Pluristem Therapeutics Inc. (NASDAQ: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 today that the results from Fraunhofer Institute’s additional pre-clinical study utilizing the Company’s proprietary PLacental eXpanded (PLX) cells in treating ischemic stroke showed statistical significance utilizing functional as well as anatomical endpoints. PLX cells are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX™ technology.
Fraunhofer Institute’s scientists systemically injected PLX cells into spontaneously hypertensive rats that had undergone middle cerebral artery occlusion, a commonly accepted ischemic stroke model. The functional endpoints of improvement in beam walking and neurological severity score and the anatomical endpoint of reduction in infarct size reached statistical significance versus controls.
Zami Aberman, Pluristem’s President and CEO said: “We are very excited about the results and believe that utilizing our PLX product may successfully treat millions of ischemic stroke patients and lead to a multi-billion dollar market. This independent study, together with the previously announced favorable pre-clinical results of PLX cells to treat limb ischemia and blood cancer, give us a robust pipe line for developing new therapeutic products.”
The trial was conducted under the supervision of Professor Frank Emmrich, Head of the Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany, a branch of the Fraunhofer Society.
Prof. Frank Emmrich stated, "PLX cells possibly show potential to become a new treatment for the functional recovery from a stroke. The data show that a double injection of PLX cells at two different time points significantly improve the functional recovery and reduce of size of the lesion compared to the control. However, these preliminary findings have to be confirmed and the running experimental series have to be completed before a final statement can be made. Additional optimization surrounding the administration of PLX cells will be required to supply clear evidence that PLX cells may help patients with ischemic stroke.”
About Ischemic stroke
Ischemic stroke accounts for approximately 90% of all stroke cases and is caused when an artery to the brain becomes blocked causing a sudden disruption of blood flow. Current estimates suggest ischemic stroke affects approximately 2 million patients annually worldwide with a large percentage dying or becoming permanently disabled. Industry leaders have estimated the potential market for treating ischemic stroke to be approximately $4 billion.
About Fraunhofer Institute for Cell Therapy and Immunology
The Fraunhofer Institute for Immunology and Cell Therapy (IZI) founded in April 2005 is member of the Fraunhofer Life Sciences Alliance. Its objective being to find solutions to specific problems at the interfaces between medicine, life sciences and engineering for partners active in medicine-related industries and businesses. The Institute’s core competencies are to be found in regenerative medicine, or more precisely in cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). In order for the living organism to accept the tissues without any difficulty, it is necessary to study cellular and immunological defense and control mechanisms and take these into account during process and product development. These core competencies entail a multiplicity of tasks to be solved by new products and processes. The Institute works especially closely with hospital institutions, performing quality tests and clinical studies on their behalf. Additionally it also provides assistance in obtaining manufacturing licenses and certifications.
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 the 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™ 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes 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, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company’s PLX-I product is intended to resolve 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 (UCB). PLX-STROKE shows potential to become a new treatment for the functional recovery from an ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel. www.pluristem.com
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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. 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. For example, when we say that our pre-clinical study in ischemic stroke shows statistically significant advantages in functional and anatomical recovery; that we believe that utilizing our PLX product may successfully treat millions of ischemic stroke patients and lead to a multi-billion dollar market; that this independent study, together with the previously announced favorable pre-clinical results of PLX cells to treat limb ischemia and blood cancer, give us a robust pipe line for developing new therapeutic product;, we are using a 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.
Contacts:
William Prather RPh, MD
Sr.
VP Corporate Development
303-883-4954
bill@pluristem.com
or
Fraunhofer
Contact:
Dr. Wilhelm Gerdes, +49-(0)-341/355-36-130
Fax:
+49-(0)-341/355-36-109
wilhelm.gerdes@izi.fraunhofer.de
