Updated data from the Stage 1 of the Phase 2 study that evaluated the efficacy and safety of prexigebersen in conjunction with the low-dose chemotherapy regimen cytarabine in 17 newly diagnosed AML patients revealed that the proportion of patients showing a response increased from 47 percent when assessed in April 2018 to 65 percent.
Of the patients showing a response, 5, or 29 percent, showed a complete response compared to the benchmarked percentage of 7-13 percent.
AML: A Cancer Of Blood Cells:
AML is a form of blood cancer that develops in the bone marrow, where blood cells originate. It afflicts a group of white blood cells called myeloid cells that develop into mature blood cells such as red blood cells, white blood cells and platelets.
A patient with AML will see rapid accumulation of immature myeloid cells in the blood, resulting in a drop of other blood cell types.
BP1001's Mode Of Action:
Prexigebersen is a neutral-charge, liposome-incorporated antisense drug designed to inhibit protein synthesis of growth factor receptor bound protein 2, or Grb2.
Grb2 has a role to play in cancer cell activation via the RAS pathway.
Inhibition of Grb2 is found to halt cell proliferation and enhance cell killing by chemotherapeutic agents without added toxicity.
A Lucrative Market:
AML accounts for roughly 36 percent of all leukemias, with about 20,000 new cases diagnosed each year, Bio-Path said, citing National Cancer Institute estimates.
A critically unmet need exists for non-toxic therapies for older, fragile AML patients who are unfit or ineligible for high-dose chemotherapy or a stem cell transplant.
Bio-Path said it believes it now has a plan with definable paths to registration.
It plans to amend the Stage 2 prexigebersen + decitabine Phase 2 AML cohort in untreated new patients to add untreated high-risk myelodysplastic syndrome, or MDS , patients.
The company also intends to cancel the Stage 2 prexigebersen + LDAC Phase 2 AML cohort in untreated de novo patients.
It also plans to test a triple combo of prexigebersen + decitabine + venetoclax for untreated AML and high-risk MDS patients in a registration-directed trial to determine if more durable responses and longer survival are observed compared to patients treated with the decitabine + venetoclax combination.
The next major catalyst for Bio-Path will be the fourth-quarter results expected sometime in the next month.