The company announced it has completed the safety testing in the second stage of its Phase 2 clinical trial in acute myeloid leukemia.
Bio-Path Holdings (NASDAQ:BPTH) has announced it has completed the safety testing of prexigebersen in combination with decitabine in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in the second stage of its Phase 2 clinical study.
As quoted in the press release:
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.
“We are especially pleased to have successfully completed this key safety segment of our Phase 2 study as it allows us to move forward to the next segment of this important clinical study, which is the final, efficacy portion of Stage 2 of the Phase 2 study,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We are in the process of completing the documentation to submit for final approval of this last portion of Stage 2 of the Phase 2 study. These results are encouraging and give us greater confidence in the successful development of this very promising combination therapy for AML and MDS patients.”
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 (33%) showing complete responses with incomplete hematologic recovery and one patient (17%) 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.