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.
For illustration of the cell’s mechanism of action please press here.
More about the mechanism of action of the cells is available under Science and Technology in this website.
For further information regarding the Placenta press here.
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. Pluristem has been granted FDA Fast Track Approval and was accepted to the FDA Expanded Access Program, EMA Adaptive Regulatory Pathway and PMDA Accelerated Regulatory Pathway.
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. Positive results were also seen in a completed Phase II trial in Intermittent Claudication.
Reed more about PLX-PAD in the Treatment of- CLI, IC, Orthopedic indications, Pulmonary Arterial Hypertension, Women’s Health. (Press each indication)
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 recovery of transplanted hematopoietic cells and Acute Radiation Syndrome (ARS).
PLX-R18 cell therapy was granted an orphan drug designation by the FDA for the treatment of 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.
Read more about PLX-R18 in the treatment for recovery of the Hematological System and ARS- Acute Radiation Syndrome.
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.
In order to provide treatments using PLX cells all over the world, we are working according to a clinical development strategy. For more information press here.
PARTNERS AND COLLABORATION Home > Partners and collaboration
Pluristem has a collaboration with NASA’s Ames Research Center to evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions. Dr. Ruth Globus of NASA’s Ames Research Center, in California’s Silicon Valley, has been awarded a 2019 NASA Ames Research Innovation Award (ARIA) for the collaboration with Pluristem. The project, titled, “Therapeutic Stromal Cells for Health in Space,” has been selected to preclinically evaluate the potential of Pluristem’s PLX cell therapies in preventing and treating medical conditions caused during space missions, including indications relating to blood, bone, muscle, brain and heart.
U.S. National Institutes of Health (NIAID)
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), conducted studies in large animals to evaluate dosing for PLX-R18 as a medical counter measure in the treatment of the hematologic component of Acute Radiation Syndrome (ARS). After determining optimal dose in large animals, the next step is to conduct a study, strategically designed to demonstrate the superiority of PLX-R18 versus current standards of care, with the goal of executing a full contract once the study is completed.
The results used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. The NIAID is supporting and collaborating on the dosing studies, and previously supported and completed two preclinical studies of PLX-R18 as a potential treatment for the hematologic syndrome of ARS, with those studies showing a substantial and statistically significant increase in the survival of irradiated rodents treated with PLX-R18 versus placebo, and revealing the underlying mechanism of action of our cells in this indication.
U.S. Department of Defense (DOD)
Pilot study of the Pluristem’s PLX-R18 cell therapy was initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study is examining the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to exposure to radiation.
A license agreement with a subsidiary of Chart Industries, Inc. is regarding Pluristem’s thawing device for cell-based therapies. Per the terms of the agreement, Chart obtains the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding China, with Pluristem receiving royalties from sales of the product and supply of an agreed number of devices. Pluristem’s point-of-care thawing device technology is designed to allow for the precise and automated thawing of cells in a controlled and monitored environment, and is expected to result in the highest levels of cell viability and quality. The technology includes many advanced unique proprietary features which were designed to result in the leading thawing devices on the market.
Thermo Fisher Scientific
A strategic collaboration with Thermo Fisher Scientific was signed to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain. The collaboration combines Thermo Fisher’s experience in cell therapy development and bioproduction scaleup with Pluristem’s expertise in cell therapy manufacturing, clinical development and quality control. Together, the companies hope to transform cell therapy manufacturing into a large-scale, high capacity industry that will enable the production of millions of therapeutic doses of regenerative medicines. Currently, over 850 companies worldwide are developing regenerative medicine and advanced therapies. There are more than 900 clinical trials underway, with several approved and marketed products worldwide. This sector holds the promise of addressing many unmet medical needs, but requires a change in the supply chain of equipment, consumables, reagents and storage systems to enable the treatment of millions of patients.
Pluristem has an exclusive out-license and strategic partnership agreement with Cha Biotech (Kosdaq:CHA) for the development and use of PLX-PAD in Critical Limb Ischemia (CLI), and Intermediate Claudication (IC), with rights exclusively in South Korea. Cha Biotech will perform and fund clinical trials in South Korea under the supervision of the Korea Food & Drug Administration (KFDA). Upon a regulatory approval for a PLX product in South Korea, Pluristem and Cha have agreed to establish a joint venture (JV) co-owned by the parties to commercialize PLX cell products in South Korea.
Pluristem have been privileged to conduct studies of PLX cells in collaboration with renowned researchers at internationally recognized institutions. For further information click here.