TOKYO, May 01 (Pulse News Wire) – Kringle Pharma,inc. (4884.T) concluded a face-to-face consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding its planned additional clinical trial for KP-100IT, a recombinant human hepatocyte growth factor protein aimed at acute spinal injury patients.
Following the completion of Phase III trials, the company agreed on the framework for the additional trials, which are set to begin early. Specific details of the trial will be disclosed once the final review process is completed. Spinal injuries affect approximately 6,000 people annually in Japan, leading to severe disabilities such as paralysis and bladder dysfunction in many cases. The condition affects around 100,000 to 200,000 individuals nationwide, according to various studies cited by the company.
Hepatocyte Growth Factor (HGF) has shown promise in treating spinal injuries due to its neuroprotective properties and ability to promote axonal regeneration. Research conducted by Professor Eiji Okano and others at Keio University's Regenerative Medicine Research Center demonstrated its potential efficacy in addressing spinal injuries. Additionally, HGF’s therapeutic effects on Amyotrophic Lateral Sclerosis (ALS) have been highlighted through research led by Professor Masashi Aoki at Tohoku University. Kringle Pharma aims to develop innovative treatments for difficult diseases and contribute to society by advancing the development of HGF-based therapies.
Currently, the company is progressing with late-stage pipeline developments targeting acute spinal injuries and vocal cord scars, with plans for further expansion into fibrotic conditions.
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