Pluristem Completed Successful Meeting With FDA in Preparation for Filing an IND for PLX-R18

Pluristem Therapeutics Inc.

today announced that it has completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the initiation of a Phase I clinical trial for its PLX-R18 cells in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation. Hematopoietic stem cells, which produce the body's blood cells, are transplanted in various settings to facilitate regeneration of the hematopoietic system, for example in the context of certain cancers or immune-mediated bone marrow failure. During Pluristem's meeting with the FDA, the regulatory agency communicated that the preclinical data presented by the company would support an Investigational New Drug (IND) application to test PLX-R18 in humans. The Company also presented the design of its proposed Phase I study to the FDA. Pluristem anticipates initiating the Phase I trial in the U.S. in early 2016.   "We were very pleased with the positive outcome of our recent FDA meeting. The timeline for our IND submission and anticipated clearance by the FDA are in line with the timetable and strategy we outlined earlier this year regarding the development of PLX-R18," stated