TissueGene has leveraged its international presence to advance the scientific and regulatory aspects of its lead product candidate TG-C. TG-C is an allogeneic (donor) cell therapy involving human chondrocytes (cartilage cells) expressing the therapeutic growth factor TGF-ß1 and has been developed to treat osteoarthritis through the regeneration of cartilage. To date, a Phase I study for TG-C has been successfully completed in the US and a Phase IIa study for TG-C has been successfully completed in Korea. TG-C has been found to be well-tolerated at all dose levels with no treatment-related severe adverse events. Results from the symptomatic evaluation and MRI analysis suggested a dose-dependent improvement in both arthritic symptoms and cartilage regeneration. Currently, patient enrollment for a TG-C Phase II study in the US and a TG-C Phase IIb study in Korea are in progress.
TG-C Phase II Protocol: US
The US Phase II study for TG-C is designed as a multi-center, double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of TG-C in 100 patients with Grade 3 chronic degenerative joint disease of the knee. The primary efficacy endpoints will be the IKDC Subjective Knee Evaluation and VAS, with KOOS, Lysholm and LEFS scores as well as MRI scans assessed secondarily. Initiation of patient enrollment for the US Phase II study began in 2Q 2011. For more information regarding this study, please visit www.clinicaltrials.gov and reference NCT01221441.
TG-C Phase IIb Protocol: Korea
The single-dose Phase IIb clinical trial for TG-C in Korea has been designed as a placebo-controlled, single-blind, randomized, multi-center study to determine the efficacy and safety of TG-C in 54 patients with degenerative joint disease of the knee. The primary efficacy endpoint will be the IKDC Subjective Knee Evaluation, with VAS, WOMAC and KOOS scores as well as MRI scans assessed secondarily. Initiation of patient enrollment for the Phase IIb study began in 3Q 2011. For more information regarding this study, please visit http://www.kolonls.co.kr/english.