Bio-Path Holdings, Inc. (OTCBB: 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 second dosage cohort in the Company’s 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 was well tolerated with no treatment-related serious adverse events reported and data continues to suggest some possible anti-leukemia activity.
A total of six patients were enrolled and dosed in the second cohort of the study. Three evaluable patients completed the 28-day treatment cycle and comprised the completed second dose cohort. Three other patients failed to complete a full 28-day cycle because of disease progression. Liposomal Grb-2 is systemically delivered by intravenous injection. Patients received a dose of 10 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 10 mg/m 2 is well tolerated. In addition, there is a suggestion of possible anti-leukemia activity, even at the low doses used in the first and second cohorts. 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.
“The preliminary results being reported today for the second cohort of our clinical trial continue to be promising. As we have noted previously, the suggestion of possible anti-leukemia activity with the low doses used in the first and second cohorts is encouraging,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path. “Enrollment in the trial is also picking up momentum, evidenced by the dramatically shorter time frame it took to complete the second cohort. The third cohort is currently enrolling and we believe that this is a trend that can continue for the balance of the trial. ”