Kringle Pharma, Inc. Announces Initiation of Phase III Study of HGF in Vocal Fold Scar
November 23, 2022 at 11:30 pm EST
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Kringle Pharma, Inc. announced the start of Phase III, a placebo-controlled, double-blind clinical study, to confirm the efficacy and safety of recombinant human HGF (KP-100LI) administered in patients with vocal fold scar. KRINGLE aims to develop and commercialize HGF as an innovative therapeutic agent for various fibrotic diseases, focusing on vocal fold scar as the initial target indication. KRINGLE already submitted a Phase III clinical trial application to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, as announced by the KRINGLE news release dated October 24, 2022. Since then, the review process by PMDA was completed and the regulatory clearance was obtained to initiate the Phase III study. KRINGLE and Kyoto Prefectural Public University Corporation (Chairman: Akihiro Kinda) have signed a clinical trial agreement for the Phase III study, and University Hospital, Kyoto Prefectural University of Medicine, is ready to enroll patients in this study. The Phase III study will be conducted at five clinical sites in Japan including University Hospital, Kyoto Prefectural University of Medicine. Each clinical site will begin screening patients subsequently once contracts and other preparations are all set. The Phase III study has been supported by the Japan Agency for Medical Research and Development
(AMED) as its CiCLE program (Project title: Clinical development of recombinant HGF protein for the
treatment of refractory fibrosis).
Kringle Pharma Inc is a Japan-based company mainly engaged in the development of pharmaceuticals. The Company is involved in the research and development of therapeutic agents for intractable diseases using hepatocyte growth factor (HGF) protein. HGF has versatile bioactivity that is responsible for tissue or organ regeneration and protection such as cell proliferation promotion, cell motility promotion, anti-apoptosis, morphogenesis induction, and angiogenesis. HGF has a therapeutic effect on chronic fibrotic diseases such as liver cirrhosis, chronic renal failure, pulmonary fibrosis and cardiomyopathy. HGFs target diseases are Atrophic lateral sclerosis (ALS), Acute renal impairment, Vocal scar and others. The Company is involved in the general new drug development processes such as basic research, non-clinical trials and manufacturing, clinical trials, approval application and authorization, marketing and expansion of indications.
KRINGLE PHARMA, INC. 
