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First Cohort Successfully Completed In Bio-Path Holdings' Phase I Clinical Trial Of Lead Product Candidate Liposomal Grb-2 In Leukemia

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 first 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 suggests some possible anti-leukemia activity.

A total of 14 patients were enrolled in the first cohort of the study. All patients had failed prior therapies. Of the 14 patients, one patient withdrew prior to treatment and 13 were treated. Of the treated patients, six were evaluable and seven 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 5 mg/m 2 twice a week for four weeks, for a total of eight doses. Six evaluable patients comprised the completed first dose cohort. Preliminary results suggest that Liposomal Grb-2, at a dose of 5 mg/m 2 is well tolerated. In addition, there is already a suggestion of possible anti-leukemia activity, even at the low starting dose used in the first cohort. The protocol for the clinical trial includes dose escalation of 5, 10, 20, 40 and 50 mg/m 2.

Of the six evaluable patients, lab parameters for blasts and bone marrow demonstrated possible anti-leukemia activity. Two patients had transient improvement and/or stable disease and received a total of five cycles each, representing five months on treatment with the drug. In addition, two patients had transient improvement on leukemia cutis lesions.

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