Pluristem Therapeutics Prepares for Placental-Derived Stem Cell Clinical Trial
Posted : Mon, 09 Mar 2009 13:14:21 GMT
NEW YORK - (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 Company has completed several key initiatives in preparation for the upcoming clinical trial in Germany using the Company's placental-derived stem cell product candidate, PLX-PAD. The initiatives included a real time check (dry run) of PLX-PAD preparation for injection, a proceeding performed at Pharmicell, which was overviewed by Pluristem's team. In addition, the process flow between Pluristem and Pharmicell and the procedures of cell delivery to the clinical sites, Charité – Universitätsmedizin Berlin and Franziskus-Krankenh
Following European preparations, the Company expects to sign agreements with the clinical sites in the US and to conduct the necessary steps in order to initiate the clinical studies in the US.
In this dose ranging trial, conducted at multiple locations, PLX-PAD will be administered to patients with Critical Limb Ischemia (CLI), the end stage of peripheral artery disease (PAD). The patients enrolled will be considered "late stage" and defined as patients afflicted with CLI that have not responded to traditional medical or surgical interventions. PLX-PAD is an off-the-shelf, one-size-fits all product that needs no tissue matching prior to being administered to patients.
Zami Aberman, Chairman, President and CEO of Pluristem, stated: "Since this will be the world's first clinical trial using our placental-derived stem cells, we wanted to be sure all of the principals involved with the storage, transportation, dispensing and administration of PLX-PAD were coordinated. We, therefore, conducted a real time test of all PLX-PAD preparation-
Last week, the Company announced that the US Food & Drug Administration (FDA) had cleared the Company's Investigational New Drug (IND) application to initiate a Phase I clinical trial for the treatment of CLI.
About Critical Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from critical limb ischemia associated with peripheral artery diseases (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, critical 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.
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, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriXTM 3D bioreactor, which imitates the natural 3D microenvironment of these cells and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells' efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and possess immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The US Food & Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to initiate a Phase I clinical trial for the treatment of Critical Limb Ischemia (CLI), the end stage PAD in the US. The Company's other products in development include PLX-IBD, targeting Inflammatory Bowel Disease (IBD); 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.
Pluristem has offices in the USA with research and manufacturing facilities in Israel.
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