TOKYO, Jun 19 (Pulse News Wire) – Kringle Pharma,inc. (4884.T) submitted a clinical trial application to the Pharmaceuticals and Medical Devices Agency (PMDA) for an additional Phase III study involving recombinant human hepatocyte growth factor protein (HGF) known as Oremerprmin Alfa (development code: KP-100IT).
The study targets patients suffering from acute spinal cord injuries. The company previously concluded Phase I/II trials and initial Phase III trials, analyzing their results to design a more effective follow-up study. By selecting cases with greater injury severity based on new criteria, Kringle Pharma aims to enhance efficacy rates. The firm plans to conduct further clinical trials to gather additional data on effectiveness before filing for marketing approval.
Spinal cord injuries affect approximately 10,000 people annually in Japan, with chronic patients bringing the total estimated number of sufferers to 100,000 to 200,000 individuals. HGF, discovered as a factor promoting liver cell proliferation, has shown promise in treating various conditions due to its multifaceted physiological activities, including neuroprotective effects and anti-fibrotic properties. Kringle Pharma's mission is to develop innovative treatments for rare diseases through research and development, aiming to contribute to society by providing groundbreaking therapeutic options for those afflicted with difficult-to-treat illnesses. The company is currently advancing late-stage development pipelines targeting acute spinal cord injuries and vocal cord scars.
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