Pluristem Advances Phase I Study Of PLX-R18 Cells To Treat Insufficient Hematologic

Pluristem Therapeutics Inc. PSTI revealed that it advanced its Phase I study of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organization (CRO).

Pluristem said the trial got the FDA clearance earlier this year and enrollment was planned to commence in the coming months. The multi-center, open-label, dose-escalating Phase I study would assess the safety of intramuscular injections of PLX-R18 cells in 30 patients with incomplete hematopoietic recovery persistent for six months or more after HCT.

The company's chairman and CEO, Zami Aberman, said, "Data from this trial will inform the potential of PLX-R18 to treat a wide range of indications including blood cancers and radiation therapy-related blood diseases. The CRO we chose has extensive experience working with leading pharmaceutical and biotech companies to successfully manage clinical trials. We are excited to move forward to bring clinical sites online and begin enrolling patients."

Pluristem indicated PLX-R18 was designed to be administered without matching, and using a standard syringe to inject the cells intramuscularly. Data from different preclinical trials have shown that PLX-R18 cells secrete a range of specific proteins supporting the regeneration of bone marrow and the recovery of its ability to produce normal amounts of all three blood cell types.

In the pre-market on Monday, the stock traded 2.46 percent higher.