SOLUTIONS
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 rebalance the immune system, which
plays a central role in the body’s exacerbated and
uncontrolled attack on its own cells and organs
in autoimmune diseases.
Pluri completed a global Phase III study of
PLX-PAD to treat muscle recovery following
surgery for hip fracture. Pluri is part of an
international consortium led by Charité Berlin,
which plans to begin an investigator-initiated
Phase I/II trial to study PLX-PAD for the treatment of Osteoarthritis (OA) during 2023, funded by the
EU Horizon Europe program. 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, which plays a key role in protection from infection, uncontrolled bleeding and anemia.
PLX-R18 cells release a combination of therapeutic proteins in response to a
damaged or poorly functioning hematopoietic system, which plays a key role in
protection from infection, uncontrolled bleeding and anemia.
PLX-R18 is the first product candidate to successfully use technology to
induce PLX cells with different cytokines to alter their secretion profile prior to
administration. A first in human study to evaluate the safety and exploratory
efficacy of intramuscular injections of PLX-R18 in subjects with incomplete
hematopoietic recovery following HCT received positive results.
PLX-R18 cell therapy was granted an orphan drug designation by the FDA for the treatment of graft failure, incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) and Acute Radiation Syndrome (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.
Several studies were conducted via the FDA animal rule pathway in order
to evaluate PLX-R18 as a medical countermeasure for the treatment of the
hematopoietic Acute Radiation Syndrome (ARS), and as a potential prophylactic countermeasure against ARS. The FDA has cleared Pluri’s Investigational New
Drug (IND) application for PLX-R18 in the treatment of ARS. The IND allows Pluri to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.
Extracellular vehicles (EVs)
· Cell-based Exosomes -small membrane vehicles, secreted by cells cultured in our 3D, state-of-the-art GMP controlled facility
EV’s serve as diagnostic tool, substance delivery vehicle and potentially direct disease treatment
Secretome in media
Our novel technology and platform design support vast secretion of proteins, growth factors and antioxidants, naturally secreted to the growth medium during the production of the cells
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