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, Invossa, is an allogeneic cell and gene therapy. The Company is conducting Phase III clinical trials in the U.S. under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA). Information about the trials can be found at the National Institutes of Health registry, www.clinicaltrials.gov. For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com.
Invossa is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. Clinical trials held in the U.S. and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. The allogeneic (off-the-shelf) drug could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. In a concluded U.S. Phase II clinical trial, Kolon TissueGene demonstrated a two-year improvement of pain and function. The company seeks to continue to support these results through its recently initiated national U.S. Phase III clinical trial. In addition, the company has designed the trial to seek a disease-modifying osteoarthritis drug (DMOAD) designation for Invossa from the U.S. Food and Drug Administration (FDA)—potentially making Invossa the first therapy to receive such a DMOAD label. In July 2017, Kolon Life Science, Inc., Kolon TissueGene's exclusive licensee for Asia, received marketing approval from the South Korea Ministry of Food & Drug Safety (MFDS) for Invossa-K Inj.
MSCRF helped by providing funding for the Maryland clinical sites of TissueGene’s pivotal US Phase III clinical trials for Invossa, a cell and gene therapy for knee osteoarthritis.