Kolon confirms existence of questionable GP-293 cells in cartilage regenerating drug, Invossa. Regulatory approval up in the air

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The punches keep coming for Kolon Life Science. Not only has their breakthrough cartilage regrowth drug, Invossa, been suspended from sale in their home market of South Korea, but they have also confirmed the existence of GP-293 cells in their most recent batch of the drug.

GP-293 cells are derivatives of HEK-293 cells. HEK-293 cells are well known to differentiate into cancer cells, and replicate unchecked. Lack of disclosure of GP-293 cells’ presence in the therapy have sounded multiple alarm bells in bio-science research and regulatory circles in Korea, due to their relation to HEK-293 cells.

Health authorities in China and other countries that recently made import deals with Kolon Life Sciences are weighing their options as to whether they will pull approval for the therapy due to the lack of disclosure of these cells during clinical trials.

The Korean Ministry of Food and Drug Safety is waiting until the final investigation is finished on April 15th to make a decision on whether the approval of the drug is invalidated or kept.

This is unfortunate to hear, because Invossa is the first commercialized therapy to produce visible and viable growth of cartilage in knees and other joints. Therapies similar to this could end the practice of replacing knees, hips, and other joints.

The only good news is that if Invossa loses approval, there are several other approaches to regrowing cartilage that are between phase 2 and phase 3 clinical trials. We here at regenerative times will keep you updated on the situation as it develops.

A big thanks goes to Korea Biomed for the english language report:
http://www.koreabiomed.com/news/articleView.html?idxno=5520