Pluristem Therapeutics Inc. (Nasdaq: PSTI) (DAX: PJT) today announced the results of two separate pre-clinical studies in animal models which demonstrated that its PLacental eXpanded (PLX) cell therapy may be an effective treatment for both neuropathic and inflammatory nerve pain. These animal studies were conducted in collaboration with the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) and the Department of Anesthesiology and Operative Intensive Care Medicine, both at the Charité-Universitätsmedizin of Berlin, Germany. The animal models included those with neuropathic pain induced by ligation of the Sciatic nerve and those with inflammatory pain induced by the injection of Complete Freund’s Adjuvant into the animal’s footpads. Following the administration of PLX cells, the sensitivity to thermal and mechanical stimuli was dramatically reduced in both models with the reduction in pain correlated with the number of injected PLX cells in a dose dependent manner. Hans-Dieter Volk, Ph.D., professor of immunology and chair of the Institute of Medical Immunology Charité - Universitätsmedizin Berlin and Berlin-Brandenburg Center for Regenerative Therapies (BCRT) stated, “We initiated this study at Prof. Stein´s research unit (Dept. Anesthesiology) based on research indicating that the pathophysiology surrounding neuropathic pain involves inflammation and ischemia of the affected nerves and data from Pluristem showing that the mechanism of action of PLX cells involves secretion of anti-inflammatory and angiogenic cytokines that promote new vessel formation (angiogenesis) into the injured tissue.” “These findings demonstrate again that the therapeutic effect of Pluristem’s PLX cells is achieved through the release of cytokines that act on local, or perhaps distant, target tissues. Rather than serving as stem cells to repair tissues, they serve as cellular factories that secrete mediators to stimulate the repair of tissues or other beneficial effects,” said Dr. Edwin Horwitz, Chairman of Pluristem’s Scientific Advisory Board and President of the International Society for Cellular Therapy. These findings, in addition to previous Pluristem publications, position PLX cells as a promising candidate for a variety of clinical indications.
Zami Aberman, Chairman and CEO of Pluristem, added, “These results provide evidence of our PLX cells being potentially effective for treating neuropathic pain arising from a variety of reasons, such as diabetes and chemotherapy. We look forward to moving with these findings into a clinical study, supported by a partner that will help Pluristem pursue commercialization of its PLX cells for this indication.”About Neuropathic Pain Neuropathic pain is a chronic pain state that is usually accompanied by tissue injury. With neuropathic pain, the nerve fibers themselves may be damaged, dysfunctional or injured. Common causes of neuropathic pain include diabetes, alcoholism, chemotherapy and infections such as herpes zoster (shingles). There is no standard of care for neuropathic pain with a multitude of agents ranging from analgesics to antidepressants and anticonvulsants used to treat the disorder. Industry analysts have predicted the neuropathic pain market to approach $5.5B by 2015 1. About the Berlin Bradenburg Center for Regenerative Therapies The Berlin Bradenburg Center for Regenerative Therapies, a translational center of the Charité - Universitätsmedizin Berlin and the Helmholtz Foundation has developed an internationally visible center of excellence in regenerative medicine with a focus on endogeneous regeneration through the application of cells, biological factors, biomaterials, or combinations. The Center strives to translate basic science discoveries into regenerative therapies and share scientific knowledge generated in the field of regenerative medicine with researchers, clinicians, and the public through educational activities, training, publications, and communication forums at the national and international level. About Pluristem Pluristem is a clinical stage biotechnology company with proprietary technology for the development and manufacturing of standardized cell therapies derived from the human placenta. Pluristem’s patented and scalable PLX (PLacental eXpanded) cell product candidates are developed as readily available for the treatment of critical limb ischemia (CLI) and other diseases.
See our product animation on YouTube: Animation, the content of which is not part of this press release.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 the findings of the two separate pre-clinical studies in animal models, in addition to previous Pluristem publications, position PLX cells as a promising candidate for a variety of clinical indications or that these results provide evidence of our PLX cells being potentially effective for treating neuropathic pain arising from a variety of reasons, such as diabetes and chemotherapy or that we look forward to moving with these findings into a clinical study, supported by a partner that will help Pluristem pursue commercialization of its PLX cells for this indication . 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.
For more information visit our website at www.pluristem.com, the content of which is not part of this press release.1 http://www.piribo.com/publications/therapeutic/cns_neurology/commercial_insight_neuropathic_pain.html