Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax

TOKUSHIMA, Japan--(BUSINESS WIRE)--Following to the previous information on March 11th, 2024, we are excited to share our latest development status.

We are pleased to announce the protocol for the Phase I/II clinical trial of DFP-10917 combined with Venetoclax (VTX) in patients with acute myeloid leukemia (AML) with prior VTX involved one regimen, which was submitted to the FDA in US on March 8 has been approved by the FDA in US dated April 8, 2024. Accordingly, we can start the Phase I/II combo-study very soon.

The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML. This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML.

The interim analysis of the Phase III trial of DFP-10917 monotherapy in patients with recurrent or refractory AML is under follow-up for a number of long-term survivors that have a significant impact on the overall survival (OS) analysis.　

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