Kolon Life Science has confirmed cancerous cell lines in Invossa-K, a degenerative arthritis treatment the sales of which was suspended by the company, through an interim analysis result of the drug.
|Kolon Life Science’s Invossa-K Inj., a treatment for degenerative arthritis|
“The company received the interim report on Monday and confirmed the same tumor-inducing cells found in the United States have also been identified in the treatments used in Korea,” a company official said to SBS, a local broadcaster. “The final report will be released on April 15.”
The confirmation came after Kolon Life Science admitted to having mislabeled GP2-293, which are abnormal cells transformed for unlimited proliferation like cancer cells. They are different from normal cells derived from the cartilage.
GP2-293 cells originate from human embryonic kidney 293 (HEK-293) cells commonly used for research. HEK-293 cells come from aborted fetal kidney cells. Unlike normal cells that die after a certain period, they can proliferate as quickly as cancer cells.
The vitality of HEK-293 cells is stronger than that of normal cells. In a research lab, HEK-293 cells are used to mass produce viruses, and the cells are discarded entirely because it is unpredictable what kind of mutations the cancerous cells could cause within the body when injected.
Invossa is composed of one liquid-component with only cartilage cells and second liquid-component with cartilage cells and growth factors, and the latter was found to have tumor-inducing cells.
“As both the U.S. and the local batch were made from one cell bank, the company expects that the final analysis will confirm that the two drugs consist of the same component,” the company said.
After the final report, the Ministry of Food and Drug Safety will decide whether to cancel Kolon Life Science’s sales license of the drug.
According to SBS, the ministry initially said that it would cancel the sales approval for Invossa. However, it has since taken an ambiguous stance, saying it may reverse the decision depending on whether the cell was initially different or changed mid-trial.
“It's hard to say for sure at the moment what our final decision will be,” said Kang Seok-hyun, director of the ministry’ Biopharmaceutical and Herbal Drug Division. “We should have a thorough review of the final results before concluding.”
If canceled, Kolon Life Science might also lose its export agreement for the treatment.
China Life Medical Centre, which is in charge of supply and regulatory approval of Invossa in Hainan, said that it is aware of the case and is consistently discussing the matter with Kolon Life Science.
However, the company added that they are not planning any immediate actions.
“We are waiting to hear the results from the Korean Ministry of Food and Drug Safety,” a company spokesperson told Korea Biomedical Review. “However, there are no concerns with our sales agreement with Kolon Life Science so far.”
It is not the right moment to give answers to the media, he added.
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