TissueGene has completed enrolling patients in a US-based Phase II trial of its TG-C therapy, designed to treat patients with Grade 3 chronic degenerative joint disease (DJD) of the knee.
Comprising human allogeneic chondrocytes, the TG-C therapy produces the therapeutic protein TGF-beta1 to regenerate cartilage of the knee.
The double-blind, placebo-controlled study, which is designed to evaluate the safety and efficacy of TG-C, has randomized patients to receive intra-articular injection of either TG-C or placebo to the damaged joint area.
The company said patients will be followed for two years with the primary efficacy endpoint analysis being conducted once all patients have reached their one year follow-up.
In addition, TissueGene’s licensing partner, Kolon Life Science, has completed patient enrollment for a Phase IIb study of TG -C therapy in Korea.
TissueGene chief medical officer Kwan Hee Lee said, "We are very pleased with the clinical progress of TG-C in both the US and Korea and look forward to reporting our Phase II data in 2013."