NurExone Biologic Inc. announced that Professor Nahshon Knoller will present at the American Spinal Injury Association (ASIA) annual meeting. He will discuss NurExone’s planned 2026 Phase 1/2a clinical trial for ExoPTEN, a novel exosome-based therapy for acute spinal cord injuries (SCI), and share preclinical study results. This presentation marks the first public disclosure of NurExone’s clinical plans for ExoPTEN.
This announcement is crucial because it signifies NurExone’s transition from preclinical research to human trials, a major step towards potential commercialization of a new SCI therapy. Presenting at ASIA, a leading conference in the field, provides valuable exposure and validates the scientific rigor of ExoPTEN’s development. The planned trial design, including dose escalation and a placebo-controlled phase, demonstrates a commitment to establishing safety and efficacy. This progress is particularly important given the limited treatment options currently available for acute SCI.
The 2026 SCI Trial will enroll adult patients with traumatic SCI between spinal levels C5 and T10, classified as ASIA Grade A or B, within 3 to 7 days post-injury. ExoPTEN utilizes mesenchymal stem cell-derived exosomes loaded with siRNA targeting PTEN, a molecule that inhibits neural regeneration. Preclinical studies in rat models have shown promising results in motor, sensory, and structural recovery after complete spinal cord transection and compression. ExoPTEN has received Orphan Drug Designation from both the US FDA and the European Medicines Agency.
This announcement positions NurExone as a key player in the SCI treatment landscape. The initiation of human trials is a significant inflection point, paving the way for potential regulatory approval and eventual market entry. The data presented at ASIA will be critical for attracting further investment and collaborations, accelerating the development and potential impact of ExoPTEN. Success in the clinical trials could revolutionize SCI treatment and offer new hope for patients facing debilitating injuries.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
