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Bio-Path Holdings Inc (NASDAQ: 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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