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TOKUSHIMA, Japan

Following to the previous information on April 8th. 2024, we are excited to share our latest development status.

A Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) who had one prior treatment with VEN involved regimen was approved by the US Food and Drug Administration (FDA) on April 8 this year (Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax | Business Wire). Subsequently, we are pleased to announce that the first patient was enrolled at the University of Virginia Hospital based on the approval of the Investigational Review Board (IRB). The University of Virginia Hospital is the clinical site that enrolled the most patients to the Phase III study of DFP-10917 monotherapy in patients with failed/relapsed AML.

Some pharmaceutical companies have already expressed interest in the Phase III study of DFP-10917 monotherapy. Additionally, many companies including mega pharmaceutical companies, have showed interest in the Phase I/II combo-study of DFP-10917 and VEN, because of the large potential market size in the treatment of AML.

VEN itself is not effective against AML but effective when combined with Azacitidine (DNA methylation inhibitor), which is known a standard AML therapy at present despite safety concerns were reported. Accordingly, we are going to supply much more welcome combo-therapy of VEN and DFP-10917 (G2/M arrest) comparing to current standard AML therapy. 39 patients at maximum will be enrolled to this study. The endpoints of this study are CR (complete remission) rate and PFS (progression-free survival). After successful completion of this Phase I/II study, Delta-Fly Pharma, Inc. will cooperate with a mega pharmaceutical company objective NDA (New Drug Application).

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View source version on businesswire.com: https://www.businesswire.com/news/home/20240910878901/en/