Bio-Path Releases Early Cut Data From Mid-Stage Prexigebersen Trial In Acute Myeloid Leukemia

Bio-Path Holdings Inc BPTH reported interim data from Stage 2 of the company's Phase 2 study of prexigebersen in combination with decitabine and venetoclax for acute myeloid leukemia (AML). 

Prexigebersen continues to be well-tolerated and has shown compelling efficacy results in two reporting cohorts, including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, exceeding outcomes with frontline therapy. 

Fourteen newly diagnosed patients were evaluable in Cohort 1 and treated with at least one cycle of the prexigebersen, decitabine and venetoclax combination therapy. 

Twelve of the fourteen evaluable patients (86%) achieved complete remission (CR/CRi), and two (14%) achieved partial remission (PR). 

In total, 100% of the evaluable patients had a response to treatment.

The complete remission rate (CR/CRi) of (86%) for the evaluable patients in Cohort 1 is significantly higher than complete remission (CR/CRi) rates (62%) for newly diagnosed patients treated with the frontline combination of decitabine and venetoclax. 

Fourteen refractory/relapsed evaluable AML patients in Cohort 2 were treated with at least one cycle of the prexigebersen, decitabine, and venetoclax combination therapy. 

Eight of the fourteen evaluable patients (57%) achieved complete remission (CR/CRi), two (14%) achieved partial remission (PR), and three (22%) achieved stable disease. 

In total, 93% of the evaluable patients had a response to treatment. The complete remission rate (CR/CRi) of (57%) for the evaluable refractory and relapsed patients in Cohort 2 is significantly higher than the complete remission (CR/CRi) rate (21%) for refractory/relapsed patients treated with the combination treatment of decitabine and venetoclax. 

Price Action: BPTH shares are down 7.57% at $0.98 on the last check Tuesday.