Pluristem Demonstrates The Potential Of Its PLX Cells To Treat Crohn's Disease And Ulcerative Colitis

Main Category: Crohn's
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 29 May 2008 - 4:00 PDT

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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, announced that the Company's PLacental eXpanded (PLX) cells have demonstrated in vivo efficacy in the treatment of Crohn's Disease and Ulcerative Colitis, collectively termed Inflammatory Bowel Disease (IBD). PLX cells are Pluristem's placental-derived mesenchymal stromal cells (MSCs) that have been expanded in the Company's proprietary PluriX™ 3-D bioreactor.

Mice and rats each received intrarectal administration of trinitrobenzene sulphonic acid (TNBS), a standard method for inducing IBD in animal models. The macroscopic and microscopic anti-inflammatory effects of the intravenous administration of PLX-IBD cells were then evaluated and compared to control animals that received only saline. PLX-IBD cell therapy significantly reduced the TNBS-induced colon lesions both in the macroscopic and microscopic evaluations compared to the control animals and to animals given therapy that is currently the standard of care in IBD.

Mr. Zami Aberman, Pluristem's President and CEO, commented: "This trial's favorable results, which demonstrate our PLX cells' ability to treat Inflammatory Bowel Disease, as well as our previous studies indicating their potential use to help Multiple Sclerosis patients, show the potential for our PLX cells to treat global autoimmune diseases. We believe that the unique capabilities of our PLX cells will lead to cooperative efforts between Pluristem and other significant players in the field of autoimmune diseases to benefit millions of patients. As a cellular therapy, our PLX cells, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source and are stored ready-to-use, could prove to be a readily available therapeutic alternative or addition for these disorders."

About IBD

Ulcerative colitis and Crohn's disease, known collectively as Inflammatory Bowel Disease (IBD), currently affect 0.5-1% of the Western world's population. This translates to over one million people in America (525,000 Ulcerative Colitis, 490,000 Crohn's Disease) and four million people worldwide. Sufferers experience a range of gastrointestinal symptoms, including diarrhea, rectal bleeding and abdominal pain. Children with IBD suffer delayed growth and sexual maturation. Ulcerative colitis is restricted to the colon while Crohn's disease can affect all regions of the gastrointestinal tract. Because IBD is chronic and typically has an onset before 30 years of age, patients generally require lifelong treatment. The estimated market for treatment of IBD is over $2 billion.

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 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 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 patients suffering from 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.

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 this trial's favorable results, which demonstrate our PLX cells' ability to treat Inflammatory Bowel Disease, as well as our previous studies indicating their potential use to help Multiple Sclerosis patients, show the potential for our PLX cells to treat global autoimmune diseases, or that we believe that the unique capabilities of our PLX cells will lead to cooperative efforts between Pluristem and other significant players in the field of autoimmune diseases to benefit millions of patients, or that as a cellular therapy, our PLX cells that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source, and are stored ready-to-use, could prove to be a readily available therapeutic alternative or addition 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.

Pluristem Therapeutics Inc.