Announced details
Second-line treatment for relapsed or refractory acute myeloid leukemia (AML)
Overall response rate of 50% in Phase 1 and 53% in the Phase 2 expansion cohort; 4 patients proceeded to stem cell transplantation. No dose-limiting toxicities in Phase 1
6 patients enrolled in the Phase 1 cohort and 17 patients enrolled in the Phase 2 expansion cohort
The counterparty with which the Company developing DFP-10917 will conduct an end-of-Phase 2 consultation. Capital and personnel relationships: Not disclosed.
A U.S. regulatory authority. Other details: Not disclosed.
4 U.S. sites (University of Virginia Hospital, University of California Irvine Hospital, University of Vermont Hospital, and Wake Forest University Hospital)
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Evaluation results from the Data Monitoring Committee (DMC)
| Item | Details |
|---|---|
| Names of Products / Services Covered | DFP-10917, venetoclax (VEN) |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | A U.S. regulatory authority. Other details: Not disclosed. |
| Relationship with the Company | The counterparty with which the Company developing DFP-10917 will conduct an end-of-Phase 2 consultation. Capital and personnel relationships: Not disclosed. |
| Applicable area | Second-line treatment for relapsed or refractory acute myeloid leukemia (AML) |
| Location | 4 U.S. sites (University of Virginia Hospital, University of California Irvine Hospital, University of Vermont Hospital, and Wake Forest University Hospital) |
| Location scale | 4 U.S. sites. 6 patients enrolled in Phase 1 and 17 patients in the Phase 2 expansion cohort |
| Quantitative Effects | Overall response rate of 50% in Phase 1 and 53% in the Phase 2 expansion cohort; 4 patients proceeded to stem cell transplantation. No dose-limiting toxicities in Phase 1 |
| Usage history | 6 patients enrolled in the Phase 1 cohort and 17 patients enrolled in the Phase 2 expansion cohort |
| Source | Evaluation results from the Data Monitoring Committee (DMC) |
Items this document does not state (8)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.No dose-limiting toxicities were observed in the 6 patients in the Phase 1 cohort, and the DMC determined that the amended dosing regimen was safe and well tolerated. The DMC also determined that the response rate among patients with no available options, such as targeted therapies, was sufficient to recommend proceeding with future trials.