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제목 CTA approval for Phase 1 in UK
작성자 관리자 작성일 2018.05.30 조회수 817
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OliX Pharmaceuticals receives Clinical Trial Authorization in the UK to initiate Phase I study with OLX10010, an anti-scar RNAi therapeutics


SUWON, South Korea, May 29, 2018 /PRNewswire/ -- OliX Pharmaceuticals Inc., a leading developer of RNA interference (RNAi) therapeutics (CEO: Dong-ki Lee, Ph.D.), announced that it received the Phase I clinical trial authorization (CTA) with its anti-scar drug, OLX10010, from Medicines and Healthcare products Regulatory Agency (MHRA) in the UK as of May 11, 2018. "The approval of this CTA marks an important milestone for OliX's RNAi therapeutic development, by demonstrating that OliX has met and qualified against the high standards of a European regulatory agency" noted Dong-ki Lee, CEO of OliX. The detailed information on the trial has been posted in ISRCTN registry which is a global clinical trial registry.


Hypertrophic scar, the main indication of OLX10010, results from the over-growth of dense fibrous tissue that can develop during the wound healing process after a skin injury or surgery, which may cause functional impairment and cosmetic disfigurement. It is reported that approximately one-third of post-operative patients develop a hypertrophic scar within 12 months. Given the unmet medical needs with no FDA- approved drug, OLX10010 could be a promising therapeutic option for these patients.


Phase I study of OLX10010 in Korea was conducted by Hugel Inc., OliX's co-developer and exclusive distributor in Asia, and completed without any serious adverse events. Covance, a global contract research organization and drug development services company, will conduct the Phase I trial in their specialized clinic, which is expected to be finished by the first half of 2019.


OliX Pharmaceuticals, Inc.


OliX is a clinical stage pharmaceutical company developing therapeutics against a variety of disorders by down-regulating expression of disease-causing genes, based on its own proprietary RNAi technology. The company is currently developing novel therapeutic programs for treatment of various diseases with high unmet medical needs, including hypertrophic scar, dry form of age-related macular degeneration (AMD), subretinal fibrosis, idiopathic pulmonary fibrosis (IPF).


 

https://www.prnewswire.com/news-releases/olix-pharmaceuticals-receives-clinical-trial-authorization-in-the-uk-to-initiate-phase-i-study-with-olx10010-an-anti-scar-rnai-therapeutics-300655610.html