IP addresses both 3D growth of placental and fat cells and the use of placental cells grown with 3D technology for the treatment of hematopoietic disorders
HAIFA, ISRAEL / CRWEPRESSRELEASE / April 13, 2016 -- Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that the Japan Patent Office has granted the Company two key patents addressing: 1) Pluristem’s core technology of three-dimensional expansion methods for producing therapeutic cell products derived from placental or fat cells; 2) the use of placenta-derived cells grown with this 3D technology to treat disorders of the hematopoietic system, such as disorders caused by exposure to radiation or chemotherapy, and failed engraftment of hematopoietic stem cell transplants. Pluristem continues to strengthen its IP position in order to support the current negotiations with pharmaceutical companies in Japan regarding potential partnerships for the development and commercialization of its PLacental eXpanded (PLX) cells. Pluristem recently received clearance for its protocol for a Phase 2 trial in critical limb ischemia targeting marketing approval in Japan, via Japan’s accelerated regulatory pathway for regenerative medicines.
Patent No. 5733894, titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy”, covers three-dimensional methods of growing adherent placental or adipose cells, and the cells produced by the claimed methods.
Patent No. 5766041, titled “Pharmaceutical Composition for Enhancing Subject Hematopoietic System”, addresses pharmaceutical compositions containing placental stromal cells grown using 3D culturing methods for supporting engraftment of hematopoietic progenitor cells, thus enabling treatment of disorders of the hematopoietic system by promoting the recovery of the immune system and bone marrow function.
“These latest patent grants in Japan fortify our intellectual property position globally, and specifically in the Japanese market, where we are in active negotiations with potential pharmaceutical partners,” stated Pluristem Chairman and CEO Zami Aberman. “Our proprietary process and technology for growing placenta-derived cells within a 3D microenvironment make large scale, cost effective cell therapy production a reality, and IP protection of these methods in Japan is a key asset. The use of these cells to treat disorders of the hematopoietic system is an important indication for PLX cells that is now protected in Japan.”
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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, forward-looking statements are used in this press release when we discuss potential partnerships for the development and commercialization of our PLX cells in Japan, when we discuss our plan to obtain marketing approval in Japan via Japan’s accelerated regulatory pathway for regenerative medicines and the statement that our proprietary process and technology for growing placenta-derived cells within a 3D microenvironment make large scale, cost effective cell therapy production a reality. These forward-looking statements and their implications 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.
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Source: Pluristem Therapeutics Inc