Pluristem's PLX-MS Shows Potential Benefit in the Prevention of Multiple Sclerosis

Monday August 11, 7:00 am ET

NEW YORK--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, today announced that the Company’s PLacental eXpanded (PLX-MS) cells have demonstrated in vivo efficacy in the prevention of Multiple Sclerosis (MS). PLX cells are Pluristem’s placental-derived mesenchymal stromal cells (MSCs) that have been expanded in the Company’s proprietary PluriX™ 3-D bioreactor.

In a further analysis aiming to demonstrate the in vivo efficacy of PLX-MS cells for the prevention of MS, Experimental Autoimmune Encephalitis (EAE) was induced in mice via immunization with the MOG35-55 protein on day 0. EAE is an autoimmune inflammatory disease of the CNS that represents the paradigmatic model for MS. The animals then received, on day 8, intravenously either PLX-MS or PlasmaLyte, which served as a control. PLX-MS administration prevented the appearance of clinical symptoms and signs associated with MS throughout the 35-day study period compared to those animals receiving the control. Additionally, the beneficial effects were similar to when Zappia et. al. used MSCs that were non-placental in origin in this EAE animal model†.

Mr. Zami Aberman, Pluristem’s President and CEO, commented: “This trial’s remarkable results demonstrated our PLX-MS cells’ ability to prevent the appearance of multiple sclerosis symptoms and showed the potential for our PLX cells to treat global autoimmune diseases. As a cellular therapy, our PLX cells, which are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source, and stored ready-to-use, could prove to be a readily available preventive therapeutic alternative for these disorders."

Pluristem is initiating repeated sets of EAE experiments at the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charité - University Medicine Berlin, one of the largest independent clinical research centers in Europe.

†Zappia et. al. Mesenchymal stem cells ameliorate experimental autoimmune encephalitis inducing T cell anergy. Blood. 2005;106: 1755-1761

About Multiple Sclerosis (MS)

Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminate, is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. Myelin is the insulating sheath that surrounds nerve cells (neurons). MS may cause numerous physical and mental symptoms, and often progresses to physical and cognitive disability. The World Health Organization (WHO) estimates that over 2.5 million people globally suffer from MS, which represents a current market of approximately $5.4 billion for disease-modifying agents to treat the disorder.

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 human placenta, a non-controversial, non-embryonic, adult stem cell source.

These placental mesenchymal stromal cells (MSCs) are expanded in the Company's proprietary PluriXTM 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes that 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 the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and have 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 Company's products in development also include 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; PLX-STROKE, targeting ischemic stroke; PLX-MS, targeting Multiple Sclerosis; and PLX-IBD, targeting Inflammatory Bowel Disease (IBD), which includes Crohn’s disease and Ulcerative Colitis.

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

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 say that the trial’s remarkable results demonstrated our PLX-MS cells’ ability to prevent the appearance of multiple sclerosis symptoms and showed the potential for our PLX cells to treat global autoimmune disease, or that as a cellular therapy, our PLX cells could prove to be a readily available preventive therapeutic alternative for these disorders, 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; 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.

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




Contact:

Pluristem Therapeutics Inc.
William Prather RPh, MD, 303-883-4954
Sr. VP Corporate Development
bill@pluristem.com

Source: Pluristem Therapeutics Inc.

Pluristem's PLX Cells Show a Statistically Significant Advantage in a Pre-Clinical Study in the Multiple Sclerosis Model

2008-04-14 20:16:34 -

Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT) a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that a preclinical study utilizing the Company's PLacental eXpanded (PLX) cells showed a statistically significant advantage in ameliorating functional deficiencies in a standard Multiple Sclerosis (MS) animal model. PLX cells are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX(TM) technology.

Researchers at Pluristem utilized the Experimental Autoimmune Encephalitis (EAE) animal model for the study, the paradigm for MS in humans. After EAE was induced, a number of the animals were given PLX cells intravenously while the remaining served as a control. There was a significant reduction in the EAE score in those animals given PLX cells versus the control group and this beneficial effect was seen throughout the 25-day duration of the study. The EAE score is a measurement of functional outcomes in the EAE-afflicted animal and correlates closely with a histological improvement in EAE-induced lesions. Additionally, the beneficial effects were similar to when Zappia et. al. used MSCs that were non-placental in origin in this EAE animal model(1).

Zami Aberman, Pluristem's President and CEO said: "We are very excited that our PLX cells were able to demonstrate beneficial results that are statistically significant in this standardized model for Multiple Sclerosis. These results, in addition to our previously announced PLX STROKE results, demonstrate that PLX cells may be useful in the treatment of central nervous system (CNS) disorders and potentially help millions of people. Additionally, we believe this experiment demonstrates we can potentially utilize our off-the-shelf, easy to obtain PLX cells and achieve results that are as good as or better than MSCs obtained from other more difficult to find sources."

(1)Zappia et. al. Mesenchymal stem cells ameliorate experimental autoimmune encephalitis inducing T cell anergy. Blood. 2005;106: 1755-1761

About Multiple Sclerosis (MS)

Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminate, is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. Myelin is the insulating sheath that surrounds nerve cells (neurons). MS may cause numerous physical and mental symptoms, and often progresses to physical and cognitive disability. The World Health Organization (WHO) estimates that over 2.5 million people globally suffer from MS, which represents a current market of approximately $5.4 billion for disease-modifying agents to treat the disorder.

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, non-embryonic, adult stem cell source.

These placental mesenchymal stromal cells (MSCs) are expanded in the Company's proprietary PluriX(TM) 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 the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and have immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.

Pluristem's first product, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company's PLX-I product 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). PLX-STROKE shows potential to become a new treatment for the functional recovery from an ischemic stroke.

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

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

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 say that the Company's PLacental eXpanded (PLX) cells showed a statistically significant advantage in ameliorating functional deficiencies in a standard Multiple Sclerosis (MS) animal model; that these results, in addition to our previously announced PLX STROKE results, demonstrate that PLX cells may be useful in the treatment of central nervous system (CNS) disorders and potentially help millions of people; that we believe this experiment demonstrates we can potentially utilize our off-the-shelf, easy to obtain PLX cells and achieve results that are as good as or better than MSCs obtained from other more difficult to find sources, we are using 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; 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.

Pluristem Therapeutics Inc.
Investor Contact:
William Prather RPh, MD, Sr. VP Corporate Development
303-883-4954
bill@pluristem.com

Pluristem and Center for Regenerative Therapies at Charite University Hospital of Berlin Enters into Collaborative Research Agreement

Jul 9 2007, 8:00 AM EST

Business Wire

Pluristem Life Systems, Inc. (OTCBB:PLRS) (DAX:PJT), a bio-therapeutics Company dedicated to the commercialization of products for a variety of malignant, degenerative and auto-immune indications, announced today that it has entered into a Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charite - University Medicine Berlin.

Pluristem and BCRT will collaborate on a variety of indications utilizing mesenchymal stem cells (MSCs) derived from the placenta that have been expanded in the Company's proprietary PluriX(TM) 3-D bioreactor. The initial focus of the collaboration will be on neurological indications such as Multiple Sclerosis and Parkinson's disease. The agreement also covers organ transplantation and cardiovascular indications such as inflammatory cardiomyopathy. Pluristem will be the exclusive owner of the technology and any products stemming from the collaboration.

Professor Hans Dieter Volk, MD, Director/ Chairman of BCRT at Charite commented, "The collaboration of BCRT, working with Pluristem and their proprietary PLX cells offers several exciting prospects. We believe Pluristem's cells can potentially result in beneficial therapies for a number of diseases."

The BCRT is a cooperative research institution of the Charite University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. BCRT also receives generous financial support from the BMBF and the states of Berlin and Brandenburg, as well as from the Technology Foundations in Berlin and Brandenburg, the Future Fund Berlin and from various industry partners. More than 15 regional partners from science and industry are active members of the consortium at the BCRT.

"This cooperation is extremely important to us," commented Pluristem Chairman and CEO, Mr. Zami Aberman. "First, it corroborates our approach regarding the use of MSCs from the placenta and our PluriX(TM) technology to develop new therapeutic products for a variety of indications. In addition, the collaboration significantly enhances our approach to develop our pipe line of products."

About BCRT

The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charite University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. BCRT also receives generous financial support from the BMBF and the states of Berlin and Brandenburg, as well as from the Technology Foundations in Berlin and Brandenburg, the Future Fund Berlin and from various industry partners. The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench-to-bedside. The five clinical platforms -- Immune, muskuloskleletal, hepatic, neuronal, and cardiovascular system -- are cross-linked by technology platforms (basic science, bio-engineering, translational technologies). First clinical trials with cell therapy have been started.

www.b-crt.de

About Pluristem

Pluristem Life Systems, Inc. is a Company dedicated to the commercialization of non-personalized (allogeneic) stem cell therapy products for the treatment of numerous severe degenerative, malignant and autoimmune disorders. The Company's first planned product, PLX-I, targets a $2 billion market and 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 (CB).

Pluristem's products are derived from mesenchymal stem cells (MSCs) obtained from the placenta and expanded in the Company's proprietary PluriX(TM) 3D bioreactor that imitates the natural microstructure of bone marrow and does not require supplemental growth factors, cytokines or other exogenous materials. Pluristem believes the resultant expanded cells, termed PLX cells, are multipotent and able to differentiate into a variety of cell types as well as being immune-privileged to protect the recipient from immunological reactions that often accompanies transplantation. Pluristem believes their future products will participate in the approximate $30 billion therapeutic and regenerative cellular market.

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

www.pluristem.com

Safe Harbor Statement

This press release contains statements, which may constitute "forward-looking statements" regarding our intent, belief or current expectations. Forward-looking statements in this release include that "the Pluristem's cells can potentially result in beneficial therapies for a number of diseases; that the collaboration corroborates our approach regarding the use of MSCs from the placenta and our PluriX(TM) technology to develop therapeutic products for a variety of indication; that the corroborates our approach regarding the use of MSCs from the placenta and our PluriX(TM) technology to develop new therapeutic products for a variety of indications; that the collaboration significantly enhances our approach to develop our pipe line of products. Factors that could prevent our forward looking statements from being achieved include that we may be unable to get regulatory approval for our products; we may be unsuccessful in developing any products; 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 to protect essential aspects of our technology; competitors may invent better technology; our products may not work as well as hoped or worse, our products may harm recipients; and we may not be able to raise funds for development or working capital when we require it. As well, our products may never develop into useful products and even if they do, they may not be approved for sale to the public. For further risk factors see the Company's latest 10-KSB filed with the SEC.