TORONTO and HAIFA, Israel, March 14, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) is pleased to announce that it has successfully completed an important preclinical study towards its Investigational New Drug (“IND”) submission. The new study, which
advances the Company’s path towards first-in-human trials, demonstrated that ExoPTEN treatment with different dose regimens led to both motor function recovery and significant improvements in blood flow at the site of spinal cord injury—an essential factor in tissue healing and functional recovery.i“This preclinical study evaluated dosing regimens to provide efficacy data in support of our IND submission,” said Dr. Tali Kizhner, Director of R&D at NurExone. “The results reinforce ExoPTEN’s potential to enhance the body’s natural repair mechanisms following spinal cord injury. Notably, the increased blood vessel size observed in treated subjects indicated improved circulation, which is crucial for oxygen and nutrient delivery to damaged tissues. These findings suggest that ExoPTEN has the potential to become a transformative therapeutic candidate, and we are eager to advance toward clinical trials.”
Scientific publications and reach in the field have shown already that post-injury angiogenesis and vascular remodeling correlate with improved functional recovery in spinal cord injury models.ii
The study compared two dosing regimens of ExoPTEN: a single high dose on the day of surgery versus a lower dose administered over five consecutive days. Both treatment groups showed significant improvements in motor function recovery compared to the control group, as measured by the modified Basso, Beattie, and Bresnahan (“BBB”) locomotor rating scale (Figure 1A). Additionally, histological analysis revealed that ExoPTEN treatment significantly increased the average blood vessel size (Figure 1B-1C), suggesting improved circulationi - a critical factor in post-injury healing and functional restoration.
NurExone will continue to refine ExoPTEN’s therapeutic profile as part of its ongoing preclinical program, paving the way to IND submission and regulatory approval for first-in-human trials.
About NurExone
NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”), OTCQB and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsiii. Regulatory milestones, including Orphan Drug Designation, facilitate the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
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