Following our April 8, 2024, announcement, we’re excited to provide an update on our progress.
The U.S. Food and Drug Administration (FDA) approved a Phase I/II clinical trial for DFP-10917 in combination with venetoclax (VEN) for patients with acute myeloid leukemia (AML) who have previously been treated with VEN. Since receiving Investigational Review Board (IRB) approval, the first patient has been enrolled at the University of Virginia Hospital, a leading site for the Phase III trial of DFP-10917 monotherapy for relapsed/failure AML.
Interest in DFP-10917 has been high, with several pharmaceutical companies expressing enthusiasm for the Phase III monotherapy trial. Additionally, the Phase I/II combination trial of DFP-10917 and VEN has attracted interest from numerous companies, including major pharmaceutical firms, due to the significant market potential for AML treatments.
While VEN alone is ineffective against AML, it shows promise when combined with azacitidine (a DNA methylation inhibitor), which is currently the standard therapy despite safety concerns. Our combination therapy of VEN and DFP-10917 (targeting G2/M arrest) aims to provide a more effective alternative. The Phase I/II trial will enroll up to 39 patients, with primary endpoints being complete remission (CR) rate and progression-free survival (PFS). Upon successful completion, Delta-Fly Pharma, Inc. plans to seek approval for the new drug in collaboration with a major pharmaceutical partner.
