Institute of Good Manufacturing Practices India®

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Advanced BioDesign declares positive data from ODYSSEY AML study

Advanced BioDesign has disclosed initial findings from its ODYSSEY trial, examining ABD-3001 (Sefaldin) efficacy in treating refractory acute myeloid leukemia (AML). ABD-3001, a galenic form of Dimate, targets aldehyde dehydrogenase 1 (ALDH1). The adaptive Phase I/II study, initiated 15 months ago, showed promising results in over 65% of treated patients. Biological markers indicated ALDH1A1 inhibition and JNK protein phosphorylation post-treatment. Safety profiles were favorable, with no significant adverse events noted. Following encouraging outcomes, the trial plans to extend treatment cycles to assess efficacy further. Sefaldin is also under Phase I investigation for myelodysplastic syndrome and refractory AML, with preclinical studies for additional indications like breast cancer and melanoma underway.