Bio-Path Holdings announces completion of safety testing in Phase 2 trial in AML
Bio-Path Holdings announces the successful completion of the safety testing of prexigebersen in combination with decitabine in acute myeloid leukemia and myelodysplastic syndrome patients in Stage 2 of the Phase 2 clinical study. The safety segment of Stage 2 of the Phase 2 clinical trial comprised six evaluable patients who were treated with the combination of prexigebersen and decitabine. Although the treatment combination of prexigebersen and decitabine is not the treatment planned for the efficacy evaluation of Stage 2 of the Phase 2 clinical trial, the efficacy profile in this safety segment of the study was encouraging with 50% of patients having a response, including two patients showing complete responses with incomplete hematologic recovery and one patient showing partial response. For reference, in this class of AML and MDS patients, the complete response rate to treatment with decitabine alone is approximately 20%. Some patients are continuing to receive treatment. As previously reported, Stage 1 of the Phase 2 clinical trial, which treated de novo AML patients with a combination of low dose cytarabine and prexigebersen, demonstrated similar safety results and efficacy compared favorably to treatment of this class of patients with LDAC alone. We believe that prexigebersen with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapy. The recent approval of the frontline therapy venetoclax provided an opportunity for adding prexigebersen to the combination of venetoclax and decitabine for the treatment of AML and MDS patients. The first step in this process was establishing the safety of combining prexigebersen and decitabine prior to proceeding to a combination treatment of prexigebersen, decitabine and venetoclax. Bio-Path's amended Stage 2 of the Phase 2 clinical trial will have two cohorts of patients. The first cohort will include untreated AML patients as existed in the pre-amended trial but with the addition of untreated high risk MDS patients, and a second cohort will include refractory/relapsed AML patients and high risk MDS patients. Both cohorts of patients will be treated with the combination of prexigebersen, decitabine and venetoclax. The Company is finalizing amendments to add this combination treatment to Stage 2 of the Phase 2 clinical trial.