Even though animal testing showed hamsters dying, vomiting blood, and suffering from severe lung enlargement, it has been confirmed that a COVID-19 treatment was actually administered to 93 patients after receiving clinical trial approval based on data that omitted these crucial findings.
This is the same treatment by Genexine (Genencell) that recently raised suspicions of lobbying, following revelations that Justice Minister nominee Kim Seung-won requested the Ministry of Food and Drug Safety (MFDS) to swiftly process its clinical trial approval.
According to data provided to the office of People Power Party lawmaker Yoon Sang-hyun by the MFDS, Genencell's COVID-19 treatment ES16001 was actually administered to 93 participants during Phase 2 clinical trials in South Korea in 2022.
This treatment was originally developed as a candidate substance for a shingles treatment.
To develop it as a COVID-19 treatment, Genencell conducted non-clinical trials in 2021 using hamsters infected with COVID-19.
However, one out of five hamsters in the high-dose administration group showed symptoms of drug reflux and vomiting blood before dying, and severe lung enlargement was observed even in the surviving subjects.
It was also reported that its efficacy as a treatment was not confirmed.
Nevertheless, these details were deleted or omitted from the report submitted by Genencell when it applied to the MFDS for Phase 2 clinical trial approval.
This was also confirmed in the first-instance ruling of the Pharmaceutical Affairs Act violation case involving Professor Kang, the founder of Genencell.
The court determined that Professor Kang ordered the deletion of the information to secure approval, knowing that the fact of the hamsters' deaths could unfavorably affect the clinical trial approval process.
The problem is that the MFDS did not immediately approve Genencell's clinical trial application at the time.
Genencell initially attempted to proceed directly to Phase 3 trials in South Korea based on Phase 2 trials previously conducted in India, but the MFDS rejected this and required them to reapply starting from Phase 2, while additionally requesting animal testing data and other documents.
While approval was being withheld during this process, investigations showed that Professor Kang asked nominee Kim Seung-won, who was a lawmaker at the time, for prompt approval through a broker surnamed Yang.
On October 12, 2021, nominee Kim asked then-MFDS Minister Kim Gang-lip, stating that Genencell had applied for clinical trials for a COVID-19 treatment and asking him to "take good care of it."
Fourteen days later, on October 26, the clinical trials were approved.
It has now been revealed that the approved treatment was not just limited to recruiting clinical trial participants, but was actually administered to 93 patients. Meanwhile, the MFDS stated that no serious and unexpected suspected adverse drug reactions were reported from these individuals.
(Reported by Kim Minjeong | Video by Ahn Jun-hyeok | Graphics by Yook Do-hyun | Produced by SBS Digital News)
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