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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
FURESTEM-OA Kit Inj. News of Initiation of Phase 1 High-Dose Group Drugs
02
2024.02
In late January, Kangstem Biotech began dosing the high-dose arm of its Phase 1 clinical trial of osteoarthritis treatment “FURESTEM-OA Kit Inj.”.
In late January, Kangstem Biotech began dosing the high-dose arm of its Phase 1 clinical trial of osteoarthritis treatment “FURESTEM-OA Kit Inj.”. FURESTEM-OA Kit aims to treat osteoarthritis by regenerating cartilage tissue through a single intra-articular injection in the knee joint cavity.
Dosing of the last group in the Phase 1 trial, the high-dose arm, is expected to be completed quickly in February. As a result of regular observation of the condition of patients in the low and medium dose groups who have completed treatment, significant improvements in IKDC(knee function and activity assessment) and VAS(pain index) have been confirmed, especially in the medium dose group compared to the low dose group, and the efficacy of the high dose group is expected to be even more promising.
"We expect that this clinical trial will confirm the safety of FURESTEM-OA Kit for patients with moderate knee osteoarthritis, as well as structural improvements such as pain relief and cartilage regeneration," said Yohan Bae, head of clinical development at Kangstem Biotech. "After completing Phase I, we will quickly enter Phase II in Korea, and at the same time, we plan to apply for RMAT(Advanced Regenerative Medical Therapy) from the FDA and proceed with global clinical trials and commercialization in cooperation with pharmaceutical companies that understand the osteoarthritis market and have experience in multinational clinical trials."