
Kolon TissueGene (Kosdaq: 950160) has reported that the first of two pivotal US Phase III trials of TissueGene-C (TG-C), its experimental cell and gene therapy for knee osteoarthritis, missed its co-primary efficacy endpoints.
The ACTiVION-II study evaluated a single intra-articular injection of TG-C against placebo in 531 patients with Kellgren-Lawrence Grade 2 or 3 osteoarthritis of the knee. At 12 months, TG-C failed to show statistically significant improvements on either the Visual Analog Scale (VAS) pain score or the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score.
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