$BPTH Posts Positive Phase 2 Trials for Leukemia Drug

Bio-Path released updated Phase 2 data for its lead candidate prexigebersen, codenamed BP1001, for treating acute myeloid leukemia, or AML , and also divulged a plan of action for taking the compound through clinical development toward registration.

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.

What's Next:

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.


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