Kolon TissueGene, Inc., a leader in advanced cell and gene therapies, announced that it has resumed patient dosing in its U.S. Phase III study of TG-C for the treatment of knee osteoarthritis (OA).
The two pivotal Phase III trials for U.S. approval of TG-C will enroll close to 1,020 patients at over 80 clinical sites across the U.S. During the trials, the Company will assess pain and function endpoints, as well as MRI, X-Ray, and biochemical biomarkers. In addition to significant pain and function improvements, the Company has designed the trials for TG-C to achieve a Disease Modifying Osteoarthritis Drug or “DMOAD” designation. The trial investigators will include orthopedic surgeons, rheumatologists, and pain specialists.
“Today’s dosing of a patient in the US Phase III study demonstrates the continued commitment of Kolon TissueGene to develop a product that will make a real difference for knee OA patients,” stated Dr. Moon Jong Noh, Co-CEO of Kolon TissueGene, Inc. “A therapy that targets not only short-term pain, but improves a patient’s pain and function for a significant duration will be a game changer for OA patients worldwide,” said Dr. Sung Han, Co-CEO of Kolon TissueGene, Inc.
Kolon TissueGene, Inc. is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. Kolon TissueGene’s lead product, TG-C, is an allogeneic cell and gene therapy. The Company has plans for two pivotal Phase III clinical trials in knee OA in the U.S., the first under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA).
TG-C [TissueGene-C] is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. In clinical trials held in the U.S. and abroad to date, TG-C has demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic drug could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions.