12 July 2018 - - Rockville, Maryland-based advanced cell therapies company Kolon TissueGene, Inc. (KOSDAQ: 950160) has received notice that the clinical hold issued by the FDA has been lifted and that the company now has FDA approval to move forward with its clinical trials involving patients diagnosed with knee osteoarthritis (OA), the company said.
The phase III trials for Invossa will enroll close to 1,020 patients at over 50 clinical sites across the US.
In addition to demonstrating significant pain and functional improvements, the company has designed the trials for Invossa to achieve a disease modifying osteoarthritis drug designation from the FDA.
Current OA patients suffer through many years of debilitating pain and reduced quality of life.
A single injection of Invossa could lead to more than two years of productive and pain free mobility, without the immediate need for surgery, and fill in this significant treatment gap.
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 US and abroad have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure.
Kolon TissueGene's mission is to provide safe and effective therapies to patients by reducing pain and improving function associated with various orthopedic diseases and degenerative disorders.
The company has developed a first-in-class cell and gene therapy targeting osteoarthritis of the knee.