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HAIFA, Israel, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it is assessing its readiness to initiate mass production of PLX-R18, a novel potential treatment for hematopoietic complications of the acute radiation syndrome (H-ARS) following exposure to nuclear radiation, in response to heightened global tensions and escalating nuclear threats, particularly in Ukraine.
PLX-R18 has shown potential promise in significantly improving survival and accelerating recovery from H-ARS in preclinical animal and human studies, conducted with support from leading global health and U.S. defense agencies. PLX-R18 demonstrated the ability to stimulate blood cell regeneration and potentially mitigate the effects of radiation exposure.
H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, anemia, and possibly death. The U.S. Food and Drug Administration (“FDA”) previously approved an Investigational New Drug application for PLX-R18 for the treatment of H-ARS in the case of nuclear or radiological or incidents and granted it Orphan Drug Designation.
Scaling Up Production
Beyond what is required for ongoing clinical studies, the Company is actively examining the steps required to ramp up production in the event of increased and urgent global demand. Pluri’s state-of-the-art manufacturing facility is designed to handle large-scale production of cellular therapies and could be mobilized to scale up to mass production, if necessary.
“At Pluri, we stand ready to support communities in need by leveraging our expertise to respond to global emergencies,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “That is why we are evaluating our readiness to scale production if global circumstances escalate and demand arises. We believe that our proactive approach will ensure global preparedness.”
About Pluri
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).