Tecosience Reports Completion of Clinical Trial for 'TPX-115'
[Asia Economy Reporter Ji-hwan Park] TegoScience announced on the 4th that it has reported the completion of the Phase 1/2 clinical trial evaluating the safety and efficacy of TPX-115 in patients with partial-thickness rotator cuff tears to the Ministry of Food and Drug Safety.
TPX-115 is an allogeneic cell therapy developed for the treatment of partially torn rotator cuffs. In March 2020, TegoScience received approval from the Ministry of Food and Drug Safety for the Phase 1/2 clinical trial plan of TPX-115 and conducted clinical trials at Bundang Seoul National University Hospital and Seoul National University Hospital. This clinical trial completion report was submitted after completing the observation of all enrolled subjects and in accordance with relevant regulations to the Ministry of Food and Drug Safety.
A TegoScience official stated, "Observation was completed without any serious adverse events reported in all clinical trial subjects," and added, "We expect to obtain good results in the efficacy evaluation, which is anticipated to be completed in the third quarter of this year."
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TegoScience is preparing not only domestic clinical trials for TPX-115 but also overseas trials, and plans to apply for Phase 3 clinical trials in Korea and Phase 2 clinical trials in the United States this year.
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