Healthcare Industry News:  peripheral artery disease 

Regenerative Medicine Regulatory

 News Release - March 4, 2008

Pluristem Submits Pre-IND Application in Germany to Initiate Clinical Trials of PLX-PAD for Peripheral Artery Disease

NEW YORK--(HSMN NewsFeed)--Pluristem Therapeutics, Inc. (NASDAQ:PSTI ) announced today that it has filed a Pre-Investigational New Drug (Pre-IND) application with the Paul Ehrlich Institute (PEI) in Germany for PLX-PAD, the Company’s product for the treatment of peripheral artery disease. The PEI is the German federal authority granting clinical trial approvals. PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX™ technology.

Pluristem has submitted a scientific package to the PEI. The package contains the results of a proof of concept study and preclinical study synopses utilizing PLX-PAD to support an IMPD (Investigational Medicinal Product Dossier) submission planned for later this year. This Pre-IND document also contains information concerning the process used to manufacture Pluristem’s PLX-PAD product and the proposed clinical trial supporting the Company’s IMPD.

Zami Aberman, Pluristem’s President & CEO, stated: “I am proud that our team has accomplished this important milestone in submitting this Pre-IND document as planned. I believe it represents the Pluristem team’s ability and devotion to successfully meet the Company’s goal of building a pipeline of PLX products, leading the Company to future achievements and prosperity."

About Pluristem

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (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 the human placenta, a non-controversial source, and not from embryonic stem cells.

The placental cells are expanded in the Company’s proprietary PluriX™ 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors, or other exogenous materials. Pluristem believes the resultant PLX (PLacental eXpanded) cells are multi-potent, and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to their secretion of cytokines or other potent immune modulators. Furthermore, the PLX cells are immune-privileged and immunosuppressive, hence protecting the recipient from immunological reactions that often accompany transplantations.

Pluristem’s PLX-PAD is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). Pluristem has previously announced its PLX cells can be therapeutically beneficial in the treatment of a variety of other indications, such as ischemic stroke and Parkinson’s disease (PD).

The Company’s PLX-I is intended to resolve 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 (UCB).

Pluristem has offices in the USA with research and manufacturing facilities in Israel.

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. 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. For example, when we discuss our team ability to successfully meet the Company’s goal of building a pipeline of PLX products, leading the Company to future achievements and prosperity, we are using a forward looking statement. 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; 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.

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Source: Pluristem Therapeutics

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