Time to encourage Kolon to proceed with clinical trial
Kolon Life Science has received approval from the U.S. Food and Drug Administration (FDA) to resume Phase 3 clinical trial of Invossa-K, a gene therapy drug for osteoarthritis. The FDA recently sent an official notice to Kolon TissueGene, the company's U.S. subsidiary, stating that the clinical hold on the trial was being withdrawn as issues regarding this had been resolved and so the firm could continue with the Invossa Phase 3 clinical trial.
The FDA decision has given Kolon Life Science a fresh start on the clinical trial in the U.S., 11 months after it was suspended last May. The trial was halted after Invossa's cell line was found to have been mislabeled as cartilage-derived, when the company had actually been using kidney-derived cells. Korea's Ministry of Food and Drug Safety revoked the medicine's license in July and the Korea Exchange is in the process of delisting Kolon TissueGene from the KOSDAQ bourse. Kolon Life Science CEO Lee Woo-seok was indicted for violating the Pharmaceutical Affairs Act.
Kolon Life Science said the resumption of the clinical trial means the FDA has acknowledged the efficacy of previous trial data submitted by the company, paving the way for it to continue injecting patients with kidney-derived cells. In retrospect, our drug regulator should have been more cool-headed in dealing with the Invossa scandal until the FDA had made a decision.
Kolon TissueGene plans to proceed with Invossa's Phase 3 trial in the U.S. after completing supplementary procedures. But the FDA decision does not necessarily mean that it will be successful, given that even top biopharmaceutical companies seldom achieve immediate success in developing new drugs. Biotech is one of the country's new growth engines that could bolster Korea Inc. and so it's necessary to let Kolon get to the end of its difficult and time-consuming drug development. Certainly, now is the time to encourage Kolon.
Kolon Life Science has received approval from the U.S. Food and Drug Administration (FDA) to resume Phase 3 clinical trial of Invossa-K, a gene therapy drug for osteoarthritis. The FDA recently sent an official notice to Kolon TissueGene, the company's U.S. subsidiary, stating that the clinical hold on the trial was being withdrawn as issues regarding this had been resolved and so the firm could continue with the Invossa Phase 3 clinical trial.
The FDA decision has given Kolon Life Science a fresh start on the clinical trial in the U.S., 11 months after it was suspended last May. The trial was halted after Invossa's cell line was found to have been mislabeled as cartilage-derived, when the company had actually been using kidney-derived cells. Korea's Ministry of Food and Drug Safety revoked the medicine's license in July and the Korea Exchange is in the process of delisting Kolon TissueGene from the KOSDAQ bourse. Kolon Life Science CEO Lee Woo-seok was indicted for violating the Pharmaceutical Affairs Act.
Kolon Life Science said the resumption of the clinical trial means the FDA has acknowledged the efficacy of previous trial data submitted by the company, paving the way for it to continue injecting patients with kidney-derived cells. In retrospect, our drug regulator should have been more cool-headed in dealing with the Invossa scandal until the FDA had made a decision.
Kolon TissueGene plans to proceed with Invossa's Phase 3 trial in the U.S. after completing supplementary procedures. But the FDA decision does not necessarily mean that it will be successful, given that even top biopharmaceutical companies seldom achieve immediate success in developing new drugs. Biotech is one of the country's new growth engines that could bolster Korea Inc. and so it's necessary to let Kolon get to the end of its difficult and time-consuming drug development. Certainly, now is the time to encourage Kolon.
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