Delta-Fly Pharma Begins Phase I/II Study of DFP-10917 with Venetoclax in AML Patients

TOKUSHIMA, Japan--Delta-Fly Pharma Inc. is thrilled to announce significant progress in their development efforts following the information released on April 8th, 2024. Notably, the U.S. Food and Drug Administration (FDA) has authorized a Phase I/II clinical trial involving the combination of DFP-10917 with Venetoclax (VEN) for patients with acute myeloid leukemia (AML) who have previously undergone one treatment regimen involving VEN. This approval was granted on April 8, marking a vital milestone for the company.

Following the FDA's green light, the first patient has been successfully enrolled in this clinical trial at the University of Virginia Hospital. This institution played a significant role in the Phase III study of DFP-10917 monotherapy for patients with failed or relapsed AML, enrolling the highest number of participants for that trial.

The Phase III study of DFP-10917 monotherapy has already sparked interest among several pharmaceutical companies. This promising outlook extends to the Phase I/II combination study of DFP-10917 and VEN, which has attracted attention from many, including major pharmaceutical enterprises, due to the substantial market potential in AML treatment.

Venetoclax, as a standalone treatment, is not effective against AML. However, it shows efficacy when used with Azacitidine, a DNA methylation inhibitor, which is the current standard therapy for AML despite various safety concerns. The combination of VEN and DFP-10917 offers a potentially more favorable alternative. DFP-10917 works by inducing G2/M cell cycle arrest, which could complement the mechanism of VEN, providing a more effective and safer treatment option compared to the existing standard therapy.

The clinical trial aims to enroll up to 39 patients, with primary endpoints being the complete remission (CR) rate and progression-free survival (PFS). The successful conclusion of this Phase I/II trial could pave the way for Delta-Fly Pharma, Inc. to collaborate with a major pharmaceutical company to pursue a New Drug Application (NDA).

Delta-Fly Pharma Inc. is committed to innovative approaches in treating severe cancer patients and looks forward to sharing further developments.

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