| | ROCKVILLE, Md., Dec. 28, 2021 /PRNewswire/ -- Kolon TissueGene, Inc. (KOSDAQ: 950160) (the “Company”), a leader in advanced cell and gene therapies, announced today 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 (2) 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. About 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). Information about the trials can be found at http://www.clinicaltrials.gov under identified number NCT03203330. For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com. About TG-C
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. In a concluded U.S. Phase II clinical trial in knee OA, Kolon TissueGene demonstrated a two-year improvement of pain and function. The Company seeks to continue to support these results through its planned national U.S. Phase III study and expand the indication to hip OA. Disclaimer
The information made available in this press release does not constitute the giving of investment advice or an offer to sell or the solicitation of an offer to buy any security of Kolon TissueGene, Inc. (the “Company”) in any jurisdiction. The securities of the Company have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state of the United States and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state or local securities laws of other jurisdictions.  View original content:https://www.prnewswire.com/news-releases/kolon-tissuegene-resumes-tg-c-phase-iii-studies-in-the-us-301451208.html
SOURCE TissueGene, Inc. | |
