On September 10, 2024 Delta-fly pharma reported that a phase I/II clinical trial of DFP-10917 in combination with venetoclax (VEN) in patients with acute myeloid leukemia (AML) who have received prior VEN-containing therapy was approved by the U.S. Food and Drug Administration (FDA) on April 8, 2024 ( Delta-Fly Pharma Inc: Notice of Authorization to Conduct Phase I/II Study of DFP-10917 in Combination with Venetoclax | Business Wire ) (Press release, Delta-Fly Pharma, SEP 10, 2024, View Source [SID1234646492]). Today, we are pleased to announce that the first patient has been enrolled at the University of Virginia Hospital based on Investigational Review Board (IRB) approval. The University of Virginia Hospital is the clinical site that has enrolled the most patients in the Phase III study of DFP-10917 as a single agent in patients with relapsed/refractory AML.

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Pharmaceutical companies have already expressed interest in the Phase III study of DFP-10917 as a monotherapy. In addition, many companies, including pharmaceutical giants, have expressed interest in the Phase I/II combination study of DFP-10917 with VEN, due to the large potential market size for the treatment of AML.

VEN alone is not effective against AML, but it becomes effective in combination with azacitidine (DNA methylation inhibitor), which is currently recognized as a standard treatment for AML despite safety concerns. We will therefore provide significantly more combination therapy of VEN and DFP-10917 (G2/M arrest) compared to the current standard treatment for AML. Up to 39 patients will be enrolled in this study. The endpoints are complete remission rate and progression-free survival. After the completion of the Phase I/II study, Delta-Fly Pharma, Inc. will cooperate with a pharmaceutical giant to file a New Drug Application (NDA).

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