Kolon Life Science’s “explanations” about the mislabeling of the cell ingredient of Invossa-K have been seemingly revealed as sheer lies. The company’s credibility plunged, and people even raise suspicion on its voluntary short tandem repeat (STR) testing.
The Ministry of Food and Drug Safety’s investigation results showed how unreasonable Kolon alleged that it never knew the cells in the second fluid of the osteoarthritis treatment were kidney-derived GP2-293 cells over a decade.
Kolon conducted polymerase chain reaction (PCR) tests on Invossa several times, which was enough to discover cancerous 293 cells, not cartilage-derived cells. However, the company submitted data that appeared to be cartilage cells selectively to the food and drug safety ministry.
To argue that the second fluid contained cartilage cells, Kolon compared the second fluid with a mixture of the first fluid and second, instead of the first fluid, in protein arrays testing. Then, the company falsely marked the mixture fluid as the first fluid.
Kolon applied for Invossa approval on July 7, 2016.
Even though the company was undoubtedly aware that the second fluid did not contain cartilage cells, it fabricated data as if it did.
Kolon was also aware that 293 cells were abnormal cells transduced for limitless proliferation, just like cancerous cells. However, it tried to cover this up by radiations. Mindful of 293 cells’ tumorigenicity, the company raised radiation dose by three grays from 56 grays, and Invossa’s efficacy fell further.
However, Kolon has continuously claimed that it “did not know” since the government suspended the sales of Invossa on March 31.
On May 3, Kolon TissueGene, a subsidiary of Kolon Life Science, said in a public filing that it was aware in March 2017 that the cell ingredient of the second fluid of Invossa was not cartilage-derived but kidney-derived cells (GP2-293 cells), as reported by contract manufacturer Lonza. However, its parent company “did not know because the issue was not reported to high ranking officials at TissueGene,” the company said.
However, the public filing turned out to be false because the food and drug ministry found that Kolon Life Science received a relevant e-mail from Kolon TissueGene, immediately after winning approval for Invossa in 2017.
The company’s allegation that it had conducted STR testing in February to check the cell ingredient voluntarily, not demanded by the U.S. Food and Drug Administration, is under suspicion, too.
Observers said it was not convincing that Kolon revealed the labeling error out of nowhere after hiding data on 293 cells all these years. The company must have been pushed by the FDA to conduct STR testing in February, they said.
Kolon Life Science and Kolon TissueGene are pinning hope on resuming phase-3 clinical trials in the U.S.
If the FDA grants Invossa trials despite the mislabeling, the food and drug safety ministry will take a step back from pressuring Kolon.
However, if the FDA takes issues with Kolon’s lack of compliance with Chemistry Manufacturing and Controls, it is unlikely that Kolon can resume the trials or win approval. CMC is the most essential part of the FDA's review of cell therapy.
<© Korea Biomedical Review, All rights reserved.>