FDA Submits Phase I/II Study Protocol for Delta-Fly Pharma's DFP-10917 in Pretreated AML Patients

Delta-Fly Pharma, a biopharmaceutical company, has recently announced significant progress in its research and development efforts. The company has submitted a protocol to the FDA for a Phase I/II study, which combines DFP-10917 with Venetoclax (VTX) for patients with acute myeloid leukemia (AML) who have previously been treated with VTX. This submission was completed on March 8th, 2024, and the study is expected to commence at Wake Forest and other hospitals following FDA approval.

Additionally, Delta-Fly Pharma is conducting an interim analysis of a Phase III study involving DFP-10917 for patients with recurrent or refractory AML. This analysis is taking place in multiple centers across the United States and is aimed at evaluating the impact of long-term survivor patients on overall survival (OS) analysis.

The company has also secured patents for a combination therapy using DFP-14927 with VTX for AML in Japan, the United States, and Taiwan. This innovative approach is designed to address the needs of cancer patients who have limited treatment options.

Delta-Fly Pharma's commitment to developing new therapies for cancer patients is evident through their ongoing studies and successful patent acquisitions. The company's focus on innovative treatments could potentially lead to significant advancements in the field of oncology, offering hope to those battling this devastating disease.