Kolon Life Science Inc. announced on Sept. 23 that the U.S. Food and Drug Administration (FDA) maintained its order to suspend patient enrollment for clinical trials on Kolon TissueGene’s gene osteoarthritis drug Invossa, whose permit as Korea’s first gene therapy drug had been revoked by the Korean government for mislabeling and false reporting of ingredients.
The company disclosed that it was asked of additional information from the FDA, including cell characteristics and genetic analysis, to resume clinical trials on Invossa. It said that it can submit the information requested by the FDA.
The required data includes chondrocytes traits data from Invosa’s first fluid, data analysis of gag and pol gene sequencing of the second fluid, and confirmation of retrovirus generation after the introduction of env genes into the second fluid cells before and after irradiation.
A Kolon TissueGene official said, “We can provide additional data requested by the FDA fully through additional experiments in the future.”
The FDA had asked for a detailed analysis of the drug makeup as well as a full account of the mix-up and corrective action plans on May 3. The FDA letter was a reply to Kolon TissueGene’s submission of data as previously required by the U.S. regulator on Aug. 23.
The company official said, “We will continue our efforts to resume the phase-3 trial on Invossa as soon as possible by supplementing data.”
In addition, the FDA has recommended the company to re-manufacture the second fluid (TC) using the first fluid (HC) to make a better drug.
The license for Invossa was issued by the Korean Ministry of Food and Drug Safety in 2017 as the country's first gene therapy drug. However, the drug authorities canceled the approval of Invossa for the false reporting of its ingredient after they confirmed that the ingredient used in Invossa stemmed from a kidney cell, not from cartilage. The kidney cell is known to have the danger of causing cancer. The phase-3 trial on Invossa in the United States has also been suspended.