Communicators

Pluristem Therapeutics Files an IND Application with the FDA to Initiate a Phase I Clinical Trial Utilizing PLX-PAD for Critical Limb Ischemia

NEW YORK – Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical trials with its placental-derived stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia.

Following clearance of the IND application by the FDA, Pluristem will initiate Phase I dose ranging clinical trials during the first half of 2009 at two clinical sites in the U.S.A. As in the clinical trials with PLX-PAD that are to begin in Europe (see press release dated December 16, 2008), the patients in the U.S. trials 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.

Zami Aberman, Chairman, President and CEO of Pluristem stated: "We are pleased to be filing this IND application in the U.S.A. Following approval by the FDA, we will begin administering PLX-PAD to patients afflicted with critical limb ischemia with the goal of proving this product safe”. Mr. Aberman went on to say that: "The IND application filed with the FDA and the IMPD application filed in Europe are two important steps in Pluristem's global strategy to become a dominant player in the cellular therapeutic business arena”.

Edwin M. Horwitz, MD, PhD, Director of Cell Therapy in the Division of Oncology / Blood & Marrow Transplantation at Children’s Hospital of Philadelphia, an internationally recognized authority on mesenchymal stromal cells, and the Chairman of Pluristem’s Scientific Advisory Board, stated: "This is an exciting time for Pluristem. Success in this endeavor will signify the first time an adult stem cell, derived from the placenta and grown using the Company's PluriX 3D technology, has been administered to humans safely. This will represent a major advance in cell therapy and position Pluristem as an international leader in the field”.

Brian Annex, MD, Chief of the Division of Cardiovascular Medicine, Department of Medicine at the University of Virginia School of Medicine and a member of Pluristem’s Scientific Advisory Board, stated: “If Pluristem’s clinical trial is successful, this will be a major advance in the field of cellular therapeutics with the use of an allogeneic off-the-shelf product that needs no matching for peripheral vascular disease and then, potentially, other diseases”.

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 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 Therapeutics

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic), off-the-shelf, 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 PluriX TM 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 critical limb ischemia (CLI), an end stage of peripheral artery disease (PAD). The Company's products in development also 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.

See our product animation on YouTube: http://www.youtube.com/watch?v=OFhWXyJT6Us

For more information visit our website at: http://www.pluristem.com, the content of which is not part of this press release.

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 state that we will initiate Phase I dose ranging clinical trials during the first half of 2009, or that we will begin administering PLX-PAD to patients afflicted with critical limb ischemia with the goal of proving this product safe, or that the IND application filed with the FDA and the IMPD application filed in Europe are two important steps in Pluristem's global strategy to become a dominant player in the cellular therapeutic business arena, 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: failure to obtain required regulatory approvals, changes in technology and market requirements; 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; 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 risk and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

William Prather RPh, MD
Sr. VP Corporate Development
Ph: 303-883-4954
bill@pluristem.com



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