HAIFA, Israel, March 15, 2011 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) and New York University (NYU) Medical Center today announced the formation of a partnership to study the use of Pluristem's proprietary placenta-derived PLX cells for the treatment of Diabetic Foot Ulcers (DFU). Weiliam Chen, R.Ph. Ph.D., Director of the Tissue Engineering Research Laboratory, Department of Surgery at NYU's Helen L. and Martin S. Kimmel Wound Healing Center, will be the principal investigator (PI) of these pre-clinical studies, which are the first step towards a future potential Phase II clinical study for treatment of DFU.
An in vitro and a series of animal models will be used to evaluate the role PLX cells have in healing DFU. Through a novel academic-industrial collaborative research paradigm, these trials, with proposed support from the National Institutes of Health (NIH), will be used as a bridge towards the potential treatment of patients with diabetic foot ulcers.
"Diabetes affects over 170 million people worldwide and more than 20 million Americans with the prevalence expected to double by 2030. Chronic diabetic foot ulcers are the leading cause of lower extremity amputations," said Dr. Chen. "No new therapy for diabetic chronic wounds has been introduced into clinical use since 1998 and there is a critical unmet need for innovative therapies able to accelerate DFU healing, prevent amputation and reduce associated morbidity and mortality."
The Center for Disease Control (CDC) reports that approximately 12% of patients afflicted with diabetes develop a foot ulcer. This translates into approximately 2.5 million patients with foot ulcers in the U.S. alone.
"This partnership with Pluristem is important to developing an innovative advanced cellular therapy," added Dr. Chen. "Many diabetic patients have advanced atherosclerosis and have lower extremity vascular insufficiencies. Pluristem's PLX cells can stimulate angiogenesis, which is highly advantageous in treating diabetic chronic wounds. Besides, the PLX cells can directly address cellular impairment in diabetic wounds leading to tissue regeneration in the wound beds."
"We are very proud to be working with a world-renowned expert such as Dr. Chen and partnering with the NYU Medical Center in using PLX cells for the potential treatment of Diabetic Foot Ulcers," said Zami Aberman, Chairman and Chief Executive Officer of Pluristem. "Our PLX-PAD cells have been shown to be safe and potentially effective and to improve the quality of life in patients with Peripheral Artery Disease (PAD), some of whom had suffered from ulcers. We are, therefore, excited about testing the PLX cells' effectiveness in treating DFU."
About the Helen L. and Martin S. Kimmel Wound Healing Center at NYUMC
The Helen L. and Martin S. Kimmel Wound Healing Center's mission is to eliminate limb loss in patients with lower extremity wounds and rapidly treat pressure ulcers before non-healing and complications ensue. The Kimmel program is unique in that it has members of eight departments available or involved in the care of each wound patient personified by the contributions from NYU faculty in the departments of Orthopedic Surgery, Medicine, Emergency Medicine, Plastic Surgery, Psychiatry, Dermatology, Anesthesia and Physiatry.
The Kimmel Center treats the elderly, disabled and those with diabetes who suffer with wounds in a personal and caring environment that involves patients and their families at every level of care. Under the Kimmel Centre's innovative, comprehensive, and compassionate care system, healing is not just an outcome, it's the expectation. This philosophy that every wound can heal is predicated on 29 years of study on the cellular basis of healing – from the clinic to the operating room to the research laboratories.
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 drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory 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 or immune-suppression treatment prior to administration. The PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20 million patients in the Peripheral Artery Disease (PAD) market.
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. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage when administered locally and in inflammatory bowel disease, MS and stroke when administered systemically.
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 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 in the clinical trials share their stories. CLICK HERE to see Pluristem's cell therapy product animation on YouTube.
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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, we are using forward looking statements when we say that these trials, with proposed support from the National Institutes of Health (NIH), will be used as a bridge towards the potential treatment of patients with DFU, or that the Company is aiming to enter into a Phase II clinical study for treatment of DFU; or that our PLX cells can stimulate angiogenesis, which is highly advantageous in treating diabetic chronic wounds, or that PLX cells can directly address cellular impairment in diabetic wounds leading to tissue regeneration in the wound beds, or that we are partnering with the NYU Medical Center in using PLX cells for the potential treatment of DFU, or that our PLX-PAD cells have been shown to be safe and potentially effective and to improve the quality of life in patients with Peripheral Artery Disease (PAD), some of whom had suffered from ulcers, and we are therefore excited about testing the PLX cells' effectiveness in treating DFU, or that our pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage when administered locally and in inflammatory bowel disease, MS and stroke when administered systemically. 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.