TG-C did not outperform placebo for knee pain or function in a Phase III trial

TG-C did not outperform placebo for knee pain or function in a Phase III trial

On July 20, Kolon TissueGene reported preliminary results from ACTiVION-II. Among 531 patients, a single injection of TG-C did not improve knee pain or function more than a saline placebo after one year. The company also reported that the therapy did not meet any of its prespecified secondary endpoints.

TG-C combines donor cartilage cells with genetically modified cells that produce the protein TGF-β1. The developers tested whether a single injection into the joint could relieve symptoms of knee osteoarthritis, a disease that causes pain and stiffness during everyday movement.

In ACTiVION-II, physicians randomly assigned patients with knee osteoarthritis to receive either TG-C or a saline placebo. After 12 months, they compared pain using the VAS visual scale and knee function using the WOMAC questionnaire, which assesses pain, stiffness, and difficulty with everyday movement. According to the Kolon TissueGene release, TG-C showed no statistically significant advantage in either pain or knee function.

The company also reported that the frequency and severity of adverse events were comparable between the two groups. This is a separate finding because safety and patient benefit must be assessed using different data. So far, the company has disclosed only the preliminary outcome, without effect sizes, p-values, or subgroup analyses.

ACTiVION-II tested a single injection of TG-C in patients with knee osteoarthritis. Its result applies specifically to this therapy and this patient population. Kolon TissueGene expects data from the second Phase III study, ACTiVION-I, in October.

#clinical_trials