PLacental eXpanded (PLX) cells are placenta-derived, mesenchymal-like adherent stromal cells that are expanded ex vivo and are designed to be administered to patients without the need for tissue or genetic matching. These cells release soluble biomolecules, such as cytokines, chemokines and growth factors, which act in a paracrine and endocrine manner to facilitate healing of damaged tissue by stimulating the body’s own regenerative mechanisms.
Further information about the mechanism of action of PLX cells is available under Science and Technology in this website
For further information regarding the placenta, please click here.
PLX-PAD cells exhibit regenerative potential due to their capacity to release factors in response to chemical distress signals from tissues that have been damaged by muscle trauma or inflammation. These therapeutic factors trigger the body’s repair mechanisms and stimulate tissue renewal, differentiation and modulation of immune-mediated inflammation. PLX-PAD cells also modulate the immune system, which plays a central role in the body’s response to injuries.
PLX-PAD is currently in a Phase III multinational clinical trial in muscle recovery following surgery for hip fracture. In addition, an investigator-initiated Phase I/II trial is being conducted with PLX-PAD by Tel Aviv Sourasky Medical Center (Ichilov Hospital) for the treatment of steroid-refractory chronic graft versus host disease (cGvHD)
PLX-R18 cells release a combination of therapeutic proteins in response to a damaged or poorly functioning hematopoietic system; this system creates the blood cells that protect us from infection, uncontrolled bleeding and anemia.
PLX-R18 demonstrated positive results in a Phase I clinical trial to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) and it is in development to treat Acute Radiation Syndrome (ARS).
PLX-R18 cell therapy was granted an orphan drug designation by the FDA for the treatment of graft failure, incomplete hematopoietic recovery following HCT and ARS. The Orphan Drug Act provides for granting special status to a drug or biological product, to treat a rare disease or condition. The benefits of achieving Orphan Drug Designation include close guidance by the FDA, which may accelerate the path to potential marketing approval, orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.
The FDA has also cleared Pluristem’s Investigational New Drug (IND) application for PLX-R18 in the treatment of ARS. The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.
PLX-R18 is also being evaluated in preclinical studies to explore its therapeutic potential to treat a variety of other hematologic indications.
PLX-Immune are cells that have been induced with tumor necrosis factor alpha (TNF-a) and interferon-gamma (IFN-g), to transiently alter their secretion profile.
The product has been evaluated in pre-clinical studies and a peer-reviewed article in the journal Scientific Reports, from Nature, was published which examined the effect of the cells in over 50 lines of human cancerous cells. The results showed that PLX-Immune cells exhibited an anti-proliferative effect on 45 percent of the tested cancer cell lines, with a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers. Comprehensive bioinformatics analysis identified common characteristics of the cancer cell lines inhibited by PLX cells. This knowledge could potentially be used in the future for screening patients’ tumors to identify those patients most likely to show a positive response to treatment with PLX cells.
An additional pre-clinical study of female mice harboring human triple negative breast cancer (TNBC) showed that weekly intramuscular (IM) injections of the cells produced a statistically significant reduction (p= 0.025) in mean tumor size in the treated group compared with the untreated group, with 30 percent of the treated mice exhibiting complete tumor remission. In addition, a statistically significant reduction (p=0.003) was seen in the percentage of proliferating tumor cells as well as in the level of blood vessels within the tumors.
Our vision is to make PLX cell treatments available to patients all over the world. For more information on our clinical development strategy, please click here.