Pluristem Gets FDA Nod To Begin Phase I Trial Of PLX-R18

(RTTNews) - Pluristem Therapeutics Inc. (PSTI), a developer of placenta-based cell therapy products, said the U.S. Food and Drug Administration cleared the company's Investigational New Drug application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation or HCT. The clinical trial is expected to begin in the first half of 2016.

PLX-R18 is Pluristem's second cell therapy product cleared for clinical studies by the U.S. FDA. It has already been studied in preclinical models of acute radiation syndrome, support of hematopoietic cell transplants, and side effects of radiotherapy and chemotherapies used to treat cancers.

Preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the resurgence of progenitor cells, supporting the recovery of blood cell counts.

By this mechanism of action, PLX-R18 could potentially treat a broad range of hematologic indications.

Pluristem Chairman and CEO Zami Aberman said, "The PLX-R18 product is designed to be an entirely new and innovative treatment approach for a wide variety of hematopoietic disorders, and might save the lives of severely ill patients with no alternative treatment options. We are encouraged by the strong pre-clinical data, and intend to pursue early market access in the U.S. for this important clinical indication."