Pluristem Selects Fisher BioServices as Worldwide Dispatch Distributor of Its PLX Cell Therapies to Serve Global Clinical Studies
HAIFA, Israel, Sept. 27, 2012 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it has selected Fisher BioServices, Inc. as worldwide dispatch distributor of its off-the-shelf PLacental eXpanded (PLX) cells. Fisher BioServices will provide cryogenic storage and distribution of Pluristem’s PLX cells for its clinical trials and preclinical sites around the world.
Pluristem currently is targeting several therapeutics indications for which clinical trials and preclinical studies are in progress, which include: a) intermittent claudication; b) muscle regeneration c) critical limb ischemia d) Buerger’s disease; and e) acute radiation syndrome. The different studies are scheduled to take place in Europe, India, Israel and the U.S. In addition, Pluristem has reported strong pre-clinical study results in other indications for which the company may pursue clinical trials in the future. These include the treatment of acute myocardial infarction (heart attack), lung disease, and bone marrow disease. These indications collectively represent multibillion dollar treatment markets.
Fisher BioServices is the world’s leading provider of specialized biological sample and material management, and cell therapy logistics services to pharmaceutical and biotech companies, and national, state and academic institutions. Equipped to provide storage and cold chain transportation capabilities for the entire spectrum of cell-based and regenerative medicine worldwide, Fisher BioServices also provides distribution of cell-based therapies from manufacturer to patient bedside, with complete chain of custody documentation.
“As we expand our roster of clinical trials for our PLX cell therapies for several indications, we needed a reliable leader in cell therapy distribution. Fisher BioServices was the clear choice for us because they are the world’s leader in biological materials handling and have supported hundreds of clinical trials,” said Zami Aberman, Chairman and CEO of Pluristem.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (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 portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit http://www.pluristem.com, the content of which is not part of this press release. Follow Pluristem on Twitter@Pluristem.
CLICK HERE to watch a video where CLI patients and doctors involved with the clinical trials share their stories, the content of which is not part of this press release.
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, we are using forward looking statements when we discuss the indications we are targeting and their potential markets, and our related clinical trials and scheduled studies, when we say that data from two Phase I clinical trials indicate that Pluristem’s first PLX product, PLX-PAD, is safe and potentially effective for the treatment of end stage PAD or when we say that 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. 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 our clinical trials; 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; 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.
Pluristem Selects Fisher BioServices as Worldwide Dispatch Distributor of Its PLX Cell Therapies to Serve Global Clinical Studies
HAIFA, Israel, Sept. 27, 2012 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it has selected Fisher BioServices, Inc. as worldwide dispatch distributor of its off-the-shelf PLacental eXpanded (PLX) cells. Fisher BioServices will provide cryogenic storage and distribution of Pluristem’s PLX cells for its clinical trials and preclinical sites around the world.
Pluristem currently is targeting several therapeutics indications for which clinical trials and preclinical studies are in progress, which include: a) intermittent claudication; b) muscle regeneration c) critical limb ischemia d) Buerger’s disease; and e) acute radiation syndrome. The different studies are scheduled to take place in Europe, India, Israel and the U.S. In addition, Pluristem has reported strong pre-clinical study results in other indications for which the company may pursue clinical trials in the future. These include the treatment of acute myocardial infarction (heart attack), lung disease, and bone marrow disease. These indications collectively represent multibillion dollar treatment markets.
Fisher BioServices is the world’s leading provider of specialized biological sample and material management, and cell therapy logistics services to pharmaceutical and biotech companies, and national, state and academic institutions. Equipped to provide storage and cold chain transportation capabilities for the entire spectrum of cell-based and regenerative medicine worldwide, Fisher BioServices also provides distribution of cell-based therapies from manufacturer to patient bedside, with complete chain of custody documentation.
“As we expand our roster of clinical trials for our PLX cell therapies for several indications, we needed a reliable leader in cell therapy distribution. Fisher BioServices was the clear choice for us because they are the world’s leader in biological materials handling and have supported hundreds of clinical trials,” said Zami Aberman, Chairman and CEO of Pluristem.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (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 portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit http://www.pluristem.com, the content of which is not part of this press release. Follow Pluristem on Twitter@Pluristem.
CLICK HERE to watch a video where CLI patients and doctors involved with the clinical trials share their stories, the content of which is not part of this press release.
The Pluristem Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6882
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, we are using forward looking statements when we discuss the indications we are targeting and their potential markets, and our related clinical trials and scheduled studies, when we say that data from two Phase I clinical trials indicate that Pluristem’s first PLX product, PLX-PAD, is safe and potentially effective for the treatment of end stage PAD or when we say that 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. 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 our clinical trials; 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; 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.