On March 11, 2024 Delta-Fly Pharma reported that Following to the previous information on Jan. 30th. in 2024, we are excited to share our latest development status (Press release, Delta-Fly Pharma, MAR 11, 2024, https://www.businesswire.com/news/home/20240311048389/en/Delta-Fly-Pharma-Inc.-FDA-submission-of-the-protocol-of-the-Phase-III-study-of-DFP-10917-combined-with-Venetoclax-VTX-in-the-AML-patients-pretreated-by-VTX-involved-one-regimen [SID1234641039]).
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FDA submission of the protocol of the Phase I/II study of DFP-10917 combined with Venetoclax (VTX) in the AML patients pretreated by VTX involved one regimen have been done on March 8th, 2024.
The Phase I/II study of DFP-10917 with VTX in the above AML patients shall be started at Wake Forest and the other hospitals soon after FDA approval.
The interim analysis of the Phase III study of DFP-10917 in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US is undergoing for the reason there are patients with a long-term survival may effect on OS analysis.
The invention with the combination of DFP-14927 with VTX in AML was granted in Japan, US, and Taiwan.
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