On November 14, 2012, Bio-Path reported it had completed the fourth cohort of the Phase I clinical trial evaluating Liposomal Grb-2 in blood cancers. The drug’s safety profile continues to be favorable with no treatment-related serious adverse events reported and data suggests possible anti-leukemia activity. The clinical trial is being conducted at the MD Anderson Cancer Center. Due to the favorable safety profile, Bio-Path announced plans to integrate higher dosing into the Phase I trial. All necessary steps to proceed with the revised protocol are expected to be completed by the end of December 2012. Assuming that only two additional cohorts, testing higher doses of the drug candidate are needed, dosing in the Phase I clinical trial should be completed by mid-year 2013.
In addition, Bio-Path announced its intent to conduct three Phase II clinical trials of Liposomal Grb-2 salvage therapy in combination with frontline therapy in three different leukemia disease types: AML, CML and MDS. The Company anticipates starting this phase of development in the second half of 2013.
BIO-PATH CODE OF ETHICS AND BUSINESS CONDUCT