Potential to Address Multi-Billion Markets Where Fibrosis is End Stage of Inflammatory Process
Data to be Presented at the Israel Society for Placenta Research Conference
HAIFA, Israel, Oct. 17, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced that a reduction of fibrotic processes has been demonstrated in preclinical and in in-vitro studies using Pluristem's Placental eXpanded (PLX) cells. Lena Pinzur MSc, Pluristem's Basic and Preclinical Research Manager will present data at the 3rd Annual Meeting of the Israel Society for Placenta Research on October 18, 2012.
"Demonstrating that our PLX cells can potentially act as potent anti-fibrotic agents positions us to penetrate several multi-billion dollar markets where fibrosis is the end stage of an inflammatory process," said Zami Aberman, Chairman and CEO of Pluristem. "We will continue our research into this important characteristic of our cells that will enable us to add the prevention of fibrosis to our growing list of indications for our PLX cells."
Fibrosis, defined as the overgrowth, hardening, and/or scarring of various tissues as the end result of chronic inflammation, can result from a variety of stimuli that includes chronic infections, autoimmune reactions, allergic responses, chemical and radiation insults, radiation, and other causes of tissue injury. Fibrosis can occur in virtually any organ, including the heart, liver, kidney and lung. The fibrotic reaction is attributed to an excessive deposition of extracellular matrix components including collagen and fibronectin.
The basis for Pluristem's hypothesis that PLX cells act as anti-fibrotic agents comes from animal models given Bleomycin, an anti-cancer agent, known to induce pulmonary fibrosis and widely used to study the mechanisms involved in fibrogenesis. Bleomycin induces chromosomal DNA strands to break, which results in pulmonary inflammation and subsequent fibrosis.
In the experiments, 8-10 week old male mice were randomized to receive Bleomycin alone or Bleomycin plus PLX cells administered into the trachea. Mice that received only Bleomycin served as controls. Pertinent results at 21 days include a statistically significant improvement in oxygen saturation (p<0.05), monitored on a weekly basis during the study and a significant reduction in the collagen (p <0.001) deposition in the lungs when examined histologically. This information may suggest that the PLX cells are reactive to the fibrotic environment.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.
Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia; PLX-BMP for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.
Pluristem has a strong patent and patent applications portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, follow Pluristem on Twitter@Pluristem, the content of which is not part of this press release.
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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 that PLX cells can potentially act as anti-fibrotic agents to reduce fibrotic processes, that PLX cells can potentially address multi Billion markets where Fibrosis in the end stage of inflammatory process, that our products can potentially treat systemic diseases and potentially obviate the need to use the intravenous route, that data from two phase I indicates that PLX-PAD is safe and potentially effective for the treatment of end stage peripheral artery disease, when we discuss other product candidates that we develop and their intended use, or when we discuss how pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, 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 and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, 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; results of preclinical studies may not correlate with the results of human clinical trials; 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.