TissueGene To Present Clinical Trial Data For Its Cell And Gene Therapy For Osteoarthritis At Cell Therapy World Asia 2017
Rockville, Maryland, September 15, 2017 - TissueGene, Inc. (TissueGene), an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting osteoarthritis (OA) of the knee, announced today that CEO Bumsup Lee, Ph.D., will present at Cell Therapy World Asia 2017, which takes place in Seoul, Korea from September 19-20, 2017.
Dr. Lee will present a talk on September 19 at 3:45 p.m. KST entitled, "Allogeneic cell and gene therapy, Invossa, for US phase 3 trials for DMOAD." Dr. Lee will discuss the compelling efficacy results seen in the U.S. and Korean trials conducted to date for Invossa (TG-C), the Company's first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. He will also cover plans for the upcoming U.S. Phase III clinical trial that is slated to begin in 2018.
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. Following a planned national U.S. Phase III clinical trial, TissueGene intends to demonstrate a two-year improvement of pain and function. 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 a DMOAD label. In July 2017, Kolon Life Science, Inc., TissueGene's exclusive licensee for Asia, received marketing approval from the South Korea Ministry of Food & Drug Safety (MFDS) for Invossa-K Inj.
About TissueGene, Inc.
TissueGene, Inc., is an advanced cell therapies company that has developed a first-in-class cell and gene therapy targeting OA of the knee. TissueGene's lead product, Invossa™, is an allogeneic cell and gene therapy. The Company is preparing for 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 TissueGene, Inc., please visit www.tissuegene.com.
Released September 15, 2017