ChemGenex Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA for Omapro (omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. Omapro is currently in global Phase 2/3 clinical trials for CML and has been granted Orphan Drug designation as well as Fast Track status by the FDA.

Omapro is a subcutaneously administered, first-in-class cetaxine that inhibits protein translation of short-lived oncoproteins in leukemic cells.

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