BerGenBio AS announced that the FDA has granted Orphan Drug designation to BGB324 for the treatment of acute myeloid leukemia (AML).

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Earlier this month BerGenBio announced that the first patient has been dosed in its multi-center Phase 1b trial of BGB324 in patients with AML. The two-part trial will primarily investigate the safety and tolerability of BGB324 when administered as a single agent and in combination with a standard-of-care drug (cytarabine). The company plans to announce data from this trial in 2015. Additional clinical trials with BGB324 in non-small cell lung cancer are currently underway.

BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition (EMT), which is a key driver in drug-resistance and metastasis.

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