Clinical Completion After 48-Week Observation Period
BioSolution, a specialized company in advanced biopharmaceuticals, announced on the 15th that it has completed dosing patients in the US Phase 2 clinical trial of the autologous costal cartilage cell therapy 'Cartilife.'
The US FDA Phase 2 trial for Cartilife began after receiving clinical trial plan approval in November 2019 and was conducted at four clinical trial sites in California, Texas, and other locations, targeting 20 patients with knee cartilage defects. The dosing of the last patient was completed on the 12th (local time) in the US, and the trial will be completed after a 48-week observation period.
Cartilife was selected in April 2020 for the national project ‘Ministry of Health and Welfare Advanced Medical Technology Development’ and has received research funding. In August 2023, it was designated as an RMAT (Regenerative Medicine Advanced Therapy) by the FDA, raising expectations for expedited review of future clinical results.
Cartilife is an osteoarthritis treatment based on bead-shaped autologous chondrocytes derived from costal cartilage. It received domestic marketing approval from the Ministry of Food and Drug Safety in April 2019 on the condition of conducting a Phase 3 domestic study. Since September 2019, the company has been conducting the domestic Phase 3 clinical trial. As early as the first quarter of this year, it plans to announce the interim evaluation results (48-week observation) of the domestic Phase 3 trial and the '5-year long-term follow-up results' of patients from the domestic Phase 2 trial.
A BioSolution official stated, "With the dosing of the last patient in the FDA Phase 2 trial, preparations for overseas expansion have been fully completed. The US government is actively supporting the osteoarthritis treatment field, making the market outlook positive. Since Cartilife’s excellent cartilage regeneration effect and improvements in knee function and symptoms have been proven through domestic clinical results, the FDA Phase 2 trial is expected to proceed smoothly."
The company also announced plans to conduct the FDA Phase 3 clinical trial through licensing out or collaboration with local big pharma in the future.
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