Healthcare Industry News:  peripheral artery disease 

Regenerative Medicine

 News Release - June 16, 2009

Pluristem Therapeutics Receives European Regulatory Approval for Placental-Derived Stem Cell Clinical Trial

Approval Paves Way for US and European Trials That Will Enroll Patients Diagnosed with Critical Limb Ischemia Who are Facing Amputation

HAIFA, Israel--(HSMN NewsFeed)--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 Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has approved the Company’s Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). In addition, Pluristem has already received approval from the Ethics Committee and, as previously announced, the US Food & Drug Administration (FDA) had cleared the Company’s Investigational New Drug (IND) application to initiate a similar trial in the United States. Both approvals of the CTA and IND clear the way for the world’s “first-in-man” clinical trial using PLX-PAD.

Pluristem’s placental-derived stem cells are expanded using the company’s proprietary 3D PluriX™ technology. PLX-PAD is an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients. In these phase I trials, to be conducted at multiple locations in the US and Germany, PLX-PAD will be administered to patients considered "late stage" that have not responded to traditional medical or surgical interventions.

Zami Aberman, Chairman, President and CEO of Pluristem stated: “Administering the first allogeneic stem cell product in Germany, Pluristem will be using PLX-PAD, our first product candidate in our cell therapy pipeline. Additionally, should the clinical trials in the US and Europe prove successful, it will have been the first time adult stem cells, derived from placenta and grown using our proprietary technology, have been administered to humans safely. Because our PLX cells are an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients, we believe this unique approach can provide patients with an affordable, immediate source of cell therapy. We believe all this positions Pluristem as a leader in the cell therapy field.”

Professor Doctor Hans-Dieter Volk, Chairman of Charité-Universitaetsmedizin Berlin, Institute of Medical Immunology, and Chairman of the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) stated: “Pluristem’s unique approach of implementing the placenta as the source for cell therapy can potentially be the key to future treatments that may help millions of patients. We at the BCRT believe that regenerative therapy using placental-derived cells has the potential to become the superior source for allogeneic cellular therapy.”

About Critical Limb Ischemia

In the US alone, it is estimated that 8-12 million people suffer from critical limb ischemia associated with 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 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 PluriXTM 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, 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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Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we discuss the launching or possible success of clinical trials, the safe administration of our product to humans, the ability of our approach to provide an affordable, immediate source of cell therapy, our potential leadership in the field, and the ability of our approach to help patients, we are using forward-looking statements. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

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Source: Pluristem Therapeutics

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