Pluristem Therapeutics Announces First Patient Enrollment in Phase I Clinical Trial for Treatment of Peripheral Artery Disease With PLX-PAD

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HAIFA, Israel--(BUSINESS WIRE)--Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the first patient has been enrolled in a Phase I clinical trial of the Company’s allogeneic placental-derived adherent stromal cell product, termed PLX-PAD. PLX-PAD is being used in patients afflicted with critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The first patient was enrolled at the Franziskus-Krankenhaus Hospital, Berlin. The initiation of this study follows the recent approval of the Company’s Clinical Trial Application (CTA) to begin clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI), the German competent authority in the European Union. The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to fifteen adults with the disease will be included in the trial which is being conducted at the Franziskus-Krankenhaus Hospital and Charité – Universitätsmedizin Hospital, Berlin.

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Zami Aberman, Chairman, President and CEO of Pluristem stated, “We are proud to begin clinical trials with PLX-PAD, a cellular therapeutic product derived from the placenta, the organ intimately involved in the miracle of birth and a ubiquitous source of adult stromal cells that are easily obtained without harm to the mother or baby. Additionally, our proprietary three-dimensional mass manufacturing technology allows us to grow cells significantly more efficiently and cost-effectively than cells grown via the labor intensive two-dimensional method which is the industry norm."

About Pluristem

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), a “First-In-Human” placental-derived mesenchymanl-like stromal cell product, has received FDA and IMPD clearance and is being investigated in a Phase I clinical trial. The Company is developing a pipeline of products derived from human placenta, a non-controversial, non-embryonic, adult stem cell source. The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use, and require no histocompatibility matching.

These placental adherent stromal cells (ASCs) are expanded in the Company's proprietary PluriXTM 3D bioreactor system, which provides a 3D microenvironment that enables large-scale growth of these cells without the need for supplemental growth factors or other exogenous materials. PLX cells are immune privileged, possess immunomodulatory properties, and are expanded in vitro without showing signs of phenotypic or karyotypic changes. Pluristem believes that the PLX cells’ mechanism of action may be related to the secretion of cytokines and/or other potent immune modulators.

The Company's additional product candidates include PLX-IBD, targeting Inflammatory Bowel Disease, which includes Crohn’s disease and Ulcerative Colitis; PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.

Pluristem has offices in the USA with research and manufacturing facilities in Israel.

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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, when we discuss our proprietary three-dimension manufacturing technology and its advantage over a two-dimension method, we are using forward-looking statements. 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.

Pluristem Therapeutics Inc.
William Prather RPh, MD, +1-303-883-4954
Sr. VP Corporate Development
[email protected]