GC Green Cross reiterated its position to derive the results of a phase 2a clinical trial in March and apply for conditional permission around April for the new coronavirus infection (Corona 19) plasma treatment’GC5131A’, which is currently being developed.
At the discussion on’Conversation with the Future: The Road to a Clean Country for Corona 19′ debate held at the National Assembly on the 12th, GC Green Cross development headquarter Lee Jae-woo said, “It is expected that it will end at the end of this month. The analysis is expected to come in March,” he said. “Assuming that this result is good, we plan to apply for conditional permission to the Ministry of Food and Drug Safety around April.”
In this regard, GC Green Cross reaffirmed its plan to apply for conditional approval in April, saying, “It is correct that data is being derived to terminate clinical trials within the first quarter,” in a call with this magazine.
This means that it is 3 to 4 months behind the schedule announced by GC Green Cross, and in fact, it is difficult to apply for conditional permission within the first quarter. Last year, GC Green Cross announced its position several times that it would apply for conditional permission by drawing the results of phase 2 by the end of the year.
Green Cross, which started its first patient medication on September 19 last year, is known to have had difficulty recruiting patients after entering clinical trials. In November of last year, the number of clinical trials was expanded from 6 to 12. It is reported that GC Green Cross completed patient recruitment in December of last year and completed patient medication earlier this month.
As a result, GC Green Cross finally recruited 64 patients. The original plan was 60 people. According to the GC Green Cross, this phase 2a is to select an appropriate dose and to confirm the safety and effectiveness.Pneumonia patients and high-risk patients (70 years of age or older, or 60 years of age or older with at least one underlying disease) It is the target.
In addition, Green Cross is in the position that it is applying for conditional permission based on the results of Phase 2a without additional enforcement of Phase 2b. Some pointed out that it is necessary to proceed with phase 2b due to the lack of number of recruited patients in phase 2a.
In response, GC Green Cross explained that it was originally planned to apply for conditional permission after the second phase of the state project.
An official from GC Green Cross said, “The national project that GC Green Cross has been competing for is from the completion of Phase 2a, which is currently in progress, until application for conditional permission.” “We are carrying out the project as planned.”
However, this official said, “The process after that will require discussion with the government.”
GC Green Cross was selected as a candidate for the government’s national project in May and is developing GC5131A with the National Institute of Health.
Accordingly, the results of Phase 2a, which will be drawn in March, are expected to become a watershed in the speed of development of medical treatment sites and blood system drugs in the future.
On the other hand, on the 15th, Ulsan University Hospital applied for approval for therapeutic use of GC5131. This is the 31st application for approval for therapeutic use for GC5131A.
The approval for therapeutic use is a system in which pharmaceuticals undergoing clinical trials are approved for use by the Ministry of Food and Drug Safety for the treatment of emergency patients who are in danger of life or do not have alternative treatment means.