PLacental eXpanded (PLX) cells are placenta-derived, mesenchymal-like adherent stromal cells that 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 or endocrine manner to facilitate healing of damaged tissue by stimulating the body’s own regenerative mechanisms.
More about the mechanism of action of the cells is available under Science and Technology in this website.
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PLX-PAD cells respond to chemical distress signals from tissues that have been damaged by ischemia (inadequate blood flow), muscle trauma, or inflammation, by secreting a range of therapeutic proteins that trigger the body’s own repair mechanisms. These secreted proteins drive the body to grow collateral blood vessels to bring oxygenated blood to ischemic tissue, heal damaged muscle, and dampen inflammation. PLX-PAD cells also modulate the immune system, which plays a central role in the body’s response to injuries.
PLX-PAD is being developed in clinical trials for Critical Limb Ischemia via accelerated regulatory pathways in both Europe and Japan. Pre-marketing “pivotal” trials are ongoing in both regions. Two completed Phase I trials of PLX-PAD in Critical Limb Ischemia produced positive results, and a randomized, double-blind Phase II study has demonstrated the safety and potential efficacy of PLX-PAD in treating muscle injury in the context of hip replacement surgery. The cells are also being studied in an ongoing Phase II trial in Intermittent Claudication, and are being evaluated for other indications including Preeclampsia.
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. The product is currently in development to treat incomplete engraftment of transplanted hematopoietic cells and Acute Radiation Syndrome (ARS).
The U.S. National Institutes of Health’s NIAID is initiating dose evaluation studies of PLX-R18 in ARS as a basis for a potential pre-marketing trial in a large animal model. Positive data from that trial could allow Pluristem to apply for approval of PLX-R18 in this indication using the Animal Rule regulatory pathway. 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 had 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, published in a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, 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% 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% 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.