Kolon Life Science Inc. has voluntarily suspended sales of Invossa-K Inj. (gene therapy), a degenerative arthritis treatment, as a cell line different from the one permitted by the Ministry of Food and Drug Safety (MFDS) has been discovered.
The MFDS requested that Kolon Life Science discontinue manufacturing and sales of Invossa-K Inj. because one of the main components (Solution 2) of the treatment is presumed to be a cell line different from the one described in the document previously submitted for approval.
Kolon Life Science received approval from the United States on its Phase 3 clinical trial plan for the product and reported to the Korean MFDS that it has found that the cell of Solution 2, which is used as an adjunct to assist the growth of cartilage cells contained in Solution I, is different from the one described in the data submitted for approval.
The MFDS banned doctors from prescribing this treatment. Currently, the product is distributed to 443 hospitals and clinics.
Invossa-K Inj. is a gene therapy agent used for the treatment of moderate knee osteoarthritis. It consists of Solution 1 of homologous chondrocytes and Solution 2 of TGF-β1 gene-insertion homologous chondrocytes. The second solution is administered together to aid the growth of cartilage cell in Solution 1 and die after a certain period of time (two weeks).
Initially, the approval was given to Solution 2 for gene containing chondrocytes. However, in the distributed products, a kidney cell line for production of gene delivery medium was included.
Kolon Life Science said, "TGF-β1 gene (a factor promoting cell proliferation) to be inserted into cartilage cells in the production of Solution 2 is produced using kidney cells (GP2-293). Then, the TGF-β1 gene is separated and purified from the kidney cells and inserted into chondrocytes, and some of the kidney cells were mixed in this process due to incomplete separation and purification..
Ddistribution and sales of the gene therapy have been banned because the cells used in Korea are likely to be the same as the cells used in the United States. The test results on cells used in Korea will be released around March 15.