HAIFA, Israel, Oct. 12, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), 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.