Bio-Path Holdings Inc. (BPTH) shares made an incredible run on Wednesday after the company announced interim results from its midstage leukemia trial.
Specifically, the firm announced a clinical update to the previously reported interim analysis from the Phase 2 trial of prexigebersen (BP1001) for the treatment of acute myeloid leukemia (AML). Bio-Path also provided its plans for the compound’s clinical development moving forward toward registration.
The study 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.
In April 2018, Bio-Path completed an initial interim analysis of 17 evaluable patients and these results showed a promising safety and efficacy profile with 47% of patients having a response comprised of four complete response (CR) patients.
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 CRi) 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.
Peter Nielsen, president and CEO of Bio-Path, commented:
These updated interim data from Stage 1 of our Phase 2 study of prexigebersen in de novo AML patients give strong evidence of the safety and efficacy profile of our lead compound and underscore its potential to provide meaningful treatment improvement in this difficult-to-treat patient population. We were particularly pleased with these results, especially when you consider that the large percentage of these patients are secondary AML patients. The CR/CRp/CRi rate for LDAC treatment alone for the class of patients in this study was benchmarked at 7-13%1, whereas prexigebersen treatment with LDAC is currently showing a 29% CR/CRi/MLFS rate, with a highly favorable safety profile.
Shares of Bio-Path were last seen up about 180% at $12.89, in a 52-week range of $1.61 to $61.80. The consensus price target is $15.00.