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December 9, 2013
11:25 EDTBPTHBio-Path Holdings announces Liposomal Grb-2 Phase 1 data presented
Bio-Path Holdings announced the presentation of Phase I data from Bio-Path’s clinical trial evaluating its lead product candidate, Liposomal Grb-2 in hematological cancers. The study was included in the first five cohorts of the study. The sixth cohort of the study is ongoing, and Bio-Path expects to have enrollment completed in 1Q14. The clinical trial was a standard dose-finding study. The starting dose was 5 mg/m2 twice weekly intravenously over two to three hours for 28 days and proceeded through doses of 10, 20, 40, and 60 mg/m2. A total of 28 patients who had failed other therapies were included in the study and 18 patients were evaluable. Preliminary results suggest that BP-100-1.01 at doses up to 60 mg/m2 is well tolerated and there is suggestion of anti-leukemia activity. Of the evaluable patients, all showed a transient drop in circulating or bone marrow blast percentage. Doses administered in Cohorts 1-5 expected to be below Optimal Biological Dose. As the study progresses it is anticipated that clearer signs of activity will be noted.
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