Delta-Fly Pharma Inc. has announced the enrollment of the first patient in its Phase I/II clinical trial evaluating the combination of DFP-10917 and Venetoclax for patients with relapsed or refractory acute myeloid leukemia (AML) who have previously received Venetoclax-based treatment. The trial is being conducted at the University of Virginia Hospital, a site with experience in Delta-Fly Pharma's previous DFP-10917 monotherapy Phase III study.
The FDA approved the Phase I/II study on April 8, 2024. The trial aims to enroll a maximum of 39 patients to assess the combination therapy's efficacy, measured by complete remission (CR) rate and progression-free survival (PFS).
Rationale for Combination Therapy
Venetoclax, while effective in combination with Azacitidine (a DNA methylation inhibitor), has limitations and safety concerns as a standard AML therapy. Delta-Fly Pharma is developing DFP-10917, a G2/M arrest inducer, to provide a potentially safer and more effective combination with Venetoclax.
Interest from Pharmaceutical Companies
Delta-Fly Pharma has received interest from multiple pharmaceutical companies, including major players, regarding the Phase I/II combination study. This interest is driven by the significant market potential in AML treatment.
Study Endpoints and Future Plans
The primary endpoints of the Phase I/II study are the complete remission (CR) rate and progression-free survival (PFS). Upon successful completion of the trial, Delta-Fly Pharma intends to collaborate with a major pharmaceutical company to pursue a New Drug Application (NDA).
