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(December 07, 2017)
- Data from Phase II-equivalent study demonstrated improved survival and hematological recovery of non-human primates (NHP) exposed to high levels of radiation
- PLX-R18 cells are in late-stage development as a treatment for ARS, supported by the U.S. National Institutes of Health (NIH)
HAIFA, Israel, Dec. 07, 2017 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today the company will present data from its Phase II-equivalent study of PLX-R18 cells for the treatment of acute radiation syndrome (ARS) at the American Society of Hematology’s (ASH) 59th Annual Meeting to be held in Atlanta, Georgia, on December 9-12, 2017.
The results of the study will be presented during Program Session 506: Hematopoiesis and Stem Cells: Microenvironment, Cell Adhesion, and Stromal Stem Cells. The poster, “Intramuscular Administration of Placenta-Derived Stromal Cells Enhances Survival of Rhesus Macaque Monkeys Exposed to Total Body Irradiation,” will describe data from a recently announced Phase II-equivalent study under the U.S. Food and Drug Administration (FDA) Animal Rule. The data demonstrate improved survival and hematological recovery of NHPs exposed to different levels of radiation. This study was conducted and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The poster abstract will be published online in the supplemental volume of Blood, a peer-reviewed medical journal published by ASH.
“We are excited to present these promising data on our PLX-R18 cells in the treatment of ARS to the world’s thought leaders in hematology at this year’s ASH conference,” said Yaky Yanay, president and Co-CEO of Pluristem. “We believe that there is a crucial need for a therapy capable of effectively treating populations in case of nuclear or radioactive incidents. These findings, which show recovery of the hematologic system, suggest that PLX-R18 has the potential to treat a large population exposed to different levels of radiation and might also be used for additional hematologic indications.”
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charite in Berlin and other prominent research institutions, have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.
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, and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. 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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when its discusses that PLX-R18 has the potential to treat a large population exposed to different levels of radiation and might also be used for additional hematologic indications, and the potential market for such indications. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH
Divisional VP, North America
Head of Investor and Public Relations
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