Kolon Tea Shujin, Bone Hip Society Institute for Cell Gene Therapy
- INCHEON,South Korea – Kolon TissueGene presented findings demonstrating the safety and efficacy of it's osteoarthritis cell gene therapy,TG-C,at the Osteoarthritis Research Society International (OARSI) World Congress,held in Songdo...
- The company's presentation, centered on "TG-C, a potential disease-modifying osteoarthritis drug (DMOAD): Long-term safety and delaying knee replacement surgery through cell gene therapy," highlighted the potential of TG-C...
- The research encompassed 110 patients who participated in Phase II and Phase III clinical trials in the United states over a two-year period.
Kolon TissueGene Presents Osteoarthritis Therapy Data at OARSI
INCHEON,South Korea – Kolon TissueGene presented findings demonstrating the safety and efficacy of it’s osteoarthritis cell gene therapy,TG-C,at the Osteoarthritis Research Society International (OARSI) World Congress,held in Songdo Convensia,Incheon,from April 24-27.
The company’s presentation, centered on “TG-C, a potential disease-modifying osteoarthritis drug (DMOAD): Long-term safety and delaying knee replacement surgery through cell gene therapy,” highlighted the potential of TG-C to postpone or eliminate the need for artificial joint replacement, based on long-term follow-up data from U.S. clinical trials.
The research encompassed 110 patients who participated in Phase II and Phase III clinical trials in the United states over a two-year period. Data from the ongoing Phase III trial was used to compare TG-C recipients with a placebo group, allowing for an objective assessment of TG-C’s long-term safety profile and therapeutic benefits.
Long-Term Safety Profile
Kolon TissueGene emphasized the absence of tumor-related adverse events linked to TG-C during approximately 15 years of long-term monitoring in the United States.The company stated that the incidence of cancer among TG-C clinical trial participants was lower than the average cancer rate for comparable age groups within the general U.S. population, further supporting TG-C’s safety profile.
Efficacy in Delaying Knee Replacement
The company also presented data suggesting TG-C’s effectiveness in delaying or preventing knee replacement surgery. Kolon TissueGene compared data on knee replacement surgery rates in U.S. osteoarthritis patients with data from patients participating in the TG-C clinical trial. Using data from a National Institutes of Health (NIH) osteoarthritis project that has collected data for the past 11 years, researchers analyzed a subset of 595 patients. The analysis showed that 15.5% of these patients underwent knee replacement surgery within 5.1 years of osteoarthritis onset.
in contrast,only 7.0% of patients who participated in the TG-C clinical trials required knee replacement surgery. furthermore,the average time from osteoarthritis onset to surgery increased to 5.7 years for TG-C recipients. These findings suggest that TG-C may delay the need for, or potentially replace, artificial joint replacement in patients with knee osteoarthritis.
We are pleased to introduce TG-C’s meaningful data at OARSI, which is being held for the first time in Korea.
Representative, Kolon TissueGene
Kolon TissueGene Presents osteoarthritis Therapy Data at OARSI
This article summarizes teh key findings presented by Kolon TissueGene at the Osteoarthritis Research Society International (OARSI) World Congress, held in Incheon, South Korea. the presentation focused on the company’s cell gene therapy, TG-C, and its potential to treat knee osteoarthritis.
What is TG-C?
TG-C is a cell gene therapy developed by Kolon TissueGene. It is being investigated as a potential disease-modifying osteoarthritis drug (DMOAD).The company presented data showcasing TG-C’s long-term safety profile and its effectiveness in delaying knee replacement surgery in patients with osteoarthritis.
Key Findings from the OARSI Presentation
Kolon TissueGene presented data at the OARSI World Congress highlighting the safety and efficacy of TG-C based on long-term follow-up data from U.S. clinical trials. Here are the key takeaways:
Safety: The company emphasized that during approximately 15 years of long-term monitoring in the United States, no tumor-related adverse events were linked to TG-C.
Cancer Incidence: Data indicated that the incidence of cancer among TG-C clinical trial participants was lower than the average cancer rate in the general U.S. population of comparable age groups, further supporting TG-C’s safety.
Efficacy: Findings suggest that TG-C is effective in delaying or perhaps preventing knee replacement surgery in osteoarthritis patients.
How Does TG-C delay Knee Replacement?
The data presented suggested that TG-C may delay the need for knee replacement surgery. This conclusion is drawn from the comparison of data from the TG-C clinical trials with data from a separate National Institutes of Health (NIH) osteoarthritis project.
Key Data Points:
Osteoarthritis Onset to Surgery (Control Group): 15.5% of patients in the NIH osteoarthritis project underwent knee replacement within 5.1 years of the onset of osteoarthritis.
Osteoarthritis Onset to Surgery (TG-C Patients): Only 7.0% of patients in the TG-C clinical trials required knee replacement surgery.
time to Surgery: The average time from osteoarthritis onset to knee replacement surgery increased to 5.7 years for patients who received TG-C.
This suggests that TG-C may help to slow the progression of osteoarthritis and therefore reduce the need for joint replacement.
Comparison of Knee Replacement Rates
Here’s a simplified comparison of the knee replacement surgery rates based on the presented data:
| Group | Knee Replacement Surgery Rate | Average Time from Onset to Surgery |
|---|---|---|
| NIH Osteoarthritis Project (Control) | 15.5% within 5.1 years | 5.1 years |
| TG-C Clinical Trial Recipients | 7.0% | 5.7 years |
Where was the OARSI World Congress Held?
The OARSI World Congress where Kolon TissueGene presented its findings was held in Songdo Convensia, Incheon, South Korea, from April 24-27.
What Does This Mean for Patients?
These findings are encouraging for patients with knee osteoarthritis. TG-C shows promise in potentially delaying or preventing the need for knee replacement surgery. However, it is crucial to consult with a healthcare professional to understand whether TG-C is a suitable treatment option.
Future Outlook
Kolon TissueGene’s presentation at OARSI highlights the potential of TG-C. Kolon TissueGene’s Representative stated they are pleased to introduce this notable data at OARSI, held for the first time in korea. Further research and long-term studies are needed to fully understand the long-term benefits and risks associated with TG-C.