Bio-Path Holdings announced positive findings from its Phase 1/1b clinical trial of BP1002, a drug designed to treat refractory/relapsed acute myeloid leukemia (AML), including cases resistant to venetoclax. One patient in the third cohort demonstrated stable disease and a significant reduction in blast count after a single treatment cycle. The trial has now advanced to the fourth cohort, testing a higher 90 mg/m² dose.
This development is particularly encouraging for AML patients who have relapsed after initial venetoclax-based treatments. These patients currently face a dismal prognosis, with a median overall survival of less than three months and limited effective salvage therapies. BP1002 offers a potential new treatment avenue by targeting Bcl-2 at the mRNA level, which may circumvent venetoclax resistance mechanisms. The accelerated enrollment in the third cohort underscores the urgent need for new therapies in this patient population.
The Phase 1/1b trial is being conducted at prominent U.S. cancer centers and employs a treatment cycle of two doses per week for four weeks. Following completion of the BP1002 monotherapy cohorts, the trial will proceed to a Phase 1b segment evaluating BP1002 in combination with decitabine.
This positive patient response and the progression to a higher dose cohort represent significant milestones in the development of BP1002. It strengthens the potential of BP1002 as a viable treatment option for relapsed/refractory AML, particularly for patients who have developed resistance to venetoclax. Further results from this trial are eagerly anticipated, as they could pave the way for a much-needed new therapy in this challenging disease area.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
