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Business
Stem Cell Therapy
Organoid
CDMO Business
IR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
FURRESTEM-OA Kit. Clinical Phase 1 Status Article
10
2024.01
The Phase 1 clinical trial of FURESTEM-OA Kit., which targets the DMOAD(disease-modifying osteoarthritis drug) of osteoarthritis without surgery, is on track.
The Phase 1 clinical trial of FURESTEM-OA Kit., which targets the DMOAD(disease-modifying osteoarthritis drug) of osteoarthritis without surgery, is on track.
The low-dose group, which has entered the fifth month of treatment, will undergo an MRI-based imaging evaluation in February to confirm cartilage regeneration and subchondral bone structure improvement. Patients who have completed treatment are being monitored regularly, and to date, there have been no adverse events related to the drug. Significant improvements are also being seen in pain or overall assessment of joint function using pain scales(VAS), osteoarthritis scales(WOMAC), and knee function and activity scales(IKDC).
The mid-dose group, which completed dosing in November, also reported no significant safety-related adverse events at the one-month dose-limiting toxicity(DLT) study in January, and significant improvements in post-dose pain and joint function assessments are being observed in a much shorter period of time than in the low-dose group.
Patients in the FURESTEM-OA Kit trial are reporting significant pain reduction and functional improvements that have led to increased ease of daily living, and the mid-dose group in particular is showing greater improvement in a number of assessments and real-world activities, which is encouraging.
Kangstem Biotech plans to start dosing patients in the last clinical group, the high-dose group, this month and complete the safety evaluation and imaging evaluation of the low-dose group in February. After that, the mid-dose and high-dose groups will be conducted and completed sequentially according to the clinical trial procedure, and the Phase I clinical trial will be completed in August and the overall results will be disclosed in the second half of the year.
Meanwhile, FURESTEM-OA Kit a new drug aimed at the DMOAD of osteoarthritis with a single intra-articular injection without surgery, is currently undergoing a Phase 1 clinical trial to evaluate the safety and tolerability of low, medium, and high doses of stem cell doses and to identify the optimal recommended dose and exploratory efficacy. Dosing is designed at 2-month intervals per group, and clinical results will be presented after 6 months of observation for each cohort(group).