[Asia Economy Reporter Jang Hyowon] Kolon TissueGene announced on the 3rd that the review process by the U.S. Food and Drug Administration (FDA) for the protocol of the Phase 2 clinical trial of TG-C for hip osteoarthritis has been completed.
The clinical trial protocol was submitted on October 4th and approved by the FDA on the 2nd. Accordingly, the clinical trial is planned to be conducted at approximately 25 hospitals in the United States. The purpose of the trial is to evaluate the safety and efficacy of TG-C in patients with hip osteoarthritis.
The target patient population for the trial is about 255 individuals, with a follow-up period of 12 months after administration.
The company explained, "The completion of the FDA review process for the Phase 2 clinical trial protocol of TG-C for hip osteoarthritis means that the FDA has completed its review of the clinical trial protocol submitted through an IND Amendment to an existing effective IND, rather than a new IND application procedure as recommended by the FDA. This is understood as FDA approval to proceed with the clinical trial as planned."
They added, "The company is currently focusing on the Phase 3 clinical trial for knee osteoarthritis (Knee OA), and the initiation of the Phase 2 clinical trial for hip osteoarthritis (Hip OA) will be decided later considering various conditions."
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