Kangstem Biotech Reapplies for Clinical Phase 1/2a of 'Purestem-OA Kit Injection'

[Asia Economy Reporter Lee Chun-hee] Gangstem Biotech announced on the 15th that it has reapplied for the Phase 1/2a clinical trial plan of the knee osteoarthritis treatment 'Purestem-OA Kit Injection,' which it had previously voluntarily withdrawn.

Gangstem Biotech had previously applied to the Ministry of Food and Drug Safety (MFDS) last August 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. However, on the 20th of last month, with the enforcement of a new law, both the health authorities and the company determined that additional data related to the investigational drug was required, leading to a voluntary withdrawal.

The MFDS requested Gangstem Biotech to provide additional xenogenic virus contamination test results to confirm that the investigational drug was 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.

Accordingly, Gangstem Biotech confirmed the absence of xenogenic viruses through virus testing and outsourced additional culture method tests to the U.S.-based contract testing organization Charles River. However, considering the administrative processing period required, it was deemed difficult to complete the additional tests and analyses within the timeframe, leading to the decision for voluntary withdrawal.

A Gangstem Biotech official stated, "After receiving the request for additional data, we promptly proceeded with supplementing the data and preparing for reapplication by outsourcing the relevant tests to specialized institutions," adding, "We will do our best to obtain approval within this year and commence clinical trials."

This content was produced with the assistance of AI translation services.