GC Pharma starts Phase 2 trials of Covid-19 plasma treatment
The first patient was injected with the plasma treatment GC5131A on Saturday at Chung-Ang University Hospital in southern Seoul. Plasma treatments are made from immune proteins extracted from blood plasma donated by people who have had the virus.
One of the two government partners to develop a coronavirus treatment, GC Pharma received a nod to undergo Phase 2 clinical trials on Aug. 20. It was permitted to skip Phase 1 clinical trials, as the safety of plasma treatment had been approved in other commercialized drugs.
The Phase 2 trials will be conducted on 60 coronavirus patients that are showing symptoms of pneumonia or are in a vulnerable state such as old age or were battling other diseases before infection. It is aimed to verify the safety and efficacy and explore the right dosage to treat the respiratory illness. Six hospitals including Chung-Ang will take part.
GC Pharma’s head of development Lee Jae-woo said in a conference early September that the aim is to complete injections of GC5131A for Phase 2 clinical trials within this year. A core variant that decides the progress of developing a plasma treatment is blood donations. It normally takes plasma donated by two to three recovered patients to develop a plasma treatment for a single patient.
As of Sept. 5, more than 2,600 recovered patients had offered to donate blood. Forty-six centers run by the Korean Red Cross Blood Services nationwide will collect the donated blood.
The CoVIg-19 Plasma Alliance is also planning to launch Phase 3 clinical trials for a plasma treatment. GC Pharma is one of the 10 members of this alliance working together in a global initiative to find a plasma-based Covid-19 treatment. The alliance’s jointly-developed treatment candidate will conduct Phase 3 trials on 500 Covid-19 patients in the United States, Denmark, Argentina and Britain.
BY SONG KYOUNG-SON [firstname.lastname@example.org]