MedPacto "Anticancer New Drug 'Bactosertib', Combination Clinical Trial Approved"
[Asia Economy Reporter Cho Hyun-ui] MedPacto announced on the 9th that it has received approval from the Ministry of Food and Drug Safety for a Phase 1b/2a clinical trial plan combining its anticancer drug candidate 'Bactosertib' (TEW-7197) and the chemotherapy drug 'Paclitaxel' in gastric cancer patients.
This approval expands the ongoing Phase 1b trial, which started in January 2018, to the Phase 2a stage.
MedPacto plans to explore the safety and efficacy of administering Bactosertib and Paclitaxel together in gastric cancer patients during the clinical trial.
The clinical trial has been approved for a total of 54 subjects, including 18 in Phase 1b and 36 in Phase 2a. Since safety data required for entry into Phase 2a have already been secured from the completed Phase 1b, the Phase 2a trial will commence immediately. The trial will be conducted at five institutions, including Severance Hospital, and is expected to be completed within next year.
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A MedPacto official stated, "Since the combination clinical trial of Bactosertib and immuno-oncology agents is progressing smoothly, we expect excellent results in the combination trial with the chemotherapy drug Paclitaxel as well."
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