Policy & Regulation
Kolon Life Science receives approval to start clinical trials extending use of Invossa
23 November 2017 -

The Korean Ministry of Food and Drug Safety has granted Kolon Life Science (KOSDAQ: 102940) approval to begin clinical trials to prove its osteoarthritis drug Invossa can also be used as a treatment for more severe forms of the joint disease, the Korea Herald reported on Thursday.

The drug is currently approved in Korea as a treatment for patients with Kellgren & Lawrence grade 3 osteoarthritis, when a patient continues to experience pain after receiving pain-relief or physical therapy for over three months. When the condition worsens, it is raised to K&L grade 2, and Kolon Life Science wants to show that Invossa can also be used as a treatment for this diagnosis.

The Phase 3 clinical trials will involve 146 patients and will be conducted at 17 medical institutions in the country. The trials are planned to begin in January 2018 and will continue for two years.

Invossa is the world's first cell-mediated gene therapy to treat osteoarthritis of the knee. A single injection of the drug, which was developed by Kolon Group's US-based biopharma subsidiary TissueGene, was found to provide up to two years of therapeutic relief.

Korea's Drug Ministry approved Invossa in July for pain relief and function improvement, but not tissue regeneration. TissueGene aims to prove the drug's regenerative properties during Phase 3 clinical trials which are set to begin in the US next month. It hopes to commercialise Invossa in the US by 2023.