Pluristem Therapeutics Announces Major Clinical Site in North Carolina for PLX-PAD Phase-I Trial
NEW YORK, May 05, 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 Duke University Medical Center, affiliated with Duke University, Durham, North Carolina, will serve as a clinical site for Pluristem's Phase-I clinical trial involving PLX-PAD for patients with critical limb ischemia (CLI).
Zami Aberman, Chairman, President and CEO of Pluristem stated: "We are very pleased to be working with Duke University Medical Center on the Phase-I clinical trial using our PLX cells and believe that being involved with such a prestigious, reputable institution emphasizes the important therapeutic future for our mesenchymal-like stem cells."
Duke Cardiologist Robert Mitchell MD, Associate in Medicine at Duke University Medical Center and the Principal Investigator for Pluristem's PLX-PAD trial, stated: "We look forward to collaborating with Pluristem in studying this interesting potential approach to dealing with limb ischemia. This is an oftentimes devastating disease and beginning the process of understanding the action of these cells in a Phase-I clinical trial is an important step forward."
About Pluristem's PLX-PAD Clinical Trials
Following clearance by the FDA of an Investigation New Drug (IND) application that was filed January 13, 2009, Pluristem will initiate Phase I dose ranging clinical trials during the first half of 2009 at Duke and one other clinical site in the U.S.A. As in the clinical trial with PLX-PAD that are to begin in Europe (see press release dated December 16, 2008), the patients in the U.S. trial will be considered "late stage" and defined as patients whose limb ischemia has not responded to traditional medical or surgical interventions and are facing amputation.
About CLI
In the US alone, it is estimated that 8-12 million people suffer from Critical Limb Ischemia (CLI) associated with Peripheral Artery Disease (PAD). The disease is characterized by narrowing and hardening of the arteries in the patient's limb(s) caused and/or aggravated by diabetes, Buerger's Disease, other diseases and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications. Industry experts have estimated that the market for therapeutics used in the treatment of limb ischemia to be over $1 Billion. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led the medical community to call for the development of cellular therapies, such as Pluristem's PLX-PAD, as alternative treatments.
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. 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 (PLX) 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.
Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), received FDA clearance to begin a "First-In-Human" placental-derived mesenchymanl-like stromal cell clinical trial.
The Company's additional product candidates include PLX-IBD, targeting Inflammatory Bowel Disease (IBD), 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 (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke. |
