Kangstem Biotech Voluntarily Withdraws Clinical Trial Plan for Osteoarthritis Treatment Agent
Last Month's Rheumatoid Arthritis Treatment Clinical Trial
Faced Difficulties Following Failure to Achieve Statistical Significance
[Asia Economy Reporter Lee Chun-hee] Kangstem Biotech announced on the 20th that it has voluntarily withdrawn the phase 1/2a clinical trial plan for the knee osteoarthritis treatment 'Purestem-OA Kit Injection.' This follows the failure to achieve statistical significance in the phase 1/2a clinical trial of the rheumatoid arthritis treatment 'Purestem-RA Injection' last month, indicating consecutive difficulties in clinical trials.
Earlier, in August last year, Kangstem Biotech had applied to the Ministry of Food and Drug Safety for a phase 1/2a clinical trial plan to evaluate the safety and efficacy of administering Purestem-OA Kit Injection to patients with knee osteoarthritis.
The company explained that this voluntary withdrawal was due to the implementation of new legislation, leading both health authorities and the company to determine that additional data related to clinical trial drugs was necessary.
The Ministry of Food and Drug Safety additionally requested Kangstem Biotech to submit results of exogenous virus contamination tests to confirm that the clinical trial drugs were not contaminated by external viruses. This is because, with the enforcement of the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (the Advanced Regenerative Medicine Act)," it must be scientifically proven that drugs used in clinical trials, even if manufactured using cell banks, have consistent quality and safety without risk factors.
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Accordingly, Kangstem Biotech confirmed the absence of exogenous viruses through virus testing and commissioned additional culture method tests to a contract testing institution in the United States. However, considering the administrative processing period required, the company judged it difficult to complete the additional tests and analyses in time and thus voluntarily withdrew the clinical trial application. The company plans to complete the additional tests, supplement the results, and reapply to the Ministry of Food and Drug Safety for the clinical trial within the third quarter.
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