Kolon TissueGene will temporarily suspend the third phase of U.S. clinical trial for the osteoarthritis cell gene therapy called Invossa. Because the solution used in the product is different from the original licensed ingredient, the company plans to withhold the ongoing recruitment of patients and check safety first.
Kolon TissueGene said on April 1 that it had reached an agreement with the U.S. Food and Drug Administration to temporarily suspend the collection of patients after it was found that one of the two components of Invossa came from 293 derived cells.
Originally, it was thought that the solution was used as a cartilage-derived cell according to the Korean permit, but it was confirmed belatedly that the other 293 cells were used.
Invossa is a gene therapy drug that injects 1HC and 2 TCs, which are extracted from a person's cartilage, into the joint cavity at a ratio of 3:1. In South Korea, Kolon Life Science sells the product under the name of "Invossa K."
South Korea's Ministry of Food and Drug Safety has requested Kolon Life Science to stop manufacturing and selling the Invossa K as one of the product's main ingredients is believed to be kidney-specific cells different from the same cartilage cells listed in the data submitted at the time of approval.
As a result, Kolon Life Science will voluntarily stop distribution and sales of Invossa from next month to check its safety.
"We have been using 293 derived cells as transformed cells until the completion of full-time phase, clinical phase 1 and phase 2," said Kolon TissueGene. "We believe that there will be no impact on the safety and effectiveness of products."