Kolon Inbo Carcinogenic Risk Controversy
- INCHEON, South Korea – Clinical trials of Kolon TissueGene's TG-C, previously known as Invossa, have demonstrated no evidence of tumor formation, according to long-term tracking data.The findings aim...
- The company presented data from a 15-year follow-up study at the Osteoarthritis Research Society International (OARSI) World Congress, held in Songdo, Incheon, from Oct.
- Moreover, the study found that the incidence of cancer in patients treated with TG-C, even in organs unrelated to the treatment area, was lower than the cancer incidence...
Kolon TissueGene‘s TG-C Shows No Cancer link in Long-Term US Study
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INCHEON, South Korea – Clinical trials of Kolon TissueGene’s TG-C, previously known as Invossa, have demonstrated no evidence of tumor formation, according to long-term tracking data.The findings aim to quell concerns about potential carcinogenic risks that previously led to the revocation of the treatment’s market authorization in South Korea.
The company presented data from a 15-year follow-up study at the Osteoarthritis Research Society International (OARSI) World Congress, held in Songdo, Incheon, from Oct. 24-27. The analysis included 33 patients from a Phase 2 trial in the United States and 110 patients from other clinical trials. Results indicated no instances of cancer directly attributable to TG-C.
Moreover, the study found that the incidence of cancer in patients treated with TG-C, even in organs unrelated to the treatment area, was lower than the cancer incidence rate reported by the U.S.National Cancer Institute (NCI) for the general American population.
Reduced Need for Joint Replacement
Data also suggested that patients receiving TG-C for osteoarthritis experienced a lower rate of artificial joint replacement compared to a “virtual control group” derived from National institutes of Health (NIH) data on osteoarthritis patients. The study indicated that 7% of the TG-C group required artificial joint surgery after the onset of osteoarthritis, while the control group experienced a rate more than twice as high.
The treatment also appeared to delay the need for surgery. Among patients who underwent artificial joint replacement, the Kolon TissueGene group had surgery an average of 5.7 years after the onset of osteoarthritis, compared to 5.1 years in the control group.
According to a Kolon TissueGene official, the company believes TG-C has the potential to be recognized as a disease-modifying osteoarthritis drug (DMOAD), offering a fundamental approach to treating osteoarthritis and promoting cartilage regeneration. Currently, there is no cure for osteoarthritis approved by the U.S. food and drug Governance (FDA).
About TG-C
TG-C is a cell-mediated gene therapy designed for knee osteoarthritis. It involves injecting a mixture of cartilage cells and the anti-inflammatory gene TGF-beta 1 into the joint space. The company claims that a single, approximately 10-second injection can provide pain relief and improved functionality for up to two years.
Past Regulatory Issues and Future plans
TG-C initially received regulatory approval in South Korea in 2017 under the name Invossa.However, the approval was rescinded in 2019 after it was discovered that the clinical drug contained cells different from those authorized. The potential risk of carcinogenicity from the mixed cells was a primary concern.
Following a year-long review, the FDA allowed Kolon TissueGene to resume Phase III clinical trials of TG-C in 2020. The FDA accepted Kolon TissueGene’s argument that manufacturing process controls,including radiation to prevent cell division,effectively mitigate the risk of cancer.
Kolon TissueGene intends to submit a Biologics Licence Request (BLA) to the FDA in the second half of next year, pending the completion of ongoing U.S. clinical trials.
Kolon TissueGene’s TG-C: Key Facts About the Osteoarthritis Treatment
This article explores Kolon TissueGene’s TG-C, a cell-mediated gene therapy for knee osteoarthritis, examining its safety, efficacy, and regulatory journey based on the provided source material.
What is TG-C?
TG-C, formerly known as Invossa, is a gene therapy designed to treat knee osteoarthritis. The treatment involves a single injection into the knee joint, containing a mixture of cartilage cells and the anti-inflammatory gene TGF-beta 1.
Is TG-C Safe?
According to the provided information, long-term clinical trials of TG-C in the United States have shown no evidence of tumor formation or cancer directly linked to the treatment. The study found the cancer incidence in patients receiving TG-C to be even lower than the general American population.
What are the Benefits of TG-C?
Pain Relief and Improved Functionality: Kolon TissueGene claims that a single TG-C injection can provide pain relief and improved function for up to two years.
reduced Need for Joint Replacement: The study indicated that patients receiving TG-C had a lower rate of artificial joint replacement compared to a control group.
* Delayed Need for Surgery: TG-C appeared to delay the need for artificial joint replacement surgery in patients.
How Does TG-C compare to Other Osteoarthritis Treatments?
The article notes that there is currently no cure for osteoarthritis approved by the FDA. TG-C has the potential to be recognized as a Disease-Modifying Osteoarthritis Drug (DMOAD), aiming for a essential approach to treating the condition and promoting cartilage regeneration.
Have There Been any Regulatory Issues with TG-C?
Yes. TG-C (Invossa) initially received approval in South Korea in 2017. However, the approval was rescinded in 2019 due to the discovery of different cell types in the drug than originally authorized. The FDA allowed Kolon TissueGene to resume Phase III clinical trials in 2020 after the company demonstrated manufacturing process controls to mitigate cancer risks.
Summary of Key Findings
| Feature | Finding |
| ——————– | ———————————————————————————————————– |
| Cancer Risk | no evidence of tumor formation or increased cancer incidence in treated patients. |
| Joint Replacement | Lower rate of artificial joint replacement compared to a virtual control group.|
| Surgery Delay | Surgery was delayed by an average of 0.6 years in the TG-C group compared to the control group. |
| Regulatory History | Initially approved in South Korea; approval revoked; US FDA allowed trials to resume after addressing concerns. |
What are Kolon TissueGene’s Future Plans for TG-C?
Kolon TissueGene intends to submit a Biologics License Request (BLA) to the FDA in the second half of next year, contingent on the completion of ongoing U.S. clinical trials.