatment of Peripheral Artery Disease With PLX-PAD
HAIFA, Israel, Jul 07, 2009 (BUSINESS WIRE) -- Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the first patient has been enrolled in a Phase I clinical trial of the Company's allogeneic placental-derived adherent stromal cell product, termed PLX-PAD. PLX-PAD is being used in patients afflicted with critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The first patient was enrolled at the Franziskus-Krankenhaus Hospital, Berlin. The initiation of this study follows the recent approval of the Company's Clinical Trial Application (CTA) to begin clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI), the German competent authority in the European Union. The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to fifteen adults with the disease will be included in the trial which is being conducted at the Franziskus-Krankenhaus Hospital and Charite - Universitatsmedizin Hospital, Berlin.
Zami Aberman, Chairman, President and CEO of Pluristem stated, "We are proud to begin clinical trials with PLX-PAD, a cellular therapeutic product derived from the placenta, the organ intimately involved in the miracle of birth and a ubiquitous source of adult stromal cells that are easily obtained without harm to the mother or baby. Additionally, our proprietary three-dimensional mass manufacturing technology allows us to grow cells significantly more efficiently and cost-effectively than cells grown via the labor intensive two-dimensional method which is the industry norm."
About Pluristem
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), a "First-In-Human" placental-derived mesenchymanl-like stromal cell product, has received FDA and IMPD clearance and is being investigated in a Phase I clinical trial. The Company is developing a pipeline of products derived from human placenta, a non-controversial, non-embryonic, adult stem cell source. The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use, and require no histocompatibility matching.
These placental adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriX(TM) 3D bioreactor system, which provides a 3D microenvironment that enables large-scale growth of these cells without the need for supplemental growth factors or other exogenous materials. PLX cells are immune privileged, possess immunomodulatory properties, and are expanded in vitro without showing signs of phenotypic or karyotypic changes. Pluristem believes that the PLX cells' mechanism of action may be related to the secretion of cytokines and/or other potent immune modulators.
The Company's additional product candidates include PLX-IBD, targeting Inflammatory Bowel Disease, which includes Crohn's disease and Ulcerative Colitis; PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
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