The trial’s safety segment is designed to evaluate two doses (60mg/m2 and 90mg/m2) of Liposomal Grb-2 in combination with Ara-C front line therapy, while each dose group will include three patients with AML for a total of six patients.
The company said that the endpoint of this trial segment is safety of the combination of the two drugs.
Bio-Path president and chief executive officer Peter Nielsen said: "This is a key milestone for Bio-Path and, after demonstrating a clean safety profile of the drug as a mono therapy, we are excited to evaluate the compound in its intended use in combination with an existing chemotherapeutic agent.
"Upon successful completion of this safety segment and review by the FDA, we would then move into a broader efficacy segment of the study."
The clinical trial is being conducted at MD Anderson Cancer Center and results of this portion are expected to be reported in the second half of 2015.
The company is focused on developing therapeutic products using its liposomal delivery technology designed to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion.