HAIFA, Israel, April 20, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced that its Clinical Advisory Board for Critical Limb Ischemia (CLI) concluded a key meeting in London, England. During the meeting, Clinical Advisory Board members, including Key Opinion Leaders in the treatment of CLI, outlined the Phase II study design and other critical components of advanced-stage trials for the Company’s PLacental eXpanded (PLX) cells in the treatment of this peripheral artery disease.
Pluristem has applied to conduct Phase II trials for CLI in regions with recently established rapid regulatory pathways, including the Accelerated Pathway for Regenerative Therapy in Japan and the Adaptive Pathway in the European Union.
“We believe PLX-PAD could potentially be three years from commercialization, contingent upon successful trials and approval via accelerated regulatory pathways in Japan and Europe. Our Clinical Advisory Board has provided invaluable expertise in generating our Phase II trial protocols, and we are eager to move forward with them,” stated Zami Aberman, Pluristem’s Chairman and CEO.
Two Phase I studies for CLI, previously completed in the U.S. and Germany, met all primary endpoints. Data from these trials suggested that the cells were safe and potentially efficacious at multiple dosage levels in this indication.
