Kolon TissueGene Resumes Patient Dosing in US Phase 3 Clinical Trial for Osteoarthritis Treatment

[Asia Economy Reporter Seo Sojeong] Kolon TissueGene (CEO Han Seongsu and Noh Moonjong) has resumed dosing for patients enrolled in the Phase 3 clinical trial of 'TG-C,' a cell and gene therapy for knee osteoarthritis in the United States.

Kolon TissueGene announced on the 28th that dosing for clinical trial patients resumed on the 27th (local time) at Source Healthcare Hospital in Santa Monica, California. The teams participating in the Phase 3 trial consist of medical staff from about 80 university hospitals and specialized clinics across the U.S., including Mount Sinai Hospital, New York University Hospital, and Rothman Orthopaedics, which have played pivotal roles in osteoarthritis treatment.

Going forward, Kolon TissueGene plans to complete dosing for a total of 1,020 patients (including 11 who have completed prior clinical trials) at approximately 80 clinical sites nationwide by 2023.

TG-C is a bio-drug in the form of an injection that directly administers the drug into the knee joint cavity, differing from existing knee osteoarthritis treatments such as surgery, narcotic painkillers, or physical therapy. Kolon TissueGene designed the clinical trial so that TG-C could be approved as a fundamental treatment (DMOAD: Disease-modifying Osteoarthritis Drug) capable of not only pain control and functional improvement but also structural improvement of the joint. Globally, no treatment has yet been recognized as a DMOAD.

Han Seongsu, CEO of Kolon TissueGene, said, "We will successfully complete the clinical trial and establish ourselves as a game changer in the global osteoarthritis market, not just in the U.S."

In May 2019, Kolon TissueGene received a Clinical Hold designation from the U.S. Food and Drug Administration (FDA) and submitted additional experimental data regarding the origin error of the TG-C two-component cells and their characteristics. After reviewing the additional data submitted by Kolon TissueGene, the FDA lifted the clinical hold in April of last year.