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Bio-Path Holdings Successfully Completes Fourth Cohort In Phase I Clinical Trial Of Lead Product Candidate Liposomal Grb-2 In Leukemia

Bio-Path Holdings, Inc. (OTCQX: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid antisense cancer drugs, today announced that it has completed treatment of the fourth dosage cohort in its Phase I clinical trial of its lead product candidate, BP-100-1.01 (Liposomal Grb-2), which is a systemic treatment for blood cancers, including acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson Cancer Center). The drug’s safety profile continues to be favorable, with no treatment-related serious adverse events reported, and data continues to suggest some possible anti-leukemia activity. Due to the favorable safety profile of Liposomal Grb-2 demonstrated to date, Bio-Path announced plans to integrate higher dosing into the Phase I clinical trial.

Separately, Bio-Path provided an update on clinical development of Liposomal Grb-2 announcing 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.

Completion of Cohort 4

A total of three patients were enrolled and dosed in the fourth cohort of the study. All three patients completed the 28-day treatment cycle and were evaluable. Liposomal Grb-2 is systemically delivered by intravenous injection. Patients received a dose of 40 mg/m 2 twice a week for four weeks, for a total of eight doses. Preliminary results suggest that Liposomal Grb-2, at a dose of 40 mg/m 2 is well tolerated. The protocol for the clinical trial includes dose escalation of 5, 10, 20, 40 and 50 mg/m 2. The expected dose for treatment is 45 mg/m 2 based on pre-clinical studies in animals.

As was the case with the three previous cohorts, there continued to be a suggestion of possible anti-leukemia activity. One patient stabilized and qualified to receive additional treatment. Two other AML patients with more than 90 percent blast count did not receive extended treatment.

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