Bio-Path Announces Clinical Update to Interim Analysis of Phase 2 Prexigebersen Trial in Acute Myeloid Leukemia

Bio-Path Holdings (NASDAQ:BPTH) has announced a clinical update on its interim analysis from the Phase 2 trial of prexigebersen (BP1001) for treating acute myeloid leukemia (AML).

As quoted in the press release:

The open-label Phase 2 study in Stage 1 evaluated the efficacy and safety of prexigebersen in conjunction with low dose cytarabine (LDAC), a therapeutic regimen well-established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy.  The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than would be expected with LDAC alone in a de novo patient population. Subsequently, Stage 2 of the study added a second cohort that is evaluating the efficacy and safety of prexigebersen in conjunction with Decitabine in addition to the cohort evaluating prexigebersen in conjunction with LDAC.

In April 2018, Bio-Path completed an initial interim analysis of 17 evaluable patients from Stage 1 of the Phase 2 study.  These results showed a promising safety and efficacy profile with 47% of patients having a response comprised of four complete response (CR) patients, including one CR_i (complete response with incomplete hematologic recovery) and four patients with stable disease.  Recently, the data from the 17 evaluable patients was updated, and following a meeting with the principal investigators of the study, those results now show that the efficacy profile has improved to where 11 (65%) of the 17 evaluable patients had a response, including five (29%) who achieved CR (including one CR_i) and one morphologic leukemia free state (MLFS), and six stable disease responses, including two patients who had greater than a 50% reduction in bone marrow blasts. Importantly, through investigation by the principal investigators, it was observed that 68% of these patients were secondary AML patients, an extremely difficult class to treat.

The efficacy data from the 17 evaluable patients was very favorable in this challenging population compared to the reported CR (complete response), CRp (complete response with incomplete platelet recovery), and CRi rates with LDAC treatment alone of 7-13%¹ in this patient population.  Additionally, a study of newly approved Venetoclax plus LDAC in these newly diagnosed patients reported a 42% CR/CRh (complete response with incomplete hematologic response) response rate; however, this study had only 46% secondary AML compared to 68% in the Bio-Path 17-patient interim analysis.

Click here to read the full press release.