Delta-Fly Pharma Inc.: Update for Development Status of the Combination Study of DFP-10917 with Venetoclax

Following to the previous information on Oct. 28th. in 2024, we are excited to share our latest development status.

We are pleased to announce that the data review committee (DMC) has approved the tolerability of the first three patients enrolled in the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) (NCT06382168) conducted at five US clinical sites for patients with acute myeloid leukemia (AML) who have failed/relapsed after standard VEN therapy (first-line therapy). Additionally, the bone marrow cell count in peripheral blood in all three cases was 0 (zero) within 4 (four) weeks of starting treatment, and complete remission (CR or CRi) was confirmed by subsequent bone marrow biopsy.

Three more patients will be added at the current dosage regimen, and after confirmation of the tolerability, the study will move to Phase II. Complete remission has been observed in patients who have failed/relapsed after existing VEN combination therapy (first-line therapy), so this is expected to be a new, highly effective second-line therapy for patients with AML.

As previously reported, the data cleaning processes for interim analysis are currently underway for Phase III comparative clinical trial (150 cases) of DFP-10917 monotherapy targeting patients with AML receiving third-line or later therapy. Once this is completed, the results will be submitted to the Independent Data Safety Monitoring Committee (DSMB) along with electrocardiogram and pharmacokinetic study results for their advice.

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