FDA grants orphan drug status to AML drug candidate

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The US FDA has granted orphan-drug status to EntreMed's ENMD-2076, the company's lead cancer drug candidate designed to treat acute myeloid leukemia (AML). This status comes on the basis preclinical (i.e. non-human) studies, in which ENMD-2076 was shown to be effective in inhibiting a certain aspect of mitosis or cell division that is often "over-expressed in human cancers." It was also based on an ongoing Phase I clinical trial.

Acute myeloid leukemia represents about twenty percent of all leukemias and for the huge majority of patients, no matter their age or gender, the prognosis is not good.

By Ross Bonander

Source: MedicalNewsToday

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