The first participant has been dosed in the amended second stage of a Phase 2 clinical trial evaluating Bio-Path Holdings’ (NASDAQ:BPTH) prexigebersen (BP1001), added to first-line venetoclax and decitabine, in acute myeloid leukemia (AML) patients.
Open-label Stage 1 assessed prexigebersen and low-dose cytarabine but oncologists favored decitabine.
Stage 2 has three cohorts, the first-untreated AML patients, the second-relapsed/refractory AML and the third- relapsed/refractory patients resistant to or intolerant of prexigebersen and decitabine. The first two cohorts will receive the triplet therapy.
The primary endpoint is the number of patients achieving complete remission.
If preliminary data are positive, the company plans to convert the study into a registration trial to support a U.S. application for accelerated approval.
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