Bio-Path Jumps Nearly 600% In 2 Days: What You Need To Know

Bio-Path Holdings Inc BPTH shares are on a tear, advancing over 160 percent on roughly 37 times their average volume Wednesday and trading up more than 200 percent Thursday afternoon. 

What has led to the buoyant sentiment toward this thinly traded nano-cap biotech?

The Catalyst

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; the company some changes to the clinical program with an eye toward 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.

BioPath shares were trading up 236.94 percent to $40.50 at the time of publication Thursday. 

Incidentally, the company enacted a 1-for-20 reverse stock split in January.

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