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Stem Cell Therapy
Organoid
CDMO Business
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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. Phase 1 Clinical Status, News During Analysis of Imaging Evaluation in Low-Dose Groups
08
2024.03
MRI images of the low-dose arm of Kangstem Biotech's Phase 1 osteoarthritis treatment FURESTEM-OA Kit Inj. show that swelling and cysts in the articular cartilage and subchondral bone expected to hrunk or partially disappeared in some patients.
MRI images of the low-dose arm of Kangstem Biotech's Phase 1 osteoarthritis treatment FURESTEM-OA Kit Inj. show that swelling and cysts in the articular cartilage and subchondral bone expected to hrunk or partially disappeared in some patients.
FURESTEM-OA Kit is intended to treat osteoarthritis without surgery through an intra-knee injection, and all patients in the Phase 1 clinical trial were dosed last month. The company is currently conducting MRI-based imaging analysis of patients in the lowest dose arm of the Phase 1 trial, which contains the lowest amount of stem cells.
In the low-dose arm of the trial, which has been ongoing since August of last year, all patients have demonstrated greater than expected pain improvement and efficacy, and in some highly responsive patients, MRI imaging has visible swelling and cysts in the articular cartilage and subchondral bone appear partial disappearance of the capsule, further increasing the likelihood of success in the treatment of osteoarthritis.
Currently, the preliminary analysis of MRI imaging evaluation is underway in addition to the existing pain assessment measures such as VAS, KOOS, and IKDC, and the analysis of the results in relation to the level of change and validity of seven biomarkers related to chondrogenesis is underway. For more accurate results of the MRI image analysis, we plan to conduct an in-depth analysis based on the preliminary analysis scores and add medical opinions and specific interpretations from osteoarthritis specialists to increase reliability.
In particular, the mid-dose group with higher stem cell content is showing a dramatic effect at a much faster rate than the low-dose group from the beginning of treatment, with pain reduction and improvement of more than 60-70% compared to the pre-treatment period through a single injection. This is an excellent improvement rate that has not been seen in any drug developed to date and is expected to lead to structural improvement(cartilage regeneration) of the knee joint.
Given the encouraging results seen in the MRI analysis of the low-dose arm, we expect to see even greater results at the mid-dose and beyond. In addition, based on the results of the primary MRI image analysis of the low-dose group, in-depth analysis data, and biomarker analysis, we will share the results with domestic and foreign big pharmaceutical companies and accelerate early technology export to increase the business value of new drug development.