Pluristem contracts CRO for Phase I trial of PLX-R18

Pluristem has advanced its Phase I trial of PLX-R18 cells to treat insufficient haematopoietic recovery following haematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organisation (CRO).

Haematopoietic cell transplantation is a standard treatment for a range of conditions, including malignant diseases such as multiple myeloma, non-Hodgkin’s lymphoma, Hodgkin’s disease, and acute myeloid leukaemia, as well as non-malignant diseases and autoimmune disorders.

In a number of cases, complete haematopoietic recovery following HCT is not reached, and patients are at increased risk of bleeding, infection, poor general function and death for months afterwards. Current treatments include administration of factors stimulating growth of specific blood cell types, such as granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and erythropoietin. However, a significant number of patients do not respond to growth factors and may require frequent transfusions, which expose them to transfusion-related risks such as allo-sensitisation and infections, without providing a curative solution. These are also associated with significant costs.

Trial enrolment begins soon

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

The Phase I trial will evaluate the safety of intramuscular injections of PLX-R18 cells in 30 patients with incomplete haematopoietic recovery persistent for 6 months or more after HCT. Trial enrolment is expected to begin in the coming months.

Explaining more about the trial and the contract with the CRO, Zami Aberman, Pluristem Chairman and CEO, 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.”