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NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways
TORONTO and HAIFA, Israel, Dec. 12, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (...
About this update from Nurexone Biologic Inc
[{"type":"text","content":"NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE PathwaysSupported by Scientific Evidence Showing Tissue Repair Quality of Company’s Exosomes\n\n\n\n TORONTO and HAIFA, Israel, Dec. 12, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“\n \n NurExone\n \n ” or the “\n \n Company\n \n ”), a preclinical-biotechnology company developing exosome-based therapies for central nervous system injuries, today announced meaningful progress in its long-term clinical-readiness strategy. The Company has begun the process of evaluating potential Israeli production partners to support small-scale GMP-based manufacturing of its lead candidate, ExoPTEN, in order to test the drug in under a First-in-Human Use program, pending regulatory approval.\n \n\n Dr. Lior Shaltiel, Chief Executive Officer, noted: “ExoPTEN brings together a powerful synergistic impact with highly active exosomes produced, combined with a targeted siRNA. As we advance our manufacturing plans, small clinical grade batches will position us to prepare a First-in-Human use submission in the future, if and when the regulatory pathway supports it.” He added, “ExoPTEN is being developed for both acute spinal cord injury and optic nerve injury, although it has not yet been determined which indication will be prioritized for a first-in-human program.”\n \n\n In parallel, NurExone reported new scientific data showing strong biological activity in its exosomes compared with commercially available exosomes, reinforcing confidence in the platform as the Company advances toward human studies.\n \n\n\n Early Manufacturing in Israel: A Key Step Toward U.S. Scale-Up\n \n\n\n NurExone is currently evaluating several Israeli manufacturing organizations with expertise in advanced biologics and Good Manufacturing Practices (“\n \n GMP\n \n ”)-aligned systems for small-scale ExoPTEN manufacturing runs aligned with future clinical requirements.\n \n\n “This is a strategically important next phase of operational de-risking,” said Dr. Ina Sarel, Head of CMC, Quality and Regulatory Affairs. “Israel is the starting point for our small scale GMP-production of exosomes and process validation, after which exosome pr...