TOKYO, Jul 03 (Pulse News Wire) – Kringle Pharma,inc. (4884.T) announced the completion of a review by the Pharmaceuticals and Medical Devices Agency (PMDA) for its Phase III supplementary clinical trial involving recombinant human hepatocyte growth factor (HGF) protein Oremerpermin Alpha in acute spinal cord injury patients.
Following this approval, the company plans to swiftly commence the trial across three domestic facilities, targeting ten cases from July 2026 to June 2028. The trial involves administering Oremerpermin Alpha at 0.6 mg/body once weekly for five doses intrathecally. Eligible patients must meet specific criteria, such as being aged 18 to 89 and having cervical spine injuries classified as AIS A within 72 hours post-injury. Patients with severe trauma, ongoing steroid therapy, or malignancies are excluded.
Key outcomes will focus on the proportion of patients showing improvement to AIS C or higher six months after treatment. Detailed information about the study will be available soon through registries managed by the Ministry of Health, Labour and Welfare's Clinical Research Submission System (jRCT) and the National Institutes of Health’s ClinicalTrials.gov. Spinal cord injuries affect approximately 10,000 people annually in Japan, leading to significant long-term disabilities. HGF, known for its neuroprotective properties, holds promise in treating various neurological disorders, including ALS and vocal cord scarring.
Kringle Pharma continues to advance HGF research aimed at providing innovative treatments for difficult-to-treat diseases.
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