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.
AstraZeneca's Fasenra misses primary endpoint in Phase III COPD trial
Hemogenyx reports positive safety and early efficacy data from third patient in CAR-T trial
Sanofi reports positive phase 2a results for brivekimig in hidradenitis suppurativa
GSK commits USD30bn to US R&D and manufacturing expansion
Neurocrine Biosciences announces presentation of Osavampator Phase 2 data at Psych Congress 2025
Ascletis presents ASC30 study results at EASD Annual Meeting
Three WuXi Biologics manufacturing facilities receive GMP certification from Turkish regulator
VarmX secures strategic collaboration and option agreement with CSL for novel coagulation therapy
Avidity Biosciences closes USD690m public offering of common stock
Akeso's ligufalimab (CD47 mAb) granted FDA Orphan Drug Designation for AML
Forte Biosciences highlights positive FB102 data in celiac disease at Tampere Symposium
SureSpace Launches in Dubai to Tackle Doomscrolling and Redefine Social Networking
Kodiak reports positive APEX data for KSI-101 in macular edema secondary to inflammation
Biophytis secures Brazilian funding and partnerships for obesity Phase 2 trial