The hits keep coming for Kolon Life Science. Early statements that the company was unaware that the GP-293 cells were present in the therapy appear to be falling apart.
Export deals with Mundipharma and other companies have fallen apart, and a complete stop-sale is in place for the cartilage regenerating drug under suspicion that the GP-293 cells may be harmful, and that the company lied about their presence, claiming they were derived from chondrocytes instead of kidneys. In addition, clinical trials in the United States have been halted.
Korea’s Ministry of Food and Drug Safety said it’s taking Kolon Life Science and Kolon TissueGene’s suspicious practices “very seriously” and is launching an on-site investigation into the universities which clinical trials are taking place in the United States to learn whether or not the therapy has harmed anyone.
Civic and medical groups in South Korea are also calling for criminal investigations at the company, and have also called the Korea’s Ministry of Food and Drug Safety’s practices into question. The class action lawsuit from patients injected is now moving.
Shares of the company are down 60% since the scandal began.
The company seems to not be completely upfront about what is going on, but still hopes to resume clinical trials and maintain regulatory approval for the therapy in South Korea. So far, we have not seen validated reports of harm from the GP-293 cells.
Invossa had shown cartilage regrowth of cartilage in every trial it has gone through, and has been in development for almost 2 decades. We are still wondering if the GP-293 cells are critical to the therapy’s efficacy and not as unsafe as suspected. South Korea’s FDA appears to be on the case – searching up and down for signs off harm.
It would be unfortunate if the first disease modifying drug for osteoarthritis were shelved. Without a drug like this on the market, sufferers of painful bone-on-bone arthritis will continue to be pushed towards mechanical joint replacements which have limited lifespans and come with a risk from death from infection.
We do wonder why KLS have been dishonest about the nature of their cell therapy. Obviously, lying about the origin of the cells would not be a wise choice. A lot of foreign news reports about KLS continue to be speculative.
We will keep you updated once we learn more.