Pluristem Therapeutics Inc. on Wednesday announced it has completed a successful meeting with the U.S. Food and Drug Administration (FDA) about the start 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 produce the body's blood cells and are transplanted in various settings to enable regeneration of the hematopoietic system, such as in the cases of certain cancers or immune-mediated bone marrow failure.
During the meeting, the FDA said that the preclinical data presented by the company would support an Investigational New Drug (IND) application to test PLX-R18 in humans. Pluristem also presented the design of its proposed Phase I study to the FDA.
"We were very pleased with the positive outcome of our recent FDA meeting,” Pluristem CEO Zami Aberman said. “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.”
Pluristem anticipates that the Phase I trial in the United States will be initiated in early 2016.
Pluristem Therapeutics Inc. is a developer of placenta-based cell therapy products. Pluristem has a large intellectual property position including company-owned, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.