Grb-2 (Growth factor Receptor Bound protein-2) is an adaptor protein that links tyrosine kinases such as bcr-abl with their downstream signaling molecules, including MAPK and AKT, which are critical regulators of cancer proliferation and survival. Liposomal Grb-2 seeks to suppress the function or expression of Grb-2, interrupt the vital signaling function and have a therapeutic effect.
The Phase I clinical trial is being conducted at the MD Anderson Cancer Center and is a dose-escalating study to determine the safety and tolerance of escalating doses of Liposomal Grb-2, as well as the optimal biologically active dose. The study seeks a total of 18 to 30 evaluable patients and will evaluate five doses of Liposomal Grb-2 in five cohorts. An evaluable patient is a patient who has been able to complete the four-week treatment cycle.
As of June 2012, the Company has successfully completed three cohorts of the study. The drug has been well tolerated and possible anti-leukemia effects have been observed. Enrollment is currently on-going for the fourth cohort of the trial and Bio-Path anticipates that enrollment for the Phase I study will be completed by the end of 2012.