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

Bio-Path Holdings, Inc. (OTC BB: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has completed treatment of the third 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 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.

A total of three patients were enrolled and dosed in the third 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 20 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 20 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 two previous cohorts, there continued to be a suggestion of possible anti-leukemia activity, as all three patients stabilized. As such, all three patients are receiving or will receive additional treatment cycles. In the protocol of the clinical trial, a patient exhibits stable disease if, in the opinion of the principal investigator, there is no clinically significant change in the disease. One patient, from this cohort, with AML had bone marrow blasts reduced by 60 percent during the first treatment cycle to within normal parameters and continued with a second treatment cycle.

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