- Source : Press Release
- Date : 2019-09-09
- Event type : Phase 3
- Companies : Kang Stem Biotech Co., Ltd.
Kangstem Biotech to Announce 'PureStem AD' Three-Phase Result This Year… "Apply for Early Next Year"
[Medical Today, Lee Kyung-ho] Phase III clinical results of the world's first atopy stem cell therapy 'FURESTEM-AD' will be announced this year.
Kangstem Biotech said it will release the results of Phase 3 clinical trials of PureStem AD in December this year. In the 1 / 2a phase announced in November last year, the three-year long-term follow-up result confirmed significant efficacy and safety. We are also excited about the results of the trial.
Kangstem Biotech has informed participants of Phase 3 clinical trials at PureStem AD, which ended in June, of drug-placebo status since late August. As the analysis of the collected data was finalized, it appeared that the double blind was released.
In November of last year, Kangstem Biotech showed three years of long-term follow-up of 'PureStem AD' for phase 1 and did not show any safety-related side effects. The effectiveness of treatment continued until 3 years after administration. Confirmed the results.
Kangstem Biotech received the Phase III clinical trial plan from the Korea Food and Drug Administration in December 2017 for 'PureStem AD stock', and from April 2013 at 11 leading hospitals in Korea including Seoul St. Mary's Hospital, Seoul National University Hospital and Seoul Asan Hospital A total of 197 patients with moderate to severe chronic atopic dermatitis were diagnosed.
Stem cell therapy was successfully completed in Phase III clinical trials within 1 year and 7 months until the end of 6 months after the patient's administration due to the high interest of clinicians and patients, despite the exceptionally large scale. Has achieved results. Kangstem Biotech plans to open the final clinical results at the end of this year and apply for the approval of KFDA items in the first quarter of next year. In addition, the company is trying to commercialize domestically and enter phase II clinical trials in Europe by next year.