Haifa, Israel -- (SBWIRE) -- 10/13/2015 -- Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, today announced it has expanded its five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité - University Medicine Berlin. The expanded agreement, which was executed on October 11th at the Berlin-Tel Aviv Business Forum in Tel Aviv, broadens the parties' cooperation to include identification of orthopedic indications that may be eligible for development under Europe's Adaptive Pathways and conditional marketing approval in the European Union. Pluristem's program to develop PLX cells in critical limb ischemia is already under discussion with the EMA and other European Stakeholders under the Adaptive Pathways.
Under the five-year Collaborative Research Agreement, Pluristem and Charité have jointly completed a successful orthopedic Phase I/II study using PLacental eXpanded (PLX) cells in muscle injury. The parties have also collaborated on a variety of other indications, including kidney diseases such as acute kidney injury, cardiovascular indications such as inflammatory cardiomyopathy, and comprehensive immunological research for Pluristem's Peripheral Artery Disease clinical programs.
Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité, who served as Senior Scientist on the completed Phase I/II orthopedic study, commented, "In our studies PLX cells demonstrated the potential to improve overall muscle functionality, with an impressive magnitude of effect. An additional orthopedic PLX indication has a promising potential."
"Pluristem has enjoyed a very productive relationship with European regulators and our PLX cells have already been selected for the Adaptive Pathways in critical limb ischemia. Working with the prestigious Charité, we look forward to advancing an orthopedic indication through Adaptive Pathways as well," stated Pluristem Chairman and CEO, Zami Aberman.
The Berlin-Brandenburg Center for Regenerative Therapies was founded as a cooperative research institution of the Charité University Hospital in Berlin and Germany's largest research association, the Helmholtz Association. The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench-to-bedside. The five clinical platforms–Immune, musculoskeletal, hepatic, neuronal, and cardiovascular system–are cross-linked by technology platforms (basic science, bio-engineering, translational technologies.
About Adaptive Pathways
The purpose of Europe's Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways Discussion Group provides detailed guidance to the applicant previous to the formal regulatory processes that precede a trial targeting early or conditional approval and further expansion of the indications.
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, 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, we are using forward-looking statements when we discuss PLX cells' potential to improve overall muscle functionality with an impressive magnitude of effect, when we discuss the potential of the orthopedic PLX indication to be a promising clinical program and when we discuss our plans to continue to work with Charité to advance an orthopedic indication through Adaptive Pathways as well. For example. we are using forward-looking statements when we discuss the findings of the scientific study and the evidence they provide, that the research may lead to a new understanding of how PLX cells influence and potentially heal the immune system through paracrine and endocrine effects, and opens the window for the use of PLX cells for new indications, or that the data from the study suggest the potential for PLX cells to treat a range of severe conditions related to immune function, or that PLX cells could potentially help treat diseases of the immune system such as aplastic anemia, and autoimmune diseases such as multiple sclerosis, lupus and graft versus host disease (GVHD). 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 clinical 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.