- Bio-Path Holdings Inc BPTH has completed the safety run-in of Stage 2 of the Phase 2 study evaluating prexigebersen to treat acute myeloid leukemia (AML) in combination with frontline therapies, decitabine and venetoclax.
- The safety run-in comprised six evaluable patients.
- In the preliminary safety data review, five patients responded to treatment, including four achieving complete response (CR) and one complete response with incomplete hematologic recovery (CRi).
- CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52% and 0-39% for relapsed/refractory secondary AML patients.
- Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients are 62-71%.
- Interim data showed the treatment was well-tolerated, and no dose-limiting toxicities were observed.
- Three patients remained on treatment for more than one cycle.
- The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts.
- Price Action: BPTH shares are up 19.5% at $8.4 in the premarket trading on the last check Monday.
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