GC Pharma, a blood plasma-derived medicine company, said Monday that it has administered its COVID-19 plasma treatment GC5131A to the first domestic patient for a phase 2 clinical trial.
In Korea, professor Chung Jin-won of the division of infectious diseases at Chung-Ang University Hospital was the first to take on GC Pharma’s GC5131A pipeline for treatment of a COVID-19 patient on Saturday. This phase 2 trial will determine the right dosage for safe and efficacious use of GC5131A. It targets 60 seriously ill COVID-19 patients who are elderly, with pneumonia or underlying diseases, who are most vulnerable to the coronavirus, GC Pharma said.
It had taken the company a month since the Ministry of Food and Drug Safety approved its clinical design on Aug. 20, because it had taken time to secure and register the right candidates. GC Pharma is still seeking more candidates to fulfill the planned head count of 60, per its trial design.
Six medical institutions will carry out GC Pharma’s phase 2 trial: Chung-Ang University Hospital, Samsung Medical Center, Asan Medical Center, Korea University Ansan Hospital, Severance Hospital of Yonsei University and Chungnam National University Hospital.
Apart from Chungnam National University Hospital, which is located in Daejeon, they are based in Seoul.
All in all, GC Pharma anticipates to have the results from this phase 2 trial by year-end, and is simultaneously proceeding with the application of therapeutic use of the drug prior to final drug authorization.
GC Pharma is the only Korean company pursuing a plasma treatment for the SARS CoV-2 virus. This is not the same as directly injecting the blood of recovered patients to sick people seeking a chance immune response. GC Pharma separates plasma from the blood and fortifies the therapeutics agents in that yellow liquid into potent medicine.
In order to produce its plasma treatment, GC Pharma needs a continuous stream of blood plasma from recovered COVID-19 patients.
GC Pharma currently has enough GC5131A to carry out clinical phase 2 trials. The more plasma it has, the better, the company’s official said.
The company is asking those who have survived the coronavirus to give their blood by contacting plasma.gccorp.com or calling 080-260-8232, whereupon they will be redirected to one of the 46 appointed state-governed blood collecting agencies.
GC Pharma is providing the end product to COVID-19 patients at no cost domestically.
Overseas, the company is part of a global alliance called CoVIg-19 Plasma Alliance that is heading to phase 3 trials of a separate plasma treatment for 500 patients strewn across the US, UK, Denmark and Argentina. GC Pharma has contributed its insights from developing GC5131A to the alliance.
By Lim Jeong-yeo (email@example.com